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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

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
NA
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
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Belgium
State/province [23] 0 0
Genk
Country [24] 0 0
Belgium
State/province [24] 0 0
Leuven
Country [25] 0 0
Belgium
State/province [25] 0 0
Mons
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Rimouski
Country [28] 0 0
Canada
State/province [28] 0 0
Sydney
Country [29] 0 0
Canada
State/province [29] 0 0
Trois-rivieres
Country [30] 0 0
Czechia
State/province [30] 0 0
Brno
Country [31] 0 0
Czechia
State/province [31] 0 0
Ostrava
Country [32] 0 0
Czechia
State/province [32] 0 0
Pardubice
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 11
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha 2
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha 3
Country [36] 0 0
Czechia
State/province [36] 0 0
Praha 4
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha 5
Country [38] 0 0
Czechia
State/province [38] 0 0
Uherske Hradiste
Country [39] 0 0
Czechia
State/province [39] 0 0
Zlin
Country [40] 0 0
France
State/province [40] 0 0
Chambray Les Tours
Country [41] 0 0
France
State/province [41] 0 0
Paris
Country [42] 0 0
Germany
State/province [42] 0 0
Bad Doberan
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Cottbus
Country [45] 0 0
Germany
State/province [45] 0 0
Erlangen
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Herne
Country [49] 0 0
Germany
State/province [49] 0 0
Leipzig
Country [50] 0 0
Germany
State/province [50] 0 0
Ratingen
Country [51] 0 0
Hungary
State/province [51] 0 0
Budapest
Country [52] 0 0
Hungary
State/province [52] 0 0
Debrecen
Country [53] 0 0
Hungary
State/province [53] 0 0
Eger
Country [54] 0 0
Hungary
State/province [54] 0 0
Kistarcsa
Country [55] 0 0
Hungary
State/province [55] 0 0
Szentes
Country [56] 0 0
Hungary
State/province [56] 0 0
Székesfehérvár
Country [57] 0 0
Italy
State/province [57] 0 0
Catania
Country [58] 0 0
Italy
State/province [58] 0 0
Milano
Country [59] 0 0
Italy
State/province [59] 0 0
Reggio Emilia
Country [60] 0 0
Japan
State/province [60] 0 0
Bunkyo-ku
Country [61] 0 0
Japan
State/province [61] 0 0
Chuo-ku
Country [62] 0 0
Japan
State/province [62] 0 0
Itabashi-ku
Country [63] 0 0
Japan
State/province [63] 0 0
Kawachinagano
Country [64] 0 0
Japan
State/province [64] 0 0
Kita-gun
Country [65] 0 0
Japan
State/province [65] 0 0
Kitakyushu
Country [66] 0 0
Japan
State/province [66] 0 0
Minato-ku
Country [67] 0 0
Japan
State/province [67] 0 0
Nagoya
Country [68] 0 0
Japan
State/province [68] 0 0
Osaka
Country [69] 0 0
Japan
State/province [69] 0 0
Saitama
Country [70] 0 0
Japan
State/province [70] 0 0
Sapporo
Country [71] 0 0
Japan
State/province [71] 0 0
Sasebo
Country [72] 0 0
Japan
State/province [72] 0 0
Suita
Country [73] 0 0
Poland
State/province [73] 0 0
Bialystok
Country [74] 0 0
Poland
State/province [74] 0 0
Bydgoszcz
Country [75] 0 0
Poland
State/province [75] 0 0
Elblag
Country [76] 0 0
Poland
State/province [76] 0 0
Gdynia
Country [77] 0 0
Poland
State/province [77] 0 0
Krakow
Country [78] 0 0
Poland
State/province [78] 0 0
Lublin
Country [79] 0 0
Poland
State/province [79] 0 0
Nowa Sol
Country [80] 0 0
Poland
State/province [80] 0 0
Poznan
Country [81] 0 0
Poland
State/province [81] 0 0
Torun
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Poland
State/province [83] 0 0
Wroclaw
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Moscow
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Petrozavodsk
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Ryazan
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Saint Petersburg
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Saint-petersburg
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Saratov
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Ulyanovsk
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Vladimir
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Yaroslavl
Country [93] 0 0
Spain
State/province [93] 0 0
A Coruna
Country [94] 0 0
Spain
State/province [94] 0 0
Cordoba
Country [95] 0 0
Spain
State/province [95] 0 0
Málaga
Country [96] 0 0
Spain
State/province [96] 0 0
Sabadell
Country [97] 0 0
Spain
State/province [97] 0 0
Santiago de Compostela
Country [98] 0 0
Spain
State/province [98] 0 0
Sevilla
Country [99] 0 0
Spain
State/province [99] 0 0
Vigo
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Oxford
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Peterborough
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 prespecified 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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data from this study 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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.Vivli.org


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04009499