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

NCT03230292 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: PS00182016-002934-57
• Study Type: interventional
• Target: 43
• Locations: 4 countries
• Sites: 10

Brief Summary

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

Conditions

Chronic Plaque Psoriasis

Keywords

Psoriasis; Chronic Plaque Psoriasis; Bimekizumab

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment

  TEAEs were events that had a start date on or after the first administration of study treatment in PS0018 until the last received dose of investigational medicinal product (IMP) +140 days \[which covered the 20-week Safety Follow-Up (SFU) Visit\]. The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.

  From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Secondary Outcomes (26)

• Plasma Concentration of Bimekizumab During the Study

  From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

• Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment

  Baseline of study PS0016 [NCT03025542]

• Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment

  From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

• Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study

  From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

• Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study

  From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Study Arms (1)

Cohort 1

EXPERIMENTAL

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

Interventions

Bimekizumab DRUG

Bimekizumab will be administered subcutaneously in 2 different doses.

Also known as: UCB4940

Cohort 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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, Paracoccidioides, 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)

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (10)

Ps0018 701

High Point, North Carolina, 27265, United States

Location

Ps0018 704

Bexley, Ohio, 43209, United States

Location

Ps0018 101

Carlton, Australia

Location

Ps0018 103

East Melbourne, Australia

Location

Ps0018 102

Kogarah, Australia

Location

Ps0018 104

Woolloongabba, Australia

Location

Ps0018 201

Ajax, Canada

Location

Ps0018 203

London, Canada

Location

Ps0018 202

Windsor, Canada

Location

Ps0018 501

Chisinau, Moldova

Location

Related Publications (1)

• Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.

  PMID: 35544084 RESULT

Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  UCB (001 844 599 2273)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: July 3, 2017
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: July 22, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Locations

AU (4); MO (1); US (2); CA (3)