A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

Conditions

• Chronic Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Bimekizumab — DRUG
  Bimekizumab will be administered subcutaneously in 2 different doses.

Study Details

This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.

Key Dates

Start date

Jul 3, 2017

Status verified

Mar 2022

Primary completion

Mar 6, 2019

Completion

Mar 6, 2019

Study Design

Enrollment

43 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Subjects in this cohort will receive dose 1 every four weeks (Q4W) subcutaneously (sc) during the 48-week open-label Treatment Period. There will be an option to increase the dose to dose 2 Q4W at the discretion of the Investigator if the subject's Psoriasis Area and Severity Index (PASI) response is \>=50% to \<75% reduction from the Baseline of PS0016 at Week 12 or later. If the subject's disease is adequately controlled on dose 2 Q4W, they may return to dose 1 Q4W at the discretion of the Investigator.

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment [ Time Frame: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64) ]

Locations (2)

Find similar trials in High Point, NC