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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04009499




Registration number
NCT04009499
Ethics application status
Date submitted
2/07/2019
Date registered
5/07/2019
Date last updated
15/10/2024

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
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
Secondary ID [1] 0 0
2018-004725-86
Secondary ID [2] 0 0
PA0012
Universal Trial Number (UTN)
Trial acronym
BE VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs) during the study
Timepoint [1] 0 0
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Primary outcome [2] 0 0
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Timepoint [2] 0 0
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Secondary outcome [1] 0 0
TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study
Timepoint [1] 0 0
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Secondary outcome [2] 0 0
American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [2] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary outcome [3] 0 0
American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [3] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary outcome [4] 0 0
American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [4] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary outcome [5] 0 0
American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [5] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary outcome [6] 0 0
American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [6] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary outcome [7] 0 0
American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [7] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary outcome [8] 0 0
American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [8] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary outcome [9] 0 0
American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [9] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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
Timepoint [10] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary outcome [11] 0 0
Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [11] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary outcome [12] 0 0
Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [12] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary outcome [13] 0 0
Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [13] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
Secondary outcome [14] 0 0
Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [14] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
Secondary outcome [15] 0 0
Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [15] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
Secondary outcome [16] 0 0
Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Timepoint [16] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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
Timepoint [17] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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
Timepoint [18] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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
Timepoint [19] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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
Timepoint [20] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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
Timepoint [21] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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
Timepoint [22] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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
Timepoint [23] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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
Timepoint [24] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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
Timepoint [25] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012
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
Timepoint [26] 0 0
Baseline of PA0010 or PA0011, Week 24 in PA0012
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
Timepoint [27] 0 0
Baseline of PA0010 or PA0011, Week 52 in PA0012
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
Timepoint [28] 0 0
Baseline of PA0010 or PA0011, Week 140 in PA0012

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/05/2026
Actual
Sample size
Target
Accrual to date
Final
1131
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pa0012 30005 - Camberwell
Recruitment hospital [2] 0 0
Pa0012 30002 - Clayton
Recruitment hospital [3] 0 0
Pa0012 30008 - Hobart
Recruitment hospital [4] 0 0
Pa0012 30003 - Maroochydore
Recruitment hospital [5] 0 0
Pa0012 30007 - Victoria Park
Recruitment hospital [6] 0 0
Pa0012 30006 - Woodville South
Recruitment postcode(s) [1] 0 0
- Camberwell
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Maroochydore
Recruitment postcode(s) [5] 0 0
- Victoria Park
Recruitment postcode(s) [6] 0 0
- Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
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New Jersey
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New Mexico
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United States of America
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New York
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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West Virginia
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Belgium
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Genk
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Belgium
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Leuven
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Belgium
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Mons
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Canada
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Quebec
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Canada
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Rimouski
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Sydney
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Canada
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Trois-rivieres
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Czechia
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Brno
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Czechia
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Ostrava
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Czechia
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Pardubice
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Praha 11
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Uherske Hradiste
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Czechia
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Zlin
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France
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Chambray Les Tours
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Frankfurt
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Hamburg
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Herne
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Leipzig
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Ratingen
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Budapest
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Hungary
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Debrecen
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Eger
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Kistarcsa
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Szentes
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Székesfehérvár
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Catania
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Chuo-ku
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Itabashi-ku
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Kawachinagano
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Kita-gun
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Kitakyushu
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Minato-ku
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Nagoya
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Osaka
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Saitama
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Sapporo
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Sasebo
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Japan
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Suita
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Gdynia
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Poland
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Krakow
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Poland
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Lublin
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Nowa Sol
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Poznan
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Torun
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Warszawa
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Wroclaw
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Russian Federation
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Moscow
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Russian Federation
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Petrozavodsk
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-petersburg
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Russian Federation
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Saratov
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Russian Federation
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Ulyanovsk
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Russian Federation
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Vladimir
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Russian Federation
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Yaroslavl
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Spain
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A Coruna
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Spain
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Cordoba
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Spain
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Málaga
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Spain
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Sabadell
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
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Vigo
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United Kingdom
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Oxford
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United Kingdom
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Peterborough
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT04009499
Trial related presentations / publications
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.
Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 Sep 1;63(9):2399-2410. doi: 10.1093/rheumatology/keae277.
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04009499