Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/30/2018 |
Start Date: | August 2016 |
End Date: | July 2017 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled,
parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics
(PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with
moderate to severe chronic plaque psoriasis in order to guide the selection of doses and
clinical indices in the Phase 3 development program.
parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics
(PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with
moderate to severe chronic plaque psoriasis in order to guide the selection of doses and
clinical indices in the Phase 3 development program.
Inclusion Criteria:
- Subject has provided informed consent
- Chronic plaque psoriasis for at least 6 months prior to Screening
- PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and
IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
potential, must be willing to use a highly effective method of contraception up till
20 weeks after last administration of study drug
- Male subjects with a partner of childbearing potential must be willing to use a condom
when sexually active, up till 20 weeks after the last administration of study
medication
Exclusion Criteria:
- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced
psoriasis
- Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological,
endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
- Subject has any significant concurrent medical condition or laboratory abnormalities,
as defined in the study protocol
- Subject taking prohibited psoriatic medications
- Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects
receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug
administration
- Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17)
therapy or has been exposed to more than 1 biological response modifier (limited to
anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis
prior to the Baseline
- Subject has any current sign or symptom that may indicate an active infection (except
for common cold)
We found this trial at
11
sites
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