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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04009499
Ethics application status
Date submitted
2/07/2019
Date registered
5/07/2019
Date last updated
4/12/2020

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 - 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.
Timepoint [1] 0 0
From PA0012 Entry Visit until Safety Follow-Up (up to Week 160)
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From PA0012 Entry Visit until Safety Follow-Up (up to Week 160)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
From PA0012 Entry Visit until Safety Follow-Up (up to Week 160)
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 - The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to 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 - The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to 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 - The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to 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 - The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to 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 - The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to 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 - The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to 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 - The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to 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 - The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to 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 - The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to 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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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
Gender
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
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pa0012 30008 - Hobart
Recruitment hospital [2] 0 0
Pa0012 30006 - Maroochydore
Recruitment hospital [3] 0 0
Pa0012 30006 - Woodville South
Recruitment postcode(s) [1] 0 0
- Hobart
Recruitment postcode(s) [2] 0 0
- Maroochydore
Recruitment postcode(s) [3] 0 0
- Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
West Virginia
Country [21] 0 0
Canada
State/province [21] 0 0
Rimouski
Country [22] 0 0
Canada
State/province [22] 0 0
Sydney
Country [23] 0 0
Canada
State/province [23] 0 0
Trois-Rivières
Country [24] 0 0
Czechia
State/province [24] 0 0
Brno
Country [25] 0 0
Czechia
State/province [25] 0 0
Ostrava
Country [26] 0 0
Czechia
State/province [26] 0 0
Pardubice
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 2
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 3
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 4
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 5
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha
Country [32] 0 0
Czechia
State/province [32] 0 0
Uherské Hradi┼íte
Country [33] 0 0
Czechia
State/province [33] 0 0
Zlín
Country [34] 0 0
Germany
State/province [34] 0 0
Cottbus
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Kistarcsa
Country [38] 0 0
Hungary
State/province [38] 0 0
Szentes
Country [39] 0 0
Japan
State/province [39] 0 0
Chuo Ku
Country [40] 0 0
Japan
State/province [40] 0 0
Kawachi-Nagano-Shi
Country [41] 0 0
Japan
State/province [41] 0 0
Kita-Gun
Country [42] 0 0
Japan
State/province [42] 0 0
Osaka
Country [43] 0 0
Japan
State/province [43] 0 0
Sapporo
Country [44] 0 0
Japan
State/province [44] 0 0
Sasebo
Country [45] 0 0
Japan
State/province [45] 0 0
Suita
Country [46] 0 0
Poland
State/province [46] 0 0
Bialystok
Country [47] 0 0
Poland
State/province [47] 0 0
Bydgoszcz
Country [48] 0 0
Poland
State/province [48] 0 0
Elblag
Country [49] 0 0
Poland
State/province [49] 0 0
Gdynia
Country [50] 0 0
Poland
State/province [50] 0 0
Kraków
Country [51] 0 0
Poland
State/province [51] 0 0
Lublin
Country [52] 0 0
Poland
State/province [52] 0 0
Nowa Sól
Country [53] 0 0
Poland
State/province [53] 0 0
Poznan
Country [54] 0 0
Poland
State/province [54] 0 0
Torun
Country [55] 0 0
Poland
State/province [55] 0 0
Warsaw
Country [56] 0 0
Poland
State/province [56] 0 0
Warszawa
Country [57] 0 0
Poland
State/province [57] 0 0
Wroclaw
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Moscow
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Petrozavodsk
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Ryazan'
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Saint Petersburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saratov
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Ulyanovsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Vladimir
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Yaroslavl

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/show/NCT04009499
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273 (UCB)
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/show/NCT04009499