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Trial record 1 of 1 for:    PA0009
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A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis (BE ACTIVE 2)

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ClinicalTrials.gov Identifier: NCT03347110
Recruitment Status : Completed
First Posted : November 20, 2017
Results First Posted : December 1, 2023
Last Update Posted : December 1, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Intervention Drug: Bimekizumab
Enrollment 184
Recruitment Details The study started to enroll study participants in November 2017 and concluded in October 2020.
Pre-assignment Details Participant Flow refers to the Safety Set. Participants who completed the study PA0008 (NCT02969525) were eligible to enroll in study PA0009. A total of 184 participants from PA0008 signed the Informed Consent Form and were enrolled in PA0009 study. Among 184 participants, 1 participant did not receive treatment and was not included in analysis.
Arm/Group Title Bimekizumab 160 mg
Hide Arm/Group Description Participants received bimekizumab (BKZ) 160 milligrams (mg) as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 100 weeks.
Period Title: Overall Study
Started 183
Completed 161
Not Completed 22
Reason Not Completed
Other (Participant is incarcerated)             1
Withdrawal by Subject             9
Lost to Follow-up             1
Lack of Efficacy             2
Adverse Event, non-fatal             9
Arm/Group Title Bimekizumab 160 mg (SS)
Hide Arm/Group Description Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the Safety Set (SS) which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Overall Number of Baseline Participants 183
Hide Baseline Analysis Population Description
Baseline Characteristics refer to SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants
<=18 years
0
   0.0%
Between 18 and 65 years
165
  90.2%
>=65 years
18
   9.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 183 participants
49.0  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants
Female
87
  47.5%
Male
96
  52.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants
Black
4
   2.2%
White
179
  97.8%
1.Primary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as events with onset date on or after the start date of study medication in PA0009.
Time Frame From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Arm/Group Title Bimekizumab 160 mg (SS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Overall Number of Participants Analyzed 183
Measure Type: Number
Unit of Measure: percentage of participants
80.9
2.Primary Outcome
Title Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
Hide Description A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.
Time Frame From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Arm/Group Title Bimekizumab 160 mg (SS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Overall Number of Participants Analyzed 183
Measure Type: Number
Unit of Measure: percentage of participants
7.7
3.Secondary Outcome
Title Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study
Hide Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Arm/Group Title Bimekizumab 160 mg (SS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Overall Number of Participants Analyzed 183
Measure Type: Number
Unit of Measure: percentage of participants
4.9
4.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008
Hide Description The ACR20 response rate was based on 20% or greater improvement relative to Baseline of PA0008 in the following measures: Tender Joint Count (TJC) based on 78 joints, Swollen Joint Count (SJC) based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA), Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA), Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP), Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI), Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP). Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.
Time Frame Baseline of PA0008, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Arm/Group Title Bimekizumab 160 mg (FAS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the Full Analysis Set (FAS) which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: percentage of participants
79.0
5.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008
Hide Description The ACR50 response rate was based on 50% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.
Time Frame Baseline of PA0008, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Arm/Group Title Bimekizumab 160 mg (FAS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the FAS which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: percentage of participants
64.6
6.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008
Hide Description The ACR70 response rate was based on 70% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.
Time Frame Baseline of PA0008, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Arm/Group Title Bimekizumab 160 mg (FAS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the FAS which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: percentage of participants
47.5
7.Secondary Outcome
Title Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 Calculated Relative to Baseline of PA0008
Hide Description The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process). Each item was scored as 0 = not tender or 1 = tender and then were summed for a possible score of 0 to 13, with higher scores indicating worse enthesitis. If 7 or more items were available, MASES was calculated by dividing the summed score with the number of assessments and multiplying the result by 13. If less than 7 items were available, MASES was treated as missing.
Time Frame Baseline of PA0008, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of study participants in the FAS with Enthesitis at PA0008 Baseline (MASES>0).
Arm/Group Title Bimekizumab 160 mg (FAS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the FAS which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Overall Number of Participants Analyzed 95
Mean (Standard Error)
Unit of Measure: score on a scale
-2.99  (0.33)
8.Secondary Outcome
Title Change From Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 Calculated Relative to Baseline of PA0008
Hide Description Presence of dactylitis was assessed using the LDI basic which evaluated for a greater than or equal to (>=) 10% difference in the circumference of the digit compared to the opposite digit and was then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present). The results from each digit with dactylitis were summed to produce a final score. For the final score, the minimum value for LDI is zero and there is no maximum value. A low score indicates less dactylitis symptoms. A score of zero is considered dactylitis free. Observed values have been reported in this outcome measure.
Time Frame Baseline of PA0008, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of study participants in the FAS with Dactylitis at PA0008 Baseline (LDI>0).
Arm/Group Title Bimekizumab 160 mg (FAS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the FAS which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: score on a scale
-54.31  (67.09)
9.Secondary Outcome
Title Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 Calculated Relative to Baseline of PA0008
Hide Description The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with psoriasis (PSO) for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the Final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using least observation carried forward (LOCF) for any visits where the corresponding BSA has not increased compared to the preceding visit.
Time Frame Baseline of PA0008, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of study participants in FAS with body surface area (BSA) affected by psoriasis of >=3% at PA0008 Baseline.
Arm/Group Title Bimekizumab 160 mg (FAS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the FAS which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: percentage of participants
90.0
10.Secondary Outcome
Title Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 Calculated Relative to Baseline of PA0008
Hide Description The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using LOCF for any visits where the corresponding BSA has not increased compared to the preceding visit.
Time Frame Baseline of PA0008, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of study participants in FAS with BSA affected by psoriasis of >=3% at PA0008 Baseline.
Arm/Group Title Bimekizumab 160 mg (FAS)
Hide Arm/Group Description:
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the FAS which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: percentage of participants
80.0
Time Frame From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Adverse Event Reporting Description A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
 
Arm/Group Title Bimekizumab 160 mg (SS)
Hide Arm/Group Description Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
All-Cause Mortality
Bimekizumab 160 mg (SS)
Affected / at Risk (%)
Total   0/183 (0.00%)    
Hide Serious Adverse Events
Bimekizumab 160 mg (SS)
Affected / at Risk (%) # Events
Total   14/183 (7.65%)    
Gastrointestinal disorders   
Anal fistula * 1  1/183 (0.55%)  1
Inguinal hernia * 1  1/183 (0.55%)  1
Umbilical hernia * 1  1/183 (0.55%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  2/183 (1.09%)  2
Infections and infestations   
Chronic sinusitis * 1  1/183 (0.55%)  1
Injury, poisoning and procedural complications   
Meniscus injury * 1  1/183 (0.55%)  1
Ligament rupture * 1  1/183 (0.55%)  1
Musculoskeletal and connective tissue disorders   
Osteochondrosis * 1  1/183 (0.55%)  1
Foot deformity * 1  2/183 (1.09%)  2
Pregnancy, puerperium and perinatal conditions   
Pregnancy on contraceptive * 1  1/183 (0.55%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  1/183 (0.55%)  1
Reproductive system and breast disorders   
Ovarian cyst * 1  1/183 (0.55%)  1
Uterine polyp * 1  1/183 (0.55%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal turbinate hypertrophy * 1  1/183 (0.55%)  1
Nasal septum deviation * 1  1/183 (0.55%)  1
Skin and subcutaneous tissue disorders   
Dermal cyst * 1  1/183 (0.55%)  1
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimekizumab 160 mg (SS)
Affected / at Risk (%) # Events
Total   82/183 (44.81%)    
Infections and infestations   
Oral candidiasis * 1  13/183 (7.10%)  23
Bronchitis * 1  11/183 (6.01%)  15
Upper respiratory tract infection * 1  20/183 (10.93%)  29
Nasopharyngitis * 1  19/183 (10.38%)  24
Pharyngitis * 1  10/183 (5.46%)  11
Sinusitis * 1  10/183 (5.46%)  10
Musculoskeletal and connective tissue disorders   
Psoriatic arthropathy * 1  12/183 (6.56%)  13
Skin and subcutaneous tissue disorders   
Psoriasis * 1  14/183 (7.65%)  15
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1-844-599-2273
EMail: UCBCares@ucb.com
Publications of Results:
Mease PJ, Asahina A, Gladman DD, Tanaka Y, Tillett W, Ink B, Assudani D, de la Loge C, Coarse J, Eells J, Gossec L. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford). 2023 Feb 1;62(2):617-628. doi: 10.1093/rheumatology/keac353.
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03347110    
Other Study ID Numbers: PA0009
2017-001003-74 ( EudraCT Number )
First Submitted: November 15, 2017
First Posted: November 20, 2017
Results First Submitted: October 26, 2023
Results First Posted: December 1, 2023
Last Update Posted: December 1, 2023