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Sponsor decision.
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| Name | Class |
|---|---|
| Ciusss de L'Est de l'Île de Montréal | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab 320 mg SC injections | Experimental | Bimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD | Innovaderm Research Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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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 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |