Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis

Conditions

• Chronic Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bimekizumab — DRUG
  Subjects will be randomized to receive a combination of injections of Bimekizumab.
• Placebo — OTHER
  Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Study Details

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.

Key Dates

Start date

Aug 31, 2016

Status verified

Jul 2022

Primary completion

Jun 30, 2017

Completion

Jul 31, 2017

Study Design

Enrollment

250 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
• Experimental: Bimekizumab dosing regimen 1
• Experimental: Bimekizumab dosing regimen 2
• Experimental: Bimekizumab dosing regimen 3
• Experimental: Bimekizumab dosing regimen 4
• Experimental: Bimekizumab dosing regimen 5

Primary Outcome Measure

Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 [ Time Frame: Week 12 ]

Locations (11)

Find similar trials in Fremont, CA