Study NCT03713619
This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE)
Submitted Date:  December 11, 2023 (v26)
Quality Control Review Has Not Concluded

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General Comments

Quality Control Review Comment provided by the National Library of Medicine:

  1. Issues noted on a previous submission of this record do not appear to have been addressed.
Open or close this module Study Identification
Unique Protocol ID: CAIN457M2301
Brief Title: This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE)
Official Title: A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).
Secondary IDs: 2018-002063-26 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2023
Overall Status: Completed
Study Start: January 31, 2019
Primary Completion: October 1, 2021 [Actual]
Study Completion: July 26, 2022 [Actual]
First Submitted: October 18, 2018
First Submitted that
Met QC Criteria:
October 19, 2018
First Posted: October 22, 2018 [Actual]
Results First Submitted: June 23, 2023
Results First Submitted that
Met QC Criteria:
Results First Posted: January 3, 2024 [Actual]
Certification/Extension
First Submitted:
July 8, 2021
Certification/Extension
First Submitted that
Met QC Criteria:
Certification/Extension
First Posted:
January 3, 2024 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: January 3, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study also assessed the safety and tolerability of secukinumab.
Detailed Description:

This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in 541 patients with moderate to severe HS. The study consisted of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there was an optional extension study (NCT04179175). Adult males and females with moderate to severe HS were included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing was once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included.

In Treatment Period 1, participants were randomized to secukinumab Q2W, secukinumab Q4W, placebo Q2W or placebo Q4W in 1:1:0.5:0.5 ratio. In Treatment Period 2, at the Week 16 visit participants initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose.

At the Week 16 visit, subjects initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose.

The primary objective was to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; secondary objectives were to assess difference in proportion of patients with HS flares, and proportion of patients with clinical response in HS related skin pain after 16 weeks of treatment. Key safety data was collected, along with Patient Reported Outcomes.

Open or close this module Conditions
Conditions: Hidradenitis Suppurativa
Keywords: acne inversa
Hidradenitis suppurativa
maladie de Verneuil
inflammatory disease
AIN457
AIN457M
secukinumab
HS
lumps
skin
lesions
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
This was a Multicenter, randomized, double-blind, placebo-controlled, parallel group study, with two secukinumab dose regimens in 541 patients with moderate to severe HS.
Number of Arms: 4
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 544 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: secukinumab 1
Secukinumab 300mg every 2 weeks
Drug: secukinumab
Secukinumab 300mg every 2 or every 4 weeks
Other Names:
  • AIN457
Active Comparator: secukinumab 2
Secukinumab 300mg every 4 weeks
Drug: secukinumab
Secukinumab 300mg every 2 or every 4 weeks
Other Names:
  • AIN457
Placebo Comparator: placebo 1
Placebo group to secukinumab 300mg every 2 weeks
Drug: Placebo
Placebo 300mg every 2 or every 4 weeks
Placebo Comparator: placebo 2
Placebo group to secukinumab 300mg every 4 weeks
Drug: Placebo
Placebo 300mg every 2 or every 4 weeks
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)
[ Time Frame: 16 weeks ]

HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration.

This endpoint was analyzed by logistic regression.

Secondary Outcome Measures:
1. Percentage Change From Baseline in AN50 Count at Week 16
[ Time Frame: Baseline, 16 weeks ]

The HS affected areas, e.g. right and left axillary (armpit), right and left gluteal ("buttock"), right and left inguinal-femoral (groin), perineal, pubic, sternal, right and left sub-mammary (breast) and others were assessed by the physician for abscesses, inflammatory nodules, draining fistulas, total fistulas, and other lesions.

Inflammatory lesions, including abscesses, nodules, draining fistulae, total fistulae and other lesions were counted. The analysis method for percentage change from baseline in abscesses and inflammatory nodules (AN) count at Week 16 was an ANCOVA model.

2. Percentage of Participants With Hidradenitis Suppurativa (HS) Flares
[ Time Frame: 16 weeks ]

Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline.

This endpoint was analyzed by logistic regression.

3. Percentage of Participants Achieving NRS30
[ Time Frame: Baseline, week 16 ]

Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 [no skin pain] to 10 [worst skin pain]).

This endpoint was analyzed by logistic regression.

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female patients ≥ 18 years of age.
  • Diagnosis of HS ≥ 1 year prior to baseline.
  • Patients with moderate to severe HS defined as:
  • A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
  • Inflammatory lesions should affect at least 2 distinct anatomic areas
  • Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.

Exclusion Criteria:

  • Total fistulae count ≥ 20 at baseline.
  • Any other active skin disease or condition that may interfere with assessment of HS.
  • Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
  • Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
  • History of hypersensitivity to any of the study drug constituents.
  • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
  • Pregnant or lactating women.
Open or close this module Contacts/Locations
Locations: United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35205
United States, Arkansas
Novartis Investigative Site
Rogers, Arkansas, United States, 72758
United States, California
Novartis Investigative Site
Anaheim, California, United States, 92807
Novartis Investigative Site
San Diego, California, United States, 92123
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33125
Novartis Investigative Site
Tampa, Florida, United States, 33612
United States, Illinois
Novartis Investigative Site
Skokie, Illinois, United States, 60077
Novartis Investigative Site
West Dundee, Illinois, United States, 60118
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02215
United States, Minnesota
Novartis Investigative Site
New Brighton, Minnesota, United States, 55112
United States, Missouri
Novartis Investigative Site
Saint Joseph, Missouri, United States, 64506
United States, North Carolina
Novartis Investigative Site
Chapel Hill, North Carolina, United States, 27516
United States, Ohio
Novartis Investigative Site
Fairborn, Ohio, United States, 45324
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15213-3403
United States, South Carolina
Novartis Investigative Site
Charleston, South Carolina, United States, 29407
United States, Tennessee
Novartis Investigative Site
Goodlettsville, Tennessee, United States, 37072-2301
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75246-1613
Novartis Investigative Site
San Antonio, Texas, United States, 78229
Argentina
Novartis Investigative Site
Buenos Aires, Argentina, C1425DKG
Argentina, Buenos Aires
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
Novartis Investigative Site
La Plata, Buenos Aires, Argentina, B1902COS
Australia, Australian Capital Territory
Novartis Investigative Site
Phillip, Australian Capital Territory, Australia, 2606
Australia, Queensland
Novartis Investigative Site
Benowa, Queensland, Australia, 4217
Australia, Victoria
Novartis Investigative Site
East Melbourne, Victoria, Australia, 3002
Austria
Novartis Investigative Site
Linz, Austria, 4020
Novartis Investigative Site
Wien, Austria, A 1090
Belgium, Brussels
Novartis Investigative Site
Bruxelles, Brussels, Belgium, 1070
Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, 1606
Novartis Investigative Site
Stara Zagora, Bulgaria, 6000
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada, N6H 5L5
Novartis Investigative Site
Peterborough, Ontario, Canada, K9J 5K2
Novartis Investigative Site
Waterloo, Ontario, Canada, N2J 1C4
Czechia
Novartis Investigative Site
Plzen, Czechia, 30460
Czechia, Prague 1
Novartis Investigative Site
Prague, Prague 1, Czechia, 11000
France
Novartis Investigative Site
Bordeaux Cedex, France, 33075
Novartis Investigative Site
Brest, France, 29609
Novartis Investigative Site
Creteil, France, 94010
Novartis Investigative Site
Lyon, France, 69437
Novartis Investigative Site
Montpellier cedex 5, France, 34295
Novartis Investigative Site
Nantes Cedex 1, France, 44093
Novartis Investigative Site
Paris 10, France, 75475
Novartis Investigative Site
Toulouse, France, 31400
Germany
Novartis Investigative Site
Bielefeld, Germany, 33647
Novartis Investigative Site
Bochum, Germany, 44791
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Halle (Saale), Germany, 06108
Novartis Investigative Site
Langenau, Germany, 89129
Novartis Investigative Site
Memmingen, Germany, 87700
Novartis Investigative Site
Muenchen, Germany, 80377
Novartis Investigative Site
Potsdam, Germany, 14467
Greece
Novartis Investigative Site
Athens, Greece, 12462
Novartis Investigative Site
Thessaloniki, Greece, 546 43
Hungary
Novartis Investigative Site
Budapest, Hungary, 1085
Novartis Investigative Site
Pecs, Hungary, 7623
India, Delhi
Novartis Investigative Site
New Delhi, Delhi, India, 110 060
India, Karnataka
Novartis Investigative Site
Mangalore, Karnataka, India, 575002
Novartis Investigative Site
Mysore, Karnataka, India, 570001
India, Maharashtra
Novartis Investigative Site
Nashik, Maharashtra, India, 422 101
Israel
Novartis Investigative Site
Jerusalem, Israel, 9112001
Novartis Investigative Site
Petach Tikva, Israel, 4941492
Italy, FI
Novartis Investigative Site
Firenze, FI, Italy, 50122
Italy, MI
Novartis Investigative Site
Milano, MI, Italy, 20122
Italy, MO
Novartis Investigative Site
Modena, MO, Italy, 41124
Italy, PI
Novartis Investigative Site
Pisa, PI, Italy, 56124
Japan
Novartis Investigative Site
Osaka, Japan, 545-8586
Japan, Aichi
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 467-8602
Japan, Chiba
Novartis Investigative Site
Kisarazu, Chiba, Japan, 292-8535
Japan, Okinawa
Novartis Investigative Site
Nakagami, Okinawa, Japan, 903 0215
Japan, Saitama
Novartis Investigative Site
Koshigaya, Saitama, Japan, 343-8555
Japan, Tokyo
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 173-8610
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of, 02841
Novartis Investigative Site
Seoul, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Republic of, 07441
Mexico, Jalisco
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44657
Mexico, Nuevo Leon
Novartis Investigative Site
Monterrey, Nuevo Leon, Mexico, 64460
Philippines
Novartis Investigative Site
Las Pinas, Philippines, 1740
Philippines, Davao
Novartis Investigative Site
Davao City, Davao, Philippines, 8000
Philippines, Metro Manila
Novartis Investigative Site
Quezon City, Metro Manila, Philippines, 1104
Poland
Novartis Investigative Site
Ossy, Poland, 42 624
Novartis Investigative Site
Wroclaw, Poland, 50 566
Poland, Mazowian
Novartis Investigative Site
Warszawa, Mazowian, Poland, 02 495
Portugal
Novartis Investigative Site
Lisboa, Portugal, 1150 314
Novartis Investigative Site
Lisboa, Portugal, 1998-018
Novartis Investigative Site
Matosinhos, Portugal, 4454 513
Novartis Investigative Site
Porto, Portugal, 4099-001
Russian Federation
Novartis Investigative Site
Kazan, Russian Federation, 420012
Novartis Investigative Site
Krasnodar, Russian Federation, 350020
Novartis Investigative Site
Saint Petersburg, Russian Federation, 197022
Novartis Investigative Site
Yaroslavl, Russian Federation, 150003
Slovakia
Novartis Investigative Site
Martin, Slovakia, 03659
Slovakia, Slovak Republic
Novartis Investigative Site
Kosice, Slovak Republic, Slovakia, 4190
Spain
Novartis Investigative Site
Barcelona, Spain, 08041
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Pontevedra, Spain, 36003
Spain, Andalucia
Novartis Investigative Site
Cadiz, Andalucia, Spain, 11009
Spain, Comunidad Valenciana
Novartis Investigative Site
Alicante, Comunidad Valenciana, Spain, 03010
Spain, Madrid
Novartis Investigative Site
Fuenlabrada, Madrid, Spain, 28942
Sweden
Novartis Investigative Site
Uppsala, Sweden, 751 85
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Geneve, Switzerland, 1205
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Turkey
Novartis Investigative Site
Antalya, Turkey, 07070
Novartis Investigative Site
Aydin, Turkey, 09100
Novartis Investigative Site
Gaziantep, Turkey, 27310
United Kingdom
Novartis Investigative Site
Barnsley, United Kingdom, S75 2EP
Novartis Investigative Site
Bristol, United Kingdom, BS2 8HN
Novartis Investigative Site
Exeter, United Kingdom, EX2 5DW
Novartis Investigative Site
Norwich, United Kingdom, NR4 7UY
United Kingdom, Manchester
Novartis Investigative Site
Salford, Manchester, United Kingdom, M6 8HD
United Kingdom, West Yorkshire
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Open or close this module IPDSharing
Plan to Share IPD: Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: January 8, 2021
Uploaded: 06/23/2023 12:08
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: July 21, 2022
Uploaded: 06/23/2023 12:12
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details Participants were enrolled in 111 study sites worldwide.
 
Arm/Group Title Secukinumab 1 - Q2W Secukinumab 2 - Q4W Placebo
Arm/Group Description Secukinumab 300mg every 2 weeks Secukinumab 300mg every 4 weeks Placebo group to secukinumab 300mg
Period Title: Treatment Period 1 (Until Week 16)
Started 182 181 181
Full Analysis Set (FAS) [1] 181 180 180
Completed 168 169 172
Not Completed 14 12 9
Reason Not Completed
Adverse Event 4 0 1
Lost to Follow-up 3 1 1
Physician Decision 1 1 1
Technical problems 1 0 0
Withdrawal by Subject 4 9 5
Misrandomized 0 0 1
Severe GCP Violation 1 1 0
[1]The FAS excluded participants who were misrandomized or had severe GCP violations
Period Title: Treatment Period 2 (After Week 16)
Started 168 169 172
Completed 131 137 143
Not Completed 37 32 29
Reason Not Completed
Adverse Event 6 5 3
Pregnancy 1 0 1
Withdrawal by Subject 26 20 16
Poor efficacy 1 2 3
Lost to Follow-up 3 3 4
Physician Decision 0 2 2

Quality Control Review Comment provided by the National Library of Medicine:

  1. The participant flow appears to include insufficient information to understand the arms/groups to which participants were assigned, the intervention strategy used in each arm/group, or how participants progressed in the study.
Open or close this module Baseline Characteristics
Arm/Group TitleSecukinumab 1 - Q2WSecukinumab 2 - Q4WPlaceboTotal
Arm/Group DescriptionSecukinumab 300mg every 2 weeksSecukinumab 300mg every 4 weeksPlacebo group to secukinumab 300mg every 4 weeksTotal of all reporting groups
Overall Number of Baseline Participants 181 180 180 541
Baseline Analysis Population Description [Not Specified]
Age, Categorical
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed181 Participants180 Participants180 Participants541 Participants
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
178
98.34%
177
98.33%
179
99.44%
534
98.71%
>=65 years
3
1.66%
3
1.67%
1
0.56%
7
1.29%
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed181 Participants180 Participants180 Participants541 Participants
37.1(12.53)35.7(11.71)35.5(10.75)36.1(11.69)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed181 Participants180 Participants180 Participants541 Participants
Female
102
56.35%
100
55.56%
102
56.67%
304
56.19%
Male
79
43.65%
80
44.44%
78
43.33%
237
43.81%
Race/Ethnicity, Customized
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed181 Participants180 Participants180 Participants541 Participants
White
145
80.11%
146
81.11%
139
77.22%
430
79.48%
Black or African American
15
8.29%
10
5.56%
12
6.67%
37
6.84%
Asian
19
10.5%
23
12.78%
24
13.33%
66
12.2%
American Indian or Alaska Native
1
0.55%
1
0.56%
2
1.11%
4
0.74%
Multiple
1
0.55%
0
0%
3
1.67%
4
0.74%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)
Description

HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration.

This endpoint was analyzed by logistic regression.

Time Frame 16 weeks
Outcome Measure Data
Analysis Population Description
Full analysis set (FAS)
 
Arm/Group TitleSecukinumab 1 - Q2WSecukinumab 2 - Q4WPlacebo
Arm/Group DescriptionSecukinumab 300mg every 2 weeksSecukinumab 300mg every 4 weeksPlacebo group to secukinumab 300mg
Overall Number of Participants Analyzed181 180 180
Measure Type: Number
Unit of Measure: Percentage of participants
45.0 41.8 33.7
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionSecukinumab 1 - Q2W, Placebo
CommentsLogistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0070
Comments[Not specified]
MethodRegression, Logistic
Comments[Not specified]
Method of EstimationEstimation ParameterOdds Ratio, log
Estimated Value1.75
Confidence Interval(2-sided) 95%
1.12 to 2.73
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionSecukinumab 2 - Q4W, Placebo
CommentsLogistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0418
Comments[Not specified]
MethodRegression, Logistic
Comments[Not specified]
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value1.48
Confidence Interval(2-sided) 95%
0.95 to 2.32
Estimation Comments[Not specified]
2. Secondary Outcome:
Title Percentage Change From Baseline in AN50 Count at Week 16
Description

The HS affected areas, e.g. right and left axillary (armpit), right and left gluteal ("buttock"), right and left inguinal-femoral (groin), perineal, pubic, sternal, right and left sub-mammary (breast) and others were assessed by the physician for abscesses, inflammatory nodules, draining fistulas, total fistulas, and other lesions.

Inflammatory lesions, including abscesses, nodules, draining fistulae, total fistulae and other lesions were counted. The analysis method for percentage change from baseline in abscesses and inflammatory nodules (AN) count at Week 16 was an ANCOVA model.

Time Frame Baseline, 16 weeks
Outcome Measure Data
Analysis Population Description
FAS
 
Arm/Group TitleSecukinumab 1 - Q2WSecukinumab 2 - Q4WPlacebo
Arm/Group DescriptionSecukinumab 300mg every 2 weeksSecukinumab 300mg every 4 weeksPlacebo group to secukinumab 300mg
Overall Number of Participants Analyzed181 180 180
Least Squares Mean (Standard Error)
Unit of Measure: percentage change from baseline
-46.8(3.33) -42.4(4.01) -24.3(4.33)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionSecukinumab 1 - Q2W, Placebo
CommentsAnalysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.0001
Comments[Not specified]
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterLeast square Mean Difference
Estimated Value-23.05
Confidence Interval(2-sided) 95%
-33.90 to -12.21
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionSecukinumab 2 - Q4W, Placebo
CommentsAnalysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0004
Comments[Not specified]
MethodANCOVA
Comments[Not specified]
Method of EstimationEstimation ParameterLeast Square Mean difference
Estimated Value-18.46
Confidence Interval(2-sided) 95%
-29.32 to -7.60
Estimation Comments[Not specified]
3. Secondary Outcome:
Title Percentage of Participants With Hidradenitis Suppurativa (HS) Flares
Description

Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline.

This endpoint was analyzed by logistic regression.

Time Frame 16 weeks
Outcome Measure Data
Analysis Population Description
FAS
 
Arm/Group TitleSecukinumab 1 - Q2WSecukinumab 2 - Q4WPlacebo 2
Arm/Group DescriptionSecukinumab 300mg every 2 weeksSecukinumab 300mg every 4 weeksPlacebo group to secukinumab 300mg
Overall Number of Participants Analyzed181 180 180
Measure Type: Number
Unit of Measure: Percentage of participants
15.4 23.2 29.0
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionSecukinumab 1 - Q2W, Placebo 2
CommentsLogistic regression analysis of Flare over 16 weeks (multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0010
Comments[Not specified]
MethodRegression, Logistic
Comments[Not specified]
Method of EstimationEstimation ParameterOdds Ratio, log
Estimated Value0.42
Confidence Interval(2-sided) 95%
0.25 to 0.73
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionSecukinumab 2 - Q4W, Placebo 2
CommentsLogistic regression analysis of Flare over 16 weeks (multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0926
Comments[Not specified]
MethodRegression, Logistic
Comments[Not specified]
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.71
Confidence Interval(2-sided) 95%
0.43 to 1.17
Estimation Comments[Not specified]
4. Secondary Outcome:
Title Percentage of Participants Achieving NRS30
Description

Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 [no skin pain] to 10 [worst skin pain]).

This endpoint was analyzed by logistic regression.

Time Frame Baseline, week 16
Outcome Measure Data
Analysis Population Description
FAS restricted to participants with baseline NRS score greater or equal to 3
 
Arm/Group TitleSecukinumab 1 - Q2WSecukinumab 2 - Q4WPlacebo
Arm/Group DescriptionSecukinumab 300mg every 2 weeksSecukinumab 300mg every 4 weeksPlacebo group to secukinumab 300mg
Overall Number of Participants Analyzed131 123 119
Measure Type: Number
Unit of Measure: Percentage of participants
34.1 32.2 23.8
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionSecukinumab 1 - Q2W, Placebo
CommentsLogistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0248
Comments[Not specified]
MethodRegression, Logistic
Comments[Not specified]
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value1.84
Confidence Interval(2-sided) 95%
1.00 to 3.40
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionSecukinumab 2 - Q4W, Placebo
CommentsLogistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.0044
Comments[Not specified]
MethodRegression, Logistic
Comments[Not specified]
Method of EstimationEstimation ParameterOdds Ratio, log
Estimated Value1.77
Confidence Interval(2-sided) 95%
1.15 to 2.0
Estimation Comments[Not specified]
Open or close this module Adverse Events
 
Time Frame Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
Adverse Event Reporting Description AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
 
Arm/Group Title AIN457 Q2W AIN457 Q4W Placebo Any AIN457 Q2W Any AIN457 Q4W Any AIN457
Arm/Group Description Subjects who were randomized to AIN457 (secukinumab) 300mg Q2W dose regimen at the study entry. Adverse events were assessed up to Week 60 Subjects who were randomized to AIN457 (secukinumab) 300mg Q4W dose regimen at the study entry. Adverse events were assessed up to Week 60 Subjects received matching placebo up to 16 weeks Subjects who received at least 1 dose of secukinumab 300 mg Q2W dose (e.g., subjects who switched from placebo to secukinumab Q2W at Week 16). Adverse events were assessed up to Week 60 Subjects who received at least 1 dose of secukinumab 300 mg Q4W dose (e.g., subjects who switched from placebo to secukinumab Q4W at Week 16). Adverse events were assessed up to Week 60 Subjects who received at least 1 dose of secukinumab
All-Cause Mortality
  AIN457 Q2WAIN457 Q4WPlaceboAny AIN457 Q2WAny AIN457 Q4WAny AIN457
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)0 / 267 (0%)0 / 533 (0%)
Serious Adverse Events
  AIN457 Q2WAIN457 Q4WPlaceboAny AIN457 Q2WAny AIN457 Q4WAny AIN457
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 13 / 181 (7.18%)9 / 180 (5%)6 / 180 (3.33%)18 / 266 (6.77%)19 / 267 (7.12%)37 / 533 (6.94%)
Cardiac disorders
Pericarditis † A 0 / 181 (0%)1 / 180 (0.56%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Tachycardia † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Gastrointestinal disorders
Abdominal pain † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Constipation † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Diarrhoea haemorrhagic † A 0 / 181 (0%)0 / 180 (0%)1 / 180 (0.56%)0 / 266 (0%)0 / 267 (0%)0 / 533 (0%)
Inguinal hernia † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Vomiting † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
General disorders
Fatigue † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Pyrexia † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Infections and infestations
Appendicitis † A 0 / 181 (0%)1 / 180 (0.56%)0 / 180 (0%)1 / 266 (0.38%)1 / 267 (0.37%)2 / 533 (0.38%)
Breast cellulitis † A 0 / 181 (0%)1 / 180 (0.56%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
COVID-19 † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)1 / 267 (0.37%)2 / 533 (0.38%)
Cellulitis † A 1 / 181 (0.55%)1 / 180 (0.56%)0 / 180 (0%)1 / 266 (0.38%)1 / 267 (0.37%)2 / 533 (0.38%)
Clostridium difficile colitis † A 0 / 181 (0%)0 / 180 (0%)1 / 180 (0.56%)0 / 266 (0%)0 / 267 (0%)0 / 533 (0%)
Infection † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Influenza † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Large intestine infection † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Peritonsillar abscess † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Pneumonia † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)2 / 267 (0.75%)2 / 533 (0.38%)
Post procedural infection † A 0 / 181 (0%)1 / 180 (0.56%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Sepsis † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Skin candida † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Sweat gland infection † A 1 / 181 (0.55%)3 / 180 (1.67%)0 / 180 (0%)1 / 266 (0.38%)3 / 267 (1.12%)4 / 533 (0.75%)
Urinary tract infection † A 0 / 181 (0%)1 / 180 (0.56%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Injury, poisoning and procedural complications
Foot fracture † A 0 / 181 (0%)0 / 180 (0%)1 / 180 (0.56%)0 / 266 (0%)0 / 267 (0%)0 / 533 (0%)
Meniscus injury † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Musculoskeletal and connective tissue disorders
Foot deformity † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic † A 0 / 181 (0%)0 / 180 (0%)1 / 180 (0.56%)0 / 266 (0%)0 / 267 (0%)0 / 533 (0%)
Non-small cell lung cancer metastatic † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Nervous system disorders
Dizziness † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Headache † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Sciatica † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Psychiatric disorders
Suicidal ideation † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Suicide attempt † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Renal and urinary disorders
C3 glomerulopathy † A 0 / 181 (0%)1 / 180 (0.56%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Ureterolithiasis † A 0 / 181 (0%)0 / 180 (0%)1 / 180 (0.56%)0 / 266 (0%)0 / 267 (0%)0 / 533 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Sleep apnoea syndrome † A 0 / 181 (0%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Skin and subcutaneous tissue disorders
Hidradenitis † A 3 / 181 (1.66%)3 / 180 (1.67%)2 / 180 (1.11%)4 / 266 (1.5%)4 / 267 (1.5%)8 / 533 (1.5%)
Vascular disorders
Hypertensive emergency † A 0 / 181 (0%)1 / 180 (0.56%)0 / 180 (0%)0 / 266 (0%)1 / 267 (0.37%)1 / 533 (0.19%)
Thrombosis † A 1 / 181 (0.55%)0 / 180 (0%)0 / 180 (0%)1 / 266 (0.38%)0 / 267 (0%)1 / 533 (0.19%)
Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA (25.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
  AIN457 Q2WAIN457 Q4WPlaceboAny AIN457 Q2WAny AIN457 Q4WAny AIN457
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 135 / 181 (74.59%)132 / 180 (73.33%)88 / 180 (48.89%)184 / 266 (69.17%)183 / 267 (68.54%)367 / 533 (68.86%)
Gastrointestinal disorders
Abdominal pain † A 7 / 181 (3.87%)6 / 180 (3.33%)1 / 180 (0.56%)8 / 266 (3.01%)10 / 267 (3.75%)18 / 533 (3.38%)
Abdominal pain upper † A 4 / 181 (2.21%)5 / 180 (2.78%)1 / 180 (0.56%)4 / 266 (1.5%)9 / 267 (3.37%)13 / 533 (2.44%)
Constipation † A 1 / 181 (0.55%)5 / 180 (2.78%)0 / 180 (0%)1 / 266 (0.38%)5 / 267 (1.87%)6 / 533 (1.13%)
Diarrhoea † A 11 / 181 (6.08%)16 / 180 (8.89%)9 / 180 (5%)12 / 266 (4.51%)24 / 267 (8.99%)36 / 533 (6.75%)
Nausea † A 4 / 181 (2.21%)8 / 180 (4.44%)7 / 180 (3.89%)6 / 266 (2.26%)13 / 267 (4.87%)19 / 533 (3.56%)
Toothache † A 7 / 181 (3.87%)6 / 180 (3.33%)4 / 180 (2.22%)9 / 266 (3.38%)7 / 267 (2.62%)16 / 533 (3%)
Vomiting † A 5 / 181 (2.76%)7 / 180 (3.89%)0 / 180 (0%)6 / 266 (2.26%)9 / 267 (3.37%)15 / 533 (2.81%)
General disorders
Asthenia † A 3 / 181 (1.66%)4 / 180 (2.22%)4 / 180 (2.22%)5 / 266 (1.88%)4 / 267 (1.5%)9 / 533 (1.69%)
Chest pain † A 0 / 181 (0%)5 / 180 (2.78%)0 / 180 (0%)0 / 266 (0%)5 / 267 (1.87%)5 / 533 (0.94%)
Fatigue † A 6 / 181 (3.31%)11 / 180 (6.11%)8 / 180 (4.44%)8 / 266 (3.01%)13 / 267 (4.87%)21 / 533 (3.94%)
Pyrexia † A 13 / 181 (7.18%)8 / 180 (4.44%)2 / 180 (1.11%)16 / 266 (6.02%)12 / 267 (4.49%)28 / 533 (5.25%)
Hepatobiliary disorders
Hepatic steatosis † A 4 / 181 (2.21%)2 / 180 (1.11%)2 / 180 (1.11%)4 / 266 (1.5%)3 / 267 (1.12%)7 / 533 (1.31%)
Infections and infestations
Bronchitis † A 5 / 181 (2.76%)6 / 180 (3.33%)3 / 180 (1.67%)5 / 266 (1.88%)8 / 267 (3%)13 / 533 (2.44%)
COVID-19 † A 5 / 181 (2.76%)3 / 180 (1.67%)0 / 180 (0%)6 / 266 (2.26%)7 / 267 (2.62%)13 / 533 (2.44%)
Cellulitis † A 4 / 181 (2.21%)3 / 180 (1.67%)4 / 180 (2.22%)6 / 266 (2.26%)6 / 267 (2.25%)12 / 533 (2.25%)
Conjunctivitis † A 5 / 181 (2.76%)4 / 180 (2.22%)1 / 180 (0.56%)5 / 266 (1.88%)6 / 267 (2.25%)11 / 533 (2.06%)
Ear infection † A 3 / 181 (1.66%)4 / 180 (2.22%)0 / 180 (0%)3 / 266 (1.13%)4 / 267 (1.5%)7 / 533 (1.31%)
Folliculitis † A 4 / 181 (2.21%)4 / 180 (2.22%)2 / 180 (1.11%)6 / 266 (2.26%)4 / 267 (1.5%)10 / 533 (1.88%)
Fungal skin infection † A 4 / 181 (2.21%)0 / 180 (0%)0 / 180 (0%)4 / 266 (1.5%)0 / 267 (0%)4 / 533 (0.75%)
Gastroenteritis † A 8 / 181 (4.42%)4 / 180 (2.22%)1 / 180 (0.56%)8 / 266 (3.01%)4 / 267 (1.5%)12 / 533 (2.25%)
Influenza † A 1 / 181 (0.55%)6 / 180 (3.33%)4 / 180 (2.22%)1 / 266 (0.38%)6 / 267 (2.25%)7 / 533 (1.31%)
Nasopharyngitis † A 32 / 181 (17.68%)24 / 180 (13.33%)13 / 180 (7.22%)40 / 266 (15.04%)29 / 267 (10.86%)69 / 533 (12.95%)
Pharyngitis † A 7 / 181 (3.87%)5 / 180 (2.78%)1 / 180 (0.56%)8 / 266 (3.01%)7 / 267 (2.62%)15 / 533 (2.81%)
Sinusitis † A 4 / 181 (2.21%)2 / 180 (1.11%)2 / 180 (1.11%)7 / 266 (2.63%)2 / 267 (0.75%)9 / 533 (1.69%)
Suspected COVID-19 † A 5 / 181 (2.76%)3 / 180 (1.67%)0 / 180 (0%)6 / 266 (2.26%)7 / 267 (2.62%)13 / 533 (2.44%)
Tonsillitis † A 6 / 181 (3.31%)2 / 180 (1.11%)1 / 180 (0.56%)7 / 266 (2.63%)4 / 267 (1.5%)11 / 533 (2.06%)
Upper respiratory tract infection † A 9 / 181 (4.97%)13 / 180 (7.22%)4 / 180 (2.22%)12 / 266 (4.51%)17 / 267 (6.37%)29 / 533 (5.44%)
Urinary tract infection † A 9 / 181 (4.97%)8 / 180 (4.44%)3 / 180 (1.67%)10 / 266 (3.76%)10 / 267 (3.75%)20 / 533 (3.75%)
Vulvovaginal candidiasis † A 4 / 181 (2.21%)2 / 180 (1.11%)0 / 180 (0%)4 / 266 (1.5%)3 / 267 (1.12%)7 / 533 (1.31%)
Vulvovaginal mycotic infection † A 6 / 181 (3.31%)2 / 180 (1.11%)1 / 180 (0.56%)7 / 266 (2.63%)4 / 267 (1.5%)11 / 533 (2.06%)
Injury, poisoning and procedural complications
Ligament sprain † A 6 / 181 (3.31%)4 / 180 (2.22%)0 / 180 (0%)8 / 266 (3.01%)4 / 267 (1.5%)12 / 533 (2.25%)
Investigations
Amylase increased † A 3 / 181 (1.66%)4 / 180 (2.22%)0 / 180 (0%)3 / 266 (1.13%)5 / 267 (1.87%)8 / 533 (1.5%)
Lipase increased † A 8 / 181 (4.42%)7 / 180 (3.89%)2 / 180 (1.11%)8 / 266 (3.01%)9 / 267 (3.37%)17 / 533 (3.19%)
SARS-CoV-2 test negative † A 6 / 181 (3.31%)5 / 180 (2.78%)2 / 180 (1.11%)8 / 266 (3.01%)7 / 267 (2.62%)15 / 533 (2.81%)
SARS-CoV-2 test positive † A 2 / 181 (1.1%)4 / 180 (2.22%)0 / 180 (0%)4 / 266 (1.5%)5 / 267 (1.87%)9 / 533 (1.69%)
Weight increased † A 2 / 181 (1.1%)5 / 180 (2.78%)2 / 180 (1.11%)3 / 266 (1.13%)5 / 267 (1.87%)8 / 533 (1.5%)
White blood cell count increased † A 1 / 181 (0.55%)2 / 180 (1.11%)4 / 180 (2.22%)3 / 266 (1.13%)2 / 267 (0.75%)5 / 533 (0.94%)
Metabolism and nutrition disorders
Hyperuricaemia † A 4 / 181 (2.21%)3 / 180 (1.67%)0 / 180 (0%)4 / 266 (1.5%)3 / 267 (1.12%)7 / 533 (1.31%)
Musculoskeletal and connective tissue disorders
Arthralgia † A 11 / 181 (6.08%)6 / 180 (3.33%)8 / 180 (4.44%)14 / 266 (5.26%)9 / 267 (3.37%)23 / 533 (4.32%)
Back pain † A 7 / 181 (3.87%)8 / 180 (4.44%)8 / 180 (4.44%)7 / 266 (2.63%)12 / 267 (4.49%)19 / 533 (3.56%)
Pain in extremity † A 3 / 181 (1.66%)4 / 180 (2.22%)5 / 180 (2.78%)5 / 266 (1.88%)5 / 267 (1.87%)10 / 533 (1.88%)
Nervous system disorders
Dizziness † A 6 / 181 (3.31%)3 / 180 (1.67%)3 / 180 (1.67%)7 / 266 (2.63%)5 / 267 (1.87%)12 / 533 (2.25%)
Headache † A 33 / 181 (18.23%)32 / 180 (17.78%)14 / 180 (7.78%)39 / 266 (14.66%)46 / 267 (17.23%)85 / 533 (15.95%)
Migraine † A 5 / 181 (2.76%)1 / 180 (0.56%)0 / 180 (0%)5 / 266 (1.88%)3 / 267 (1.12%)8 / 533 (1.5%)
Psychiatric disorders
Depression † A 4 / 181 (2.21%)2 / 180 (1.11%)2 / 180 (1.11%)6 / 266 (2.26%)3 / 267 (1.12%)9 / 533 (1.69%)
Reproductive system and breast disorders
Dysmenorrhoea † A 1 / 181 (0.55%)1 / 180 (0.56%)4 / 180 (2.22%)2 / 266 (0.75%)4 / 267 (1.5%)6 / 533 (1.13%)
Respiratory, thoracic and mediastinal disorders
Cough † A 4 / 181 (2.21%)8 / 180 (4.44%)1 / 180 (0.56%)7 / 266 (2.63%)10 / 267 (3.75%)17 / 533 (3.19%)
Oropharyngeal pain † A 9 / 181 (4.97%)5 / 180 (2.78%)3 / 180 (1.67%)11 / 266 (4.14%)7 / 267 (2.62%)18 / 533 (3.38%)
Rhinorrhoea † A 8 / 181 (4.42%)2 / 180 (1.11%)2 / 180 (1.11%)9 / 266 (3.38%)4 / 267 (1.5%)13 / 533 (2.44%)
Skin and subcutaneous tissue disorders
Acne † A 4 / 181 (2.21%)5 / 180 (2.78%)2 / 180 (1.11%)5 / 266 (1.88%)6 / 267 (2.25%)11 / 533 (2.06%)
Dermatitis † A 3 / 181 (1.66%)4 / 180 (2.22%)1 / 180 (0.56%)4 / 266 (1.5%)5 / 267 (1.87%)9 / 533 (1.69%)
Dermatitis contact † A 3 / 181 (1.66%)6 / 180 (3.33%)0 / 180 (0%)3 / 266 (1.13%)6 / 267 (2.25%)9 / 533 (1.69%)
Eczema † A 8 / 181 (4.42%)6 / 180 (3.33%)1 / 180 (0.56%)9 / 266 (3.38%)9 / 267 (3.37%)18 / 533 (3.38%)
Hidradenitis † A 16 / 181 (8.84%)17 / 180 (9.44%)23 / 180 (12.78%)28 / 266 (10.53%)26 / 267 (9.74%)54 / 533 (10.13%)
Intertrigo † A 10 / 181 (5.52%)7 / 180 (3.89%)2 / 180 (1.11%)11 / 266 (4.14%)8 / 267 (3%)19 / 533 (3.56%)
Pruritus † A 11 / 181 (6.08%)6 / 180 (3.33%)2 / 180 (1.11%)15 / 266 (5.64%)8 / 267 (3%)23 / 533 (4.32%)
Psoriasis † A 6 / 181 (3.31%)5 / 180 (2.78%)1 / 180 (0.56%)6 / 266 (2.26%)5 / 267 (1.87%)11 / 533 (2.06%)
Rash † A 4 / 181 (2.21%)4 / 180 (2.22%)1 / 180 (0.56%)6 / 266 (2.26%)5 / 267 (1.87%)11 / 533 (2.06%)
Seborrhoeic dermatitis † A 4 / 181 (2.21%)5 / 180 (2.78%)2 / 180 (1.11%)6 / 266 (2.26%)6 / 267 (2.25%)12 / 533 (2.25%)
Vascular disorders
Hypertension † A 6 / 181 (3.31%)4 / 180 (2.22%)2 / 180 (1.11%)8 / 266 (3.01%)5 / 267 (1.87%)13 / 533 (2.44%)
Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA (25.0)
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact:
Name/Official Title:
Study Director
Organization:
Novarts Pharmaceuticals
Phone:
+1 (862) 778-8300
Email:
novartis.email@novartis.com

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