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

• Status: Completed
• Trial end date: 2020-01-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.

Criteria

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