A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Status: | Recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/21/2019 |
Start Date: | June 13, 2018 |
End Date: | August 2020 |
Contact: | UCB Cares |
Email: | UCBCares@ucb.com |
Phone: | +1844599 |
A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with
moderate to severe chronic plaque psoriasis (PSO).
moderate to severe chronic plaque psoriasis (PSO).
Inclusion Criteria:
- Male or female at least 18 years of age
- Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to
the Screening visit
- Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
- Subject must be considered, in the opinion of the Investigator, to be a suitable
candidate for treatment with secukinumab per regional labeling and has no
contraindications to receive secukinumab as per the local label
- 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 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 severe 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
We found this trial at
24
sites
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