PS0009
PS0009
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis
Brief summary
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).
Medical Condition
Psoriatic Arthritis
Min. Age
18
Years
Max. Age
-
Who Can Join?
All
Status
Active, not recruiting
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
Study Medication Description
Study Medication:
Bimekizumab
Other Descriptive Name:
UCB4940
Placebo
Yes
Comparator:
No
Refer to a friend
Study Dates
December 2017
Actual Start Date of Enrollment
January 2020
Planned Study Completion Date
General Information
Study ID:
PS0009
EudraCT Number:
2016-003425-42
CT.gov Number:
NCT03370133
Phase:
Phase 3