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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
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Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: Bimekizumab


Participation Criteria
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Eligibility Criteria
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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: Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimekizumab dose regimen 1<br>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 | Drug: Bimekizumab<br>* Subjects will receive bimekizumab at pre-specified time-points.<br>* Other names: UCB4940;|
| Experimental: Bimekizumab dose regimen 2<br>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 | Drug: Bimekizumab<br>* Subjects will receive bimekizumab at pre-specified time-points.<br>* Other names: UCB4940;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used. | From Baseline to Safety Follow Up 2 (up to Week 220) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used. | From Baseline to Safety Follow Up 2 (up to Week 220) | 
| 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 is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used. | From Baseline to Safety Follow Up 2 (up to Week 220) | 
| Psoriasis Area Severity Index 90 (PASI90) response at Week 144 | A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score. | Week 144 | 
| Investigator´s Global Assessment (IGA) 0/1 response at Week 144 | The Investigator will assess the overall severity of psoriasis using the following 5-point scale (five-point IGA): 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present) = Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling) = Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling) = Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling) = Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions) | Week 144 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSO, Bimekizumab, Psoriasis