A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3

Completed

Conditions: Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis

Interventions: Drug: Bimekizumab

Registration Number: NCT03598790

Lead Sponsor: UCB Biopharma SRL

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1353

Inclusion Criteria

Treatment Period (open-label)

Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria
Female subjects must be:
1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014

OLE2 Period (USA and Canada)

Completed the OLE Period without meeting any withdrawal criteria
Compliant with ongoing clinical study requirements
Female subject of childbearing potential must be willing to use highly effective method of contraception
Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
Signed a separate OLE2 Period ICF

Exclusion Criteria

Treatment Period (open-label)

Subject has previously participated in this study
Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator
Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen

OLE2 Period (USA and Canada)

Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
Presence of active suicidal ideation or severe depression
Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bimekizumab dose regimen 2	Bimekizumab	Subjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label). Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2. Intervention Name: Bimekizumab
Bimekizumab dose regimen 1	Bimekizumab	Subjects are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48) Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks. Intervention Name: Bimekizumab

Primary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)	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	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.

Secondary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP	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	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.
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP	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	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.
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)	Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B	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.
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)	Week 144 compared to Baseline of PS0014 for Cohort B	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.
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)	Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B	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.
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)	Week 144 for Cohort B EP and GPP groups	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.

Trial Locations

Locations (189): Ps0014 957
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Glendale, Arizona, United States
Ps0014 946
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Phoenix, Arizona, United States
Ps0014 910
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Bakersfield, California, United States
Ps0014 927
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Los Angeles, California, United States
Ps0014 919
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San Diego, California, United States
Ps0014 955
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San Diego, California, United States
Ps0014 943
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San Luis Obispo, California, United States
Ps0014 967
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Santa Monica, California, United States
Ps0014 934
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Washington, District of Columbia, United States
Ps0014 909
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Boynton Beach, Florida, United States
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Ps0014 957
🇺🇸Glendale, Arizona, United States