Status:
COMPLETED
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
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2020
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT03410992
Start Date
February 5 2018
End Date
January 7 2020
Last Update
December 23 2025
Active Locations (77)
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1
Ps0013 919
San Diego, California, United States, 92103
2
Ps0013 955
San Diego, California, United States, 92123
3
Ps0013 967
Santa Monica, California, United States, 90404
4
Ps0013 928
Fort Myers, Florida, United States, 33912