Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis

NCT05499416 | Withdrawn Phase 4

• 1 other identifier: INNO-5031
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label study to evaluate the effects of bimekizumab in patients with psoriasis vulgaris and who also have active psoriatic arthritis (PsA).

Conditions

Psoriasis Vulgaris; Active Psoriatic Arthritis

Keywords

plaque psoriasis; systemic therapy; psoriasis vulgaris; arthritic psoriasis; bimekizumab

Outcome Measures

Primary Outcomes (2)

• Physician Global Assessment (PGA) x Body Surface Area (BSA)

  The product of physician's global assessment and body surface area (PGA×BSA) is a measure of psoriasis severity (0-400), with higher scores indicating more severe disease.

  Week 24

• Proportion of patients achieving MDA

  A patient will be considered to have achieved MDA when meeting 5/7 of the following criteria: tender joints count ≤ 1; swollen joints count ≤ 1; Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%; patient pain visual analog scale (VAS) ≤ 15 mm; patient's global assessment of arthritis visual analog scale (PtGA VAS) ≤ 20 mm; Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5; tender entheseal points ≤ 1.

  Week 24

Secondary Outcomes (15)

• Physician Global Assessment (PGA)

  Weeks 12 and 24

• Body Surface Area (BSA)

  Weeks 12 and 24

• Psoriasis Area and Severity Index (PASI)

  Weeks 12 and 24

• American College of Rheumatology (ACR)

  Week 24

• Tender joints count (TJC)

  Week 24

Study Arms (1)

Bimekizumab 320 mg SC injections

EXPERIMENTAL

Bimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks.

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

Self-administration of two (2-160 mg/mL \[1 mL\]) pre-filled syringes or autoinjectors at baseline (Day1) and at Weeks 4, 8,12, and 16

Also known as: BIMZELX®

Bimekizumab 320 mg SC injections

Eligibility Criteria

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

You may qualify if:

• Male or female patient 18 years of age or older at the time of consent.
• Patient with a history of psoriasis vulgaris and PsA (as determined by the investigator) for ≥ 6 months prior to the screening visit.
• Patient with moderate-to-severe psoriasis vulgaris before initiating treatment with an anti-IL23 agent.
• Patient with an inadequate skin response to at least 12 weeks treatment with an anti-IL23 agent for the treatment of psoriasis vulgaris as defined by a PGA ≥ 2 and plaque psoriasis covering ≥ 1% of total BSA (excluding palms and soles) at the screening and Day 1 visits.
• Patient with active PsA as defined by ≥ 1 joint that is tender (TJC68) and/or swollen (SJC66) at Day 1.

You may not qualify if:

• Female who is breastfeeding, pregnant, or who is planning to become pregnant during the study or within 4 months after the last study product administration.
• Patient with evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.
• Patient with any known clinically significant medical condition or presence of a skin or rheumatologic disease that would, in the opinion of the investigator, put the patient at undue risk or interfere with the interpretation of study results.
• Patient who plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives (of the study product), whichever is longer, after the last study product administration.
• Patient with an active infection (except common cold) that would place them at increased risk, a recent serious infection, or a history of opportunistic, recurrent, or chronic infections.
• Patient with a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• Patient with known or suspected hypersensitivity to bimekizumab or any component of the investigational product, including any nonmedicinal ingredient, or component of the container.
• Patient who has received any marketed or investigational biological agent, except anti-IL23 agents, within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
• Patient who has received treatment with bimekizumab prior to Day 1.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Ciusss de L'Est de l'Île de Montréal: collaborator

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 12, 2022
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: April 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share