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

• Register: EUCTR
• Last refreshed on: 13 March 2017
• Main ID: EUCTR2016-002934-57-DE
• Date of registration: 03/11/2016
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SPRL
• Public title: This is a study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in adult patients with chronic plaque psoriasis.
• Scientific title: 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.
• Date of first enrolment: 22/02/2017
• Target sample size: 45
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002934-57
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

Key inclusion & exclusion 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:
- 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-

Primary Outcome(s)

Primary end point(s): Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment

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

Timepoint(s) of evaluation of this end point: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NAP

Secondary end point(s): NAP

Secondary ID(s)

PS0018

Source(s) of Monetary Support

UCB Biopharma SPRL