This is a study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in adult patients with chronic plaque psoriasis.

A multicenter, 48-week, open-label 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

EUCTR2016-002934-57-DE

Enrollment

Registered

2016-11-03

Start date

2017-02-22

Completion date

Unknown

Last updated

2017-03-13

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 must have completed all dosing requirements in PS0016 without meeting any withdrawal criteria - Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives) 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Subjects previously participating in this study - Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study. Note: For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subject’s entry into PS0018 - Subject has any current sign or symptom that may indicate a medically significant infection - Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidiodes, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed. - Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess the long-term safety and tolerability of bimekizumab.;Secondary Objective: - assess the safety and tolerability of increasing the dose of bimekizumab from dose 1 every four weeks (Q4W) to dose 2 Q4W for subjects with an inadequate response at Week 12 - assess pharmacokinetics (PK) of bimekizumab - assess the immunogenicity of bimekizumab - assess the efficacy of open-label bimekizumab dose 1 Q4W administered 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 (Week 0) until Safety Follow Up Visit (up to Week 64)	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess the long-term safety and tolerability of bimekizumab.;Secondary Objective: - assess the safety and tolerability of increasing the dose of bimekizumab from dose 1 every four weeks (Q4W) to dose 2 Q4W for subjects with an inadequate response at Week 12 - assess pharmacokinetics (PK) of bimekizumab - assess the immunogenicity of bimekizumab - assess the efficacy of open-label bimekizumab dose 1 Q4W administered 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 (Week 0) until Safety Follow Up Visit (up to Week 64)

—

Secondary

Measure	Time frame
Secondary end point(s): NAP;Timepoint(s) of evaluation of this end point: NAP	—

Countries

Australia, Canada, Georgia, Germany, Moldova, Republic of, Romania, 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