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

UCB Biopharma SRL743 enrolled

Overview

This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

743

Conditions

Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis

Interventions

BimekizumabDRUG

Subjects will receive bimekizumab at pre-specified time-points.

SecukinumabDRUG

Subjects will receive secukinumab at pre-specified time-points.

PlaceboOTHER

Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Double-blind Treatment Period * Male or female at least 18 years of age * Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit * Subject must have Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5 point scale * Subject must be a candidate for systemic PSO therapy and/or phototherapy * Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label * Female subject of childbearing potential must be willing to use highly effective method of contraception Open-label extension (OLE) Period * Completed the double-blind Treatment Period without meeting any withdrawal criteria * All Week 48 visit assessments completed * Compliant with ongoing clinical study requirements * Signed a separate OLE Period Informed Consent Form (ICF) * Female subject of childbearing potential must be willing to use highly effective method of contraception 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: Double-blind Treatment Period * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study * Presence of active suicidal ideation or severe depression * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer 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

Locations (77)

Outcomes

Primary Outcomes

Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16

The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. 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 the percentage of skin covered with PSO for each of 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Time frame: Week 16

Secondary Outcomes

Percentage of Participants With a PASI75 Response at Week 4

The PASI75 response assessments are based on at least 75% improvement in PASI score from 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 body areas and converting to 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Time frame: Week 4

Percentage of Participants With a PASI90 Response at Week 16

The PASI90 response assessments are based on at least 90% improvement in PASI score from 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.

Data from ClinicalTrials.gov

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