This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).
The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,353
Subjects will receive bimekizumab at pre-specified time-points.
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time frame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP
The number of SAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk is used.
Time frame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP
The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment were scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time frame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)
The PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the 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 respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Ps0014 957
Glendale, Arizona, United States
Ps0014 946
Phoenix, Arizona, United States
Ps0014 910
Bakersfield, California, United States
Ps0014 927
Los Angeles, California, United States
Ps0014 919
San Diego, California, United States
Ps0014 955
San Diego, California, United States
Ps0014 943
San Luis Obispo, California, United States
Ps0014 967
Santa Monica, California, United States
Ps0014 934
Washington D.C., District of Columbia, United States
Ps0014 909
Boynton Beach, Florida, United States
...and 179 more locations
Time frame: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)
PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the 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 involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum score is 0= no disease, maximum score is 72= maximal disease.
Time frame: Week 144 compared to Baseline of PS0014 for Cohort B
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of clear \[0\] or almost clear \[1\] with at least two category improvement from Baseline at visit timepoint.
Time frame: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of 0 or 1 at Week 144.
Time frame: Week 144 for Cohort B EP and GPP groups