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Trial Review
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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04009499
Registration number
NCT04009499
Ethics application status
Date submitted
2/07/2019
Date registered
5/07/2019
Date last updated
24/05/2024
Titles & IDs
Public title
A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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Scientific title
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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Secondary ID [1]
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0
2018-004725-86
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Secondary ID [2]
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0
PA0012
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Universal Trial Number (UTN)
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Trial acronym
BE VITAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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0
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0
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Osteoarthritis
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Inflammatory and Immune System
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0
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0
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Rheumatoid arthritis
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Inflammatory and Immune System
0
0
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
0
0
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Experimental: Bimekzumab dosage regimen - Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.
Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs) during the study
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Assessment method [1]
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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.
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Timepoint [1]
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From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
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Primary outcome [2]
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Incidence of treatment-emergent serious adverse events (SAEs) during the study
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Assessment method [2]
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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
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Timepoint [2]
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From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
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Secondary outcome [1]
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TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study
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Assessment method [1]
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0
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.
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Timepoint [1]
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0
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
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Secondary outcome [2]
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American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [2]
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The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [2]
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Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [3]
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American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [3]
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The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [3]
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Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [4]
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American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [4]
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The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [4]
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Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [5]
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American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [5]
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The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [5]
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Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [6]
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American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [6]
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0
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [6]
0
0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [7]
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American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [7]
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0
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [7]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [8]
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American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [8]
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The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [8]
0
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Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [9]
0
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American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [9]
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0
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [9]
0
0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [10]
0
0
American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [10]
0
0
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
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Timepoint [10]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [11]
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Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [11]
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The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.
The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
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Timepoint [11]
0
0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [12]
0
0
Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [12]
0
0
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.
The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
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Timepoint [12]
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0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [13]
0
0
Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [13]
0
0
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.
The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
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Timepoint [13]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [14]
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Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [14]
0
0
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.
The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
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Timepoint [14]
0
0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [15]
0
0
Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [15]
0
0
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.
The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Query!
Timepoint [15]
0
0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [16]
0
0
Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
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Assessment method [16]
0
0
The PASI will be assessed for the purposes of determining response only in subjects with psoriasis (PSO) involving at =3% of body surface area (BSA) at Baseline of PA0010 or PA0011.
The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline of of PA0010 or PA0011.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Query!
Timepoint [16]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [17]
0
0
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011
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Assessment method [17]
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0
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA =2 at the Baseline of PA0010 or PA0011.
An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
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Timepoint [17]
0
0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [18]
0
0
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011
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Assessment method [18]
0
0
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA =2 at the Baseline of PA0010 or PA0011.
An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011.
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Timepoint [18]
0
0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [19]
0
0
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011
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Assessment method [19]
0
0
A static Investigator Global Assessment (IGA) for psoriasis (PSO) will be used to assess disease severity during the study only for subjects with IGA =2 at the Baseline of PA0010 or PA0011.
An IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline of PA0010 or PA0011
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Timepoint [19]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [20]
0
0
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
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Assessment method [20]
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0
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
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Timepoint [20]
0
0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [21]
0
0
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
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Assessment method [21]
0
0
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
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Timepoint [21]
0
0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [22]
0
0
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
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Assessment method [22]
0
0
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline of PA0010 or PA0011.
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Timepoint [22]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [23]
0
0
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
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Assessment method [23]
0
0
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
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Timepoint [23]
0
0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [24]
0
0
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
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Assessment method [24]
0
0
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
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Timepoint [24]
0
0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [25]
0
0
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
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Assessment method [25]
0
0
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline of PA0010 or PA0011. The Spondyloarthritis Research Consortium of Canada (SPARCC) is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
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Timepoint [25]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Secondary outcome [26]
0
0
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
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Assessment method [26]
0
0
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
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Timepoint [26]
0
0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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Secondary outcome [27]
0
0
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
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Assessment method [27]
0
0
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
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Timepoint [27]
0
0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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Secondary outcome [28]
0
0
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
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Assessment method [28]
0
0
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline of PA0010 or PA0011.
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Timepoint [28]
0
0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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Eligibility
Key inclusion criteria
- In the opinion of the Investigator, the subject is expected to benefit from
participation in this Open-Label Extension study
- Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any
withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or willing to use a
highly effective method of contraception
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Female subjects who plan to become pregnant during the study or within 20 weeks
following the last dose of investigational medicinal product (IMP)
- Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an
ongoing serious adverse event (SAE), or a history of serious infections (including
hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior
to the subject's entry into PA0012, although the decision to enroll the subject
remains with the Investigator
- Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in
one of the feeder studies, unless appropriately evaluated and treated
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/05/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
1131
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Pa0012 30005 - Camberwell
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Recruitment hospital [2]
0
0
Pa0012 30002 - Clayton
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Recruitment hospital [3]
0
0
Pa0012 30008 - Hobart
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Recruitment hospital [4]
0
0
Pa0012 30003 - Maroochydore
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Recruitment hospital [5]
0
0
Pa0012 30007 - Victoria Park
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Recruitment hospital [6]
0
0
Pa0012 30006 - Woodville South
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Recruitment postcode(s) [1]
0
0
- Camberwell
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Recruitment postcode(s) [2]
0
0
- Clayton
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Recruitment postcode(s) [3]
0
0
- Hobart
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Recruitment postcode(s) [4]
0
0
- Maroochydore
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Recruitment postcode(s) [5]
0
0
- Victoria Park
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Recruitment postcode(s) [6]
0
0
- Woodville South
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Idaho
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kentucky
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Louisiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New Jersey
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Mexico
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New York
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Country [15]
0
0
United States of America
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State/province [15]
0
0
North Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Ohio
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Pennsylvania
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Rhode Island
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Country [19]
0
0
United States of America
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State/province [19]
0
0
South Carolina
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Country [20]
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Czechia
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Czechia
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Czechia
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Czechia
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Uherske Hradiste
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Zlin
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France
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Wolverhampton
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Funding & Sponsors
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Name
UCB Biopharma SRL
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Summary
Brief summary
This is a study to assess the long-term safety, long-term efficacy and tolerability of
bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis
(PsA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04009499
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Principal investigator
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UCB Cares
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001 844 599 2273
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04009499
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