A Study 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bimekizumab — DRUG
  Subjects will receive bimekizumab at pre-specified time-points.

Study Details

This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).

Key Dates

Start date

Sep 5, 2018

Status verified

Apr 2026

Primary completion

Nov 14, 2023

Completion

Nov 14, 2023

Study Design

Enrollment

1,353 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bimekizumab dose regimen 1
  Subjects are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48) Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks. Intervention Name: Bimekizumab
• Experimental: Bimekizumab dose regimen 2
  Subjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label). Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2. Intervention Name: Bimekizumab

Primary Outcome Measure

Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) [ Time Frame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period ]

Locations (48)

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