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Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE)

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ClinicalTrials.gov Identifier: NCT03713632
Recruitment Status : Completed
First Posted : October 22, 2018
Results First Posted : August 2, 2023
Last Update Posted : November 1, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE October 22, 2018
Results First Submitted Date  ICMJE July 12, 2023
Results First Posted Date  ICMJE August 2, 2023
Last Update Posted Date November 1, 2023
Actual Study Start Date  ICMJE February 25, 2019
Actual Primary Completion Date September 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2023)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Proportion of patients with Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: 16 weeks ]
HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses or in the number of draining fistulae.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2023)
  • Percentage Change From Baseline in AN Count [ Time Frame: Baseline, 16 weeks ]
    Percent change from baseline in abscesses and inflammatory nodules (AN) count. This endpoint was analyzed by analysis of covariance.
  • 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.
  • Percentage of Participants Achieving NRS30 [ Time Frame: 16 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Proportion of patients with HS flares [ Time Frame: 16 weeks ]
    Patients who experience at least one flare over 16 weeks, flare defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline
  • Participants achieving NRS30 [ Time Frame: 16 weeks ]
    Patients achieving 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)
Official Title  ICMJE A Randomized, Double-blind, Multicenter 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 (SUNRISE)
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 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • Drug: Secukinumab
    Secukinumab 300mg every 2 or every 4 weeks
  • Drug: Placebo
    Placebo 300mg every 2 or every 4 weeks
Study Arms  ICMJE
  • Active Comparator: Secukinumab 1
    Secukinumab 300mg every 2 weeks
    Intervention: Drug: Secukinumab
  • Active Comparator: Secukinumab 2
    Secukinumab 300mg every 4 weeks
    Intervention: Drug: Secukinumab
  • Placebo Comparator: Placebo 1
    Placebo group to secukinumab 300mg every 2 weeks
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo 2
    Placebo group to secukinumab 300mg every 4 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2023)
545
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)
471
Actual Study Completion Date  ICMJE July 19, 2022
Actual Primary Completion Date September 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Bulgaria,   Canada,   Colombia,   Croatia,   Czechia,   Denmark,   France,   Germany,   Greece,   Guatemala,   Hungary,   India,   Israel,   Italy,   Lebanon,   Lithuania,   Malaysia,   Netherlands,   Philippines,   Poland,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713632
Other Study ID Numbers  ICMJE CAIN457M2302
2018-002062-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

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

Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Lead Study Director Novartis
PRS Account Novartis
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP