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

UCB

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Plaque Psoriasis

Treatments: Drug: Bimekizumab; Drug: Adalimumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03412747

2016-003392-22 (EudraCT Number)

PS0008

Details and patient eligibility

About

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

Enrollment: 478 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be at least 18 years of age
• Chronic plaque 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 a known hypersensitivity to any excipients of bimekizumab or adalimumab
• Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent 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
• Subject has had previous exposure to adalimumab
• 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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478 participants in 3 patient groups

Bimekizumab Arm 1

Experimental group

Description:

Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Treatment:

Other: Placebo

Drug: Bimekizumab

Bimekizumab Arm 2

Experimental group

Description:

Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Treatment:

Other: Placebo

Drug: Bimekizumab

Adalimumab Arm

Active Comparator group

Description:

Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Treatment:

Other: Placebo

Drug: Adalimumab

Drug: Bimekizumab