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

• ClinicalTrials.gov Identifier: NCT03230292
• Recruitment Status: Completed
• First Posted: July 26, 2017
• Last Update Posted: July 17, 2020
• Sponsor: UCB Biopharma S.P.R.L.
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Plaque Psoriasis	Drug: Bimekizumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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.
• Actual Study Start Date: July 3, 2017
• Actual Primary Completion Date: March 6, 2019
• Actual Study Completion Date: March 6, 2019

Arms and Interventions

Arm

Intervention/treatment

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.

Drug: Bimekizumab; Bimekizumab will be administered subcutaneously in 2 different doses.; Other Name: UCB4940

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment [ Time Frame: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

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)

Contacts and Locations

Locations

United States, North Carolina

Ps0018 701

High Point, North Carolina, United States, 27265

United States, Ohio

Ps0018 704

Bexley, Ohio, United States, 43209

Australia

Ps0018 101

Carlton, Australia

Ps0018 103

East Melbourne, Australia

Ps0018 102

Kogarah, Australia

Ps0018 104

Woolloongabba, Australia

Canada

Ps0018 201

Ajax, Canada

Ps0018 203

London, Canada

Ps0018 202

Windsor, Canada

Moldova, Republic of

Ps0018 501

Chisinau, Moldova, Republic of

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators

• Study Director: UCB Cares; UCB (+1 844 599 2273)

More Information

• Responsible Party: UCB Biopharma S.P.R.L.
• ClinicalTrials.gov Identifier: NCT03230292
• Other Study ID Numbers: PS0018; 2016-002934-57 ( EudraCT Number )
• First Posted: July 26, 2017
• Last Update Posted: July 17, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):

Psoriasis; Chronic Plaque Psoriasis; Bimekizumab

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases