Trial record 1 of 1 for:
NCT02969525
A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis (BE ACTIVE)
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ClinicalTrials.gov Identifier: NCT02969525 |
Recruitment Status :
Completed
First Posted : November 21, 2016
Results First Posted : November 25, 2020
Last Update Posted : November 25, 2020
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Sponsor:
UCB Biopharma S.P.R.L.
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Psoriatic Arthritis |
Interventions |
Other: Placebo Drug: Bimekizumab |
Enrollment | 206 |
Participant Flow
Recruitment Details | The study started to enroll patients in October 2016 and concluded in July 2018. |
Pre-assignment Details |
The study included a 28-Day Screening Period, followed by a Double-blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post week 48. The Participant Flow refers to the Randomized Set and Dose-Blind Set. |
Arm/Group Title | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Placebo - BKZ 160 mg | Placebo - BZK 320 mg | BKZ 16 mg - BKZ 160 mg | BZK 16 mg - BZK 320 mg | BZK 160 mg LD - BZK 160 mg | BZK 160 mg - BKZ Dose 160 mg | BKZ 320 mg - BKZ 320 mg |
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Participants received Placebo during the 12 Weeks Double-Blind Period. | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period. | Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. | Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period. | After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period. | After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period. | After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. | After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. | After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. | After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. | After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. |
Period Title: Double-Blind Period | ||||||||||||
Started | 42 | 41 | 41 | 41 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Completed Double-Blind Period | 42 | 41 | 40 | 39 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Completed Wk12 and Started Dose-Blind | 40 | 41 | 40 | 37 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Completed | 40 | 41 | 40 | 37 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Not Completed | 2 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Reason Not Completed | ||||||||||||
Adverse Event | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
LOW EGFR | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Study medication discontinued prior Wk12 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Dose-Blind Period | ||||||||||||
Started | 0 | 0 | 0 | 0 | 0 | 20 | 20 | 22 | 19 | 37 | 40 | 41 |
Completed | 0 | 0 | 0 | 0 | 0 | 20 | 18 | 22 | 18 | 34 | 38 | 39 |
Not Completed | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 3 | 2 | 2 |
Reason Not Completed | ||||||||||||
Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | 0 |
Non-cooperating patient | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Withdrew before Safety Follow-up visit | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Total Title | |
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Participants received Placebo during the 12 Weeks Double-Blind Period. | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period. | Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period. | Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period. | [Not Specified] | |
Overall Number of Baseline Participants | 42 | 41 | 41 | 41 | 41 | 206 | |
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The Baseline Characteristics refer to the Full Analysis Set (FAS), which consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 41 participants | 41 participants | 41 participants | 41 participants | 206 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
38 90.5%
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35 85.4%
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40 97.6%
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36 87.8%
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36 87.8%
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185 89.8%
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>=65 years |
4 9.5%
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6 14.6%
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1 2.4%
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5 12.2%
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5 12.2%
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21 10.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 42 participants | 41 participants | 41 participants | 41 participants | 41 participants | 206 participants | |
49.02 (12.07) | 49.98 (13.56) | 48.00 (11.65) | 49.05 (12.99) | 50.39 (12.08) | 49.29 (12.39) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 41 participants | 41 participants | 41 participants | 41 participants | 206 participants | |
Female |
18 42.9%
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17 41.5%
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21 51.2%
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27 65.9%
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18 43.9%
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101 49.0%
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Male |
24 57.1%
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24 58.5%
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20 48.8%
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14 34.1%
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23 56.1%
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105 51.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 41 participants | 41 participants | 41 participants | 41 participants | 206 participants | |
Asian |
1 2.4%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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1 0.5%
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Black |
1 2.4%
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1 2.4%
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2 4.9%
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1 2.4%
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0 0.0%
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5 2.4%
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White |
40 95.2%
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40 97.6%
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39 95.1%
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40 97.6%
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41 100.0%
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200 97.1%
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