Back to resultsEffect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis
Primary Purpose
Psoriasis Vulgaris, Active Psoriatic Arthritis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bimekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring plaque psoriasis, systemic therapy, psoriasis vulgaris, arthritic psoriasis, bimekizumab
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bimekizumab 320 mg SC injections
Arm Description
Bimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Body Surface Area (BSA)
The overall BSA affected by psoriasis vulgaris will be evaluated (from 0% to 100%).
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.
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.
Tender joints count (TJC)
The tenderness of 68 joints (TJC68) will be assessed and the counts recorded.
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.
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).
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.
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).
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.
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.
Dactylitis Count
Dactylitis is characterized by diffuse swelling of a finger and/or toe.
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.
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.
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.
Full Information
NCT ID
NCT05499416
First Posted
August 3, 2022
Last Updated
March 13, 2023
Sponsor
Innovaderm Research Inc.
Collaborators
Ciusss de L'Est de l'Île de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT05499416
Brief Title
Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis
Official Title
Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision.
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovaderm Research Inc.
Collaborators
Ciusss de L'Est de l'Île de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, Active Psoriatic Arthritis
Keywords
plaque psoriasis, systemic therapy, psoriasis vulgaris, arthritic psoriasis, bimekizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab 320 mg SC injections
Arm Type
Experimental
Arm Description
Bimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
BIMZELX®
Intervention Description
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
Primary Outcome Measure Information:
Title
Physician Global Assessment (PGA) x Body Surface Area (BSA)
Description
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.
Time Frame
Week 24
Title
Proportion of patients achieving MDA
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Physician Global Assessment (PGA)
Description
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.
Time Frame
Weeks 12 and 24
Title
Body Surface Area (BSA)
Description
The overall BSA affected by psoriasis vulgaris will be evaluated (from 0% to 100%).
Time Frame
Weeks 12 and 24
Title
Psoriasis Area and Severity Index (PASI)
Description
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.
Time Frame
Weeks 12 and 24
Title
American College of Rheumatology (ACR)
Description
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.
Time Frame
Week 24
Title
Tender joints count (TJC)
Description
The tenderness of 68 joints (TJC68) will be assessed and the counts recorded.
Time Frame
Week 24
Title
Swollen joints count (SJC)
Description
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.
Time Frame
Week 24
Title
Physician's Global Assessment of Arthritis Visual Analogue Scale (MDGA VAS)
Description
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).
Time Frame
Week 24
Title
Patient's Assessment of Arthritis Pain Visual Analogue Scale (patient pain VAS)
Description
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.
Time Frame
Week 24
Title
Patient's Global Assessment of Arthritis Visual Analogue Scale (PtGA VAS)
Description
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).
Time Frame
Week 24
Title
Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)
Description
The SPARCC Enthesitis Index is a composite score that quantifies the extent of tenderness at 16 sites on a dichotomous basis.
Time Frame
Week 24
Title
Leeds Enthesitis Index (LEI)
Description
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.
Time Frame
Week 24
Title
Dactylitis Count
Description
Dactylitis is characterized by diffuse swelling of a finger and/or toe.
Time Frame
Week 24
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
Weeks 12 and 24
Title
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
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.
Time Frame
Weeks 12 and 24
Title
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Description
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.
Time Frame
Weeks 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Innovaderm Research Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis
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