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

UCB

Status and phase: Completed; Phase 3

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

Treatments: Drug: Ustekinumab; Drug: Bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03370133

PS0009

2016-003425-42 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 567 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 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
• 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

---

567 participants in 3 patient groups, including a placebo group

Bimekizumab cohort

Experimental group

Description:

Subjects will receive bimekizumab for 52 weeks.

Treatment:

Drug: Bimekizumab

Ustekinumab cohort

Active Comparator group

Description:

Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.

Treatment:

Other: Placebo

Drug: Ustekinumab

Placebo

Placebo Comparator group

Description:

Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.

Treatment:

Other: Placebo

Drug: Bimekizumab