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

NCT ID: NCT05499416

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-04-30

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).

Detailed Description

This study is being conducted to evaluate the effects of bimekizumab administered subcutaneously (SC) to patients with psoriasis vulgaris and who also have active PsA who have an inadequate skin response to anti-interleukin (IL)23 therapy. Approximately 20 adult subjects with psoriasis vulgaris and active PsA who have an inadequate skin response to anti-IL23 will receive bimekizumab 320 mg solution administered SC every 4 weeks for 16 weeks.

Conditions

Psoriasis Vulgaris; Active Psoriatic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bimekizumab 320 mg SC injections

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

Group Type: EXPERIMENTAL

Bimekizumab

Intervention Type: 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

Interventions

Bimekizumab

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

Intervention Type: DRUG

Other Intervention Names

BIMZELX®

Eligibility Criteria

Inclusion Criteria

1. Male or female patient 18 years of age or older at the time of consent.

2. Patient with a history of psoriasis vulgaris and PsA (as determined by the investigator) for ≥ 6 months prior to the screening visit.

3. Patient with moderate-to-severe psoriasis vulgaris before initiating treatment with an anti-IL23 agent.

4. 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.

5. Patient with active PsA as defined by ≥ 1 joint that is tender (TJC68) and/or swollen (SJC66) at Day 1.

Exclusion Criteria

1. 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.

2. Patient with evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.

3. 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.

4. 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.

5. 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.

6. Patient with a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

7. Patient with known or suspected hypersensitivity to bimekizumab or any component of the investigational product, including any nonmedicinal ingredient, or component of the container.

8. 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.

9. Patient who has received treatment with bimekizumab prior to Day 1.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: collaborator

Innovaderm Research Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bissonnette, MD

Role: PRINCIPAL_INVESTIGATOR

Innovaderm Research Inc.

Other Identifiers

INNO-5031

Identifier Type: -

Identifier Source: org_study_id