Study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in patients with chronic plaque psoriasis.

A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001892-57-HU

Enrollment

240

Registered

2016-09-21

Start date

2016-11-08

Completion date

Unknown

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic plaque psoriasis MedDRA version: 19.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Product Name: Bimekizumab Product Code: UCB4940 Pharmaceutical Form: Solution for injection INN or Proposed INN: Bimekizumab CAS Number: 1418205-77-2 Other descriptive name: UCB4940 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject has provided informed consent. - Subject completes all dosing requirements in feeder study and completes PS0010 without meeting any withdrawal criteria. - Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Subject has previously participated in this study. - Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose. - Subject has any medical of psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject´s ability to participate in this study. - Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the long-term safety and tolerability of bimekizumab.;Secondary Objective: Assess the efficacy of bimekizumab administered every 4 weeks (Q4W) over 48 weeks.;Primary end point(s): Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment;Timepoint(s) of evaluation of this end point: From Baseline until Safety Follow Up Visit (up to Week 64)	—

Measure

Time frame

Main Objective: Assess the long-term safety and tolerability of bimekizumab.;Secondary Objective: Assess the efficacy of bimekizumab administered every 4 weeks (Q4W) over 48 weeks.;Primary end point(s): Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment;Timepoint(s) of evaluation of this end point: From Baseline until Safety Follow Up Visit (up to Week 64)

—

Secondary

Measure	Time frame
Secondary end point(s): - Change from Baseline in Psoriasis Area Severity Index (PAS190) response over time - Change from Baseline in Investigator´s Global Assessment over time;Timepoint(s) of evaluation of this end point: From Baseline during the Treatment Period (up to Week 48)	—

Countries

Canada, Czech Republic, Hungary, Japan, Poland, United States

Contacts

Public ContactClin Trial Reg & Results Disclosure

UCB Biosciences GmbH

clinicaltrials@ucb.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026