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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, Psoriatic Arthritis

In brief

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).

Key facts

Study ID

NCT03370133

Run by

UCB Biopharma SRL

People needed

567

Starts

2017-12-06

Expected to finish

2019-12-13

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ps0009 910 — Bakersfield, California, United States
• Ps0009 919 — San Diego, California, United States
• Ps0009 906 — Boca Raton, Florida, United States
• Ps0009 909 — Boynton Beach, Florida, United States
• Ps0009 912 — Coral Gables, Florida, United States
• Ps0009 907 — Miami, Florida, United States
• Ps0009 903 — Ocala, Florida, United States
• Ps0009 921 — Ormond Beach, Florida, United States
• Ps0009 918 — Tampa, Florida, United States
• Ps0009 941 — Alpharetta, Georgia, United States
• Ps0009 911 — Plainfield, Indiana, United States
• Ps0009 900 — West Des Moines, Iowa, United States
• Ps0009 905 — Overland Park, Kansas, United States
• Ps0009 922 — Baton Rouge, Louisiana, United States
• Ps0009 917 — Troy, Michigan, United States
• Ps0009 915 — St Louis, Missouri, United States
• Ps0009 958 — Omaha, Nebraska, United States
• Ps0009 901 — Portsmouth, New Hampshire, United States
• Ps0009 908 — East Windsor, New Jersey, United States
• Ps0009 923 — Albuquerque, New Mexico, United States
• Ps0009 913 — New York, New York, United States
• Ps0009 920 — Portland, Oregon, United States
• Ps0009 924 — Houston, Texas, United States
• Ps0009 914 — San Antonio, Texas, United States
• Ps0009 946 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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