Back to resultsA Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE COMPLETE)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, PsA, Bimekizumab
Eligibility Criteria
Inclusion Criteria:
- Subject is male or female at least 18 years of age
- Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
- Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
- Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
- Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
- Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
- Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
- Subject has an active infection or a history of recent serious infections
- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
- Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
- Subject had acute anterior uveitis within 6 weeks of Baseline
- Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
- Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
- Presence of active suicidal ideation, or moderately severe major depression or severe major depression
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Sites / Locations
- Pa0011 50017
- Pa0011 50035
- Pa0011 50004
- Pa0011 50033
- Pa0011 50037
- Pa0011 50039
- Pa0011 50024
- Pa0011 50028
- Pa0011 50023
- Pa0011 50015
- Pa0011 50026
- Pa0011 50047
- Pa0011 50019
- Pa0011 50001
- Pa0011 50016
- Pa0011 50005
- Pa0011 50029
- Pa0011 50010
- Pa0011 50011
- Pa0011 50034
- Pa0011 50125
- Pa0011 50031
- Pa0011 50040
- Pa0011 50020
- Pa0011 50064
- Pa0011 50006
- Pa0011 50008
- Pa0011 50007
- Pa0011 50021
- Pa0011 50012
- Pa0011 50002
- Pa0011 50048
- Pa0011 50036
- Pa0011 50148
- Pa0011 50009
- Pa0011 50027
- Pa0011 50050
- Pa0011 30005
- Pa0011 30002
- Pa0011 30001
- Pa0011 30007
- Pa0011 30006
- Pa0011 50041
- Pa0011 50042
- Pa0011 50043
- Pa0011 50045
- Pa0011 50044
- Pa0011 40009
- Pa0011 40066
- Pa0011 40063
- Pa0011 40012
- Pa0011 40074
- Pa0011 40025
- Pa0011 40028
- Pa0011 40076
- Pa0011 40023
- Pa0011 40117
- Pa0011 40029
- Pa0011 40071
- Pa0011 40027
- Pa0011 40078
- Pa0011 40348
- Pa0011 40075
- Pa0011 40026
- Pa0011 40083
- Pa0011 40030
- Pa0011 40082
- Pa0011 40079
- Pa0011 40084
- Pa0011 40087
- Pa0011 40085
- Pa0011 40086
- Pa0011 20039
- Pa0011 20043
- Pa0011 20036
- Pa0011 20045
- Pa0011 20049
- Pa0011 20044
- Pa0011 20033
- Pa0011 20038
- Pa0011 20041
- Pa0011 20046
- Pa0011 20048
- Pa0011 20031
- Pa0011 20042
- Pa0011 20032
- Pa0011 20030
- Pa0011 40119
- Pa0011 40038
- Pa0011 40037
- Pa0011 40091
- Pa0011 40044
- Pa0011 40090
- Pa0011 40118
- Pa0011 40041
- Pa0011 40097
- Pa0011 40098
- Pa0011 40039
- Pa0011 40043
- Pa0011 20002
- Pa0011 20005
- Pa0011 20010
- Pa0011 20013
- Pa0011 20001
- Pa0011 20004
- Pa0011 20009
- Pa0011 20007
- Pa0011 20014
- Pa0011 20006
- Pa0011 20008
- Pa0011 20015
- Pa0011 40111
- Pa0011 40112
- Pa0011 40109
- Pa0011 40108
- Pa0011 40116
- Pa0011 40107
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bimekizumab dosage regimen
Placebo
Arm Description
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
Subjects randomized to this arm will receive placebo.
Outcomes
Primary Outcome Measures
American College of Rheumatology (ACR) 50 response at Week 16
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
Secondary Outcome Measures
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.
Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16
There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Minimal Disease Activity (MDA) at Week 16
Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA).
A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count <=1, 2) Swollen joint count <=1, 3) PASI <=1 or BSA <=3; 4) Patient pain Visual Analog Scale (VAS) <=15, 5) Patient global activity VAS <=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) <=0.5 and 7) Tender enthesial points <=1.
American College of Rheumatology (ACR) 20 response at Week 16
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.
American College of Rheumatology (ACR) 70 response at Week 16
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
The PsAID-12 total score is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.
Incidence of treatment-emergent adverse events (TEAEs) during the study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of treatment-emergent serious adverse events (SAEs) during the study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03896581
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Acronym
BE COMPLETE
Official Title
A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
February 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, PsA, Bimekizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab dosage regimen
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to this arm will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
BKZ, UCB4940
Intervention Description
Subjects will receive bimekizumab at pre-specified time-points.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Subjects will receive placebo at pre-specified time-points.
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 50 response at Week 16
Description
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
Description
HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.
Time Frame
Baseline, Week 16
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
Description
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Time Frame
Baseline, Week 4
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
Description
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Time Frame
Baseline, Week 16
Title
Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16
Description
There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Time Frame
Baseline, Week 16
Title
Minimal Disease Activity (MDA) at Week 16
Description
Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA).
A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count <=1, 2) Swollen joint count <=1, 3) PASI <=1 or BSA <=3; 4) Patient pain Visual Analog Scale (VAS) <=15, 5) Patient global activity VAS <=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) <=0.5 and 7) Tender enthesial points <=1.
Time Frame
Week 16
Title
American College of Rheumatology (ACR) 20 response at Week 16
Description
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.
Time Frame
Week 16
Title
American College of Rheumatology (ACR) 70 response at Week 16
Description
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.
Time Frame
Week 16
Title
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
Description
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Time Frame
Baseline, Week 4
Title
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
Description
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Time Frame
Baseline, Week 16
Title
Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
Description
The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."
Time Frame
Baseline, Week 16
Title
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
Description
The PsAID-12 total score is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.
Time Frame
Baseline, Week 16
Title
Incidence of treatment-emergent adverse events (TEAEs) during the study
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
From Baseline until Safety Follow-Up (up to Week 36)
Title
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Description
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline until Safety Follow-Up (up to Week 36)
Title
Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
From Baseline until Safety Follow-Up (up to Week 36)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male or female at least 18 years of age
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
Subject has an active infection or a history of recent serious infections
Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
Subject had acute anterior uveitis within 6 weeks of Baseline
Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
Presence of active suicidal ideation, or moderately severe major depression or severe major depression
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Pa0011 50017
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Pa0011 50035
City
San Diego
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Pa0011 50004
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Pa0011 50033
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684-3176
Country
United States
Facility Name
Pa0011 50037
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Pa0011 50039
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pa0011 50024
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Pa0011 50028
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Pa0011 50023
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836
Country
United States
Facility Name
Pa0011 50015
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Pa0011 50026
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Pa0011 50047
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pa0011 50019
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Pa0011 50001
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pa0011 50016
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pa0011 50005
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Pa0011 50029
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pa0011 50010
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Pa0011 50011
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pa0011 50034
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Pa0011 50125
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pa0011 50031
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Pa0011 50040
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Pa0011 50020
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pa0011 50064
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pa0011 50006
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pa0011 50008
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Pa0011 50007
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Pa0011 50021
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
Pa0011 50012
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pa0011 50002
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Pa0011 50048
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Pa0011 50036
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Pa0011 50148
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Pa0011 50009
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Pa0011 50027
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Pa0011 50050
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Pa0011 30005
City
Camberwell
Country
Australia
Facility Name
Pa0011 30002
City
Clayton
Country
Australia
Facility Name
Pa0011 30001
City
Footscray
Country
Australia
Facility Name
Pa0011 30007
City
Victoria Park
Country
Australia
Facility Name
Pa0011 30006
City
Woodville
Country
Australia
Facility Name
Pa0011 50041
City
Quebec City
Country
Canada
Facility Name
Pa0011 50042
City
Rimouski
Country
Canada
Facility Name
Pa0011 50043
City
Sydney
Country
Canada
Facility Name
Pa0011 50045
City
Toronto
Country
Canada
Facility Name
Pa0011 50044
City
Trois-Rivières
Country
Canada
Facility Name
Pa0011 40009
City
Pardubice
Country
Czechia
Facility Name
Pa0011 40066
City
Praha 2
Country
Czechia
Facility Name
Pa0011 40063
City
Praha 5
Country
Czechia
Facility Name
Pa0011 40012
City
Zlín
Country
Czechia
Facility Name
Pa0011 40074
City
Bad Doberan
Country
Germany
Facility Name
Pa0011 40025
City
Berlin
Country
Germany
Facility Name
Pa0011 40028
City
Berlin
Country
Germany
Facility Name
Pa0011 40076
City
Cottbus
Country
Germany
Facility Name
Pa0011 40023
City
Erlangen
Country
Germany
Facility Name
Pa0011 40117
City
Frankfurt
Country
Germany
Facility Name
Pa0011 40029
City
Hamburg
Country
Germany
Facility Name
Pa0011 40071
City
Hamburg
Country
Germany
Facility Name
Pa0011 40027
City
Herne
Country
Germany
Facility Name
Pa0011 40078
City
Leipzig
Country
Germany
Facility Name
Pa0011 40348
City
Magdeburg
Country
Germany
Facility Name
Pa0011 40075
City
Püttlingen
Country
Germany
Facility Name
Pa0011 40026
City
Ratingen
Country
Germany
Facility Name
Pa0011 40083
City
Budapest
Country
Hungary
Facility Name
Pa0011 40030
City
Eger
Country
Hungary
Facility Name
Pa0011 40082
City
Kistarcsa
Country
Hungary
Facility Name
Pa0011 40079
City
Szentes
Country
Hungary
Facility Name
Pa0011 40084
City
Catania
Country
Italy
Facility Name
Pa0011 40087
City
Milano
Country
Italy
Facility Name
Pa0011 40085
City
Pisa
Country
Italy
Facility Name
Pa0011 40086
City
Reggio Emilia
Country
Italy
Facility Name
Pa0011 20039
City
Iruma
Country
Japan
Facility Name
Pa0011 20043
City
Itabashi-Ku
Country
Japan
Facility Name
Pa0011 20036
City
Kawachi-Nagano
Country
Japan
Facility Name
Pa0011 20045
City
Kita-Gun
Country
Japan
Facility Name
Pa0011 20049
City
Kitakyushu
Country
Japan
Facility Name
Pa0011 20044
City
Minato-Ku
Country
Japan
Facility Name
Pa0011 20033
City
Nagoya
Country
Japan
Facility Name
Pa0011 20038
City
Nankoku-shi
Country
Japan
Facility Name
Pa0011 20041
City
Osaka
Country
Japan
Facility Name
Pa0011 20046
City
Osaka
Country
Japan
Facility Name
Pa0011 20048
City
Saitama
Country
Japan
Facility Name
Pa0011 20031
City
Sapporo-City
Country
Japan
Facility Name
Pa0011 20042
City
Sasebo
Country
Japan
Facility Name
Pa0011 20032
City
Suita
Country
Japan
Facility Name
Pa0011 20030
City
Tokyo
Country
Japan
Facility Name
Pa0011 40119
City
Bydgoszcz
Country
Poland
Facility Name
Pa0011 40038
City
Elbląg
Country
Poland
Facility Name
Pa0011 40037
City
Lublin
Country
Poland
Facility Name
Pa0011 40091
City
Nowa Sól
Country
Poland
Facility Name
Pa0011 40044
City
Poznań
Country
Poland
Facility Name
Pa0011 40090
City
Poznań
Country
Poland
Facility Name
Pa0011 40118
City
Toruń
Country
Poland
Facility Name
Pa0011 40041
City
Warszawa
Country
Poland
Facility Name
Pa0011 40097
City
Warszawa
Country
Poland
Facility Name
Pa0011 40098
City
Warszawa
Country
Poland
Facility Name
Pa0011 40039
City
Wrocław
Country
Poland
Facility Name
Pa0011 40043
City
Wrocław
Country
Poland
Facility Name
Pa0011 20002
City
Moscow
Country
Russian Federation
Facility Name
Pa0011 20005
City
Moscow
Country
Russian Federation
Facility Name
Pa0011 20010
City
Moscow
Country
Russian Federation
Facility Name
Pa0011 20013
City
Petrozavodsk
Country
Russian Federation
Facility Name
Pa0011 20001
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0011 20004
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0011 20009
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0011 20007
City
Saratov
Country
Russian Federation
Facility Name
Pa0011 20014
City
Ulyanovsk
Country
Russian Federation
Facility Name
Pa0011 20006
City
Vladimir
Country
Russian Federation
Facility Name
Pa0011 20008
City
Yaroslavl
Country
Russian Federation
Facility Name
Pa0011 20015
City
Yaroslavl
Country
Russian Federation
Facility Name
Pa0011 40111
City
Bradford
Country
United Kingdom
Facility Name
Pa0011 40112
City
Cornwell
Country
United Kingdom
Facility Name
Pa0011 40109
City
Oxford
Country
United Kingdom
Facility Name
Pa0011 40108
City
Salford
Country
United Kingdom
Facility Name
Pa0011 40116
City
Stamford
Country
United Kingdom
Facility Name
Pa0011 40107
City
Wolverhampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
http://www.Vivli.org
Links:
URL
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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