A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)

UCB

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis

Treatments: Drug: Bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03410992

2016-003426-16 (EudraCT Number)

PS0013

Details and patient eligibility

About

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

Enrollment: 435 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be at least 18 years of age
• Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
• 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 is a candidate for systemic PSO therapy and/or phototherapy
• Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion criteria

• Subject has an active infection (except common cold), a recent 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 positive suicide behavior
• Presence of moderately severe major depression or severe major 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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435 participants in 3 patient groups, including a placebo group

Bimekizumab cohort

Experimental group

Description:

Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.

Treatment:

Other: Placebo

Drug: Bimekizumab

Placebo

Placebo Comparator group

Description:

Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.

Treatment:

Other: Placebo

Bimekizumab Escape arm

Experimental group

Description:

Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.

Treatment:

Drug: Bimekizumab