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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psoriasis Vulgaris, Active Psoriatic Arthritis

Intervention / Treatment
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* Drug: Bimekizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimekizumab 320 mg SC injections<br>Bimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks. | Drug: Bimekizumab<br>* 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<br>* Other names: BIMZELX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body Surface Area (BSA) | The overall BSA affected by psoriasis vulgaris will be evaluated (from 0% to 100%). | Weeks 12 and 24 | 
| 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 | 
| 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 | 
| Tender joints count (TJC) | The tenderness of 68 joints (TJC68) will be assessed and the counts recorded. | Week 24 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Dactylitis Count | Dactylitis is characterized by diffuse swelling of a finger and/or toe. | Week 24 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque psoriasis, systemic therapy, psoriasis vulgaris, arthritic psoriasis, bimekizumab