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

Psoriasis Vulgaris Clinical Trial

Official title:

Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05499416
• Other study ID #: INNO-5031
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Innovaderm Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Active Psoriatic Arthritis
• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Innovaderm Research Inc.	Ciusss de L'Est de l'Île de Montréal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Physician Global Assessment (PGA)	The PGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity, with higher scores indicating more severe disease.	Weeks 12 and 24
Secondary	Body Surface Area (BSA)	The overall BSA affected by psoriasis vulgaris will be evaluated (from 0% to 100%).	Weeks 12 and 24
Secondary	Psoriasis Area and Severity Index (PASI)	The PASI is a composite score that considers the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of 4 body regions.	Weeks 12 and 24
Secondary	American College of Rheumatology (ACR)	The ACR is a composite including the number of tender and number of swollen joints, patient's global assessment of arthritis visual analog scale (PtGA VAS), physician global assessment visual analog scale (MDGA VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient pain visual analog scale (VAS), and C-reactive protein (CRP) levels. The proportion of patients achieving ACR20, ACR50, and ACR70 will be calculated.	Week 24
Secondary	Tender joints count (TJC)	The tenderness of 68 joints (TJC68) will be assessed and the counts recorded.	Week 24
Secondary	Swollen joints count (SJC)	The level of swelling at 66 joints (SJC66) will be assessed and the counts recorded. The swollen joints count can range between 0 and 66 and represents the sum of the total number of swollen joints.	Week 24
Secondary	Physician's Global Assessment of Arthritis Visual Analogue Scale (MDGA VAS)	The physician's global assessment of disease activity will be measured using 100-mm VAS scale with anchor statements on the left (none) and on the right (extremely active).	Week 24
Secondary	Patient's Assessment of Arthritis Pain Visual Analogue Scale (patient pain VAS)	The patient's assessment of pain will be measured using 100-mm VAS scale with anchor statements on the left (no pain) and on the right.	Week 24
Secondary	Patient's Global Assessment of Arthritis Visual Analogue Scale (PtGA VAS)	The patient's global assessment of disease activity will be measured using 100-mm VAS scale with anchor statements on the left (very well) and on the right (very poorly).	Week 24
Secondary	Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)	The SPARCC Enthesitis Index is a composite score that quantifies the extent of tenderness at 16 sites on a dichotomous basis.	Week 24
Secondary	Leeds Enthesitis Index (LEI)	The LEI is an enthesitis index that involves evaluation of tenderness at 6 examination points/sites bilaterally. The LEI score can range between 0 and 6, with higher scores indicating more enthesis sites.	Week 24
Secondary	Dactylitis Count	Dactylitis is characterized by diffuse swelling of a finger and/or toe.	Week 24
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	The BASDAI is a self-administered instrument that measures severity of fatigue/tiredness, spinal and peripheral joint pain, localized tenderness, and morning stiffness. The BASDAI score can range between 0 and 10, with higher scores indicating worse disease control.	Weeks 12 and 24
Secondary	Health Assessment Questionnaire-Disability Index (HAQ-DI)	The HAQ-DI is a patient questionnaire that evaluates the degree of disability and pain index over the past week. The HAQ-DI score can range between 0 and 3, with higher scores indicating more disability and pain.	Weeks 12 and 24
Secondary	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	The FACIT-F is a 13-item measure, which be used to assess fatigue and its impact on daily activities and function in the past 7 days. The FACIT-F score can range between 0 and 52, with higher scores indicating less fatigue.	Weeks 12 and 24