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

Conditions

• Chronic Plaque Psoriasis
• Moderate to Severe Chronic Plaque Psoriasis
• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bimekizumab — DRUG
  Bimekizumab will be provided at pre-specified time intervals.
• Placebo — OTHER
  Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Study Details

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

Key Dates

Start date

Feb 5, 2018

Status verified

Apr 2026

Primary completion

Dec 28, 2018

Completion

Jan 7, 2020

Study Design

Enrollment

435 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bimekizumab cohort
  Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.
• Placebo Comparator: Placebo
  Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.
• Experimental: Bimekizumab Escape arm
  Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.

Primary Outcome Measure

Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 [ Time Frame: At Week 16 ]

Locations (20)

Find similar trials in San Diego, CA

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