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A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE VITAL)

Primary Purpose

Psoriatic Arthritis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, PsA, Bimekizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Pa0012 50017
  • Pa0012 50035
  • Pa0012 50033
  • Pa0012 50037
  • Pa0012 50039
  • Pa0012 50024
  • Pa0012 50028
  • Pa0012 50023
  • Pa0012 50015
  • Pa0012 50026
  • Pa0012 50047
  • Pa0012 50019
  • Pa0012 50016
  • Pa0012 50005
  • Pa0012 50029
  • Pa0012 50010
  • Pa0012 50011
  • Pa0012 50034
  • Pa0012 50125
  • Pa0012 50031
  • Pa0012 50040
  • Pa0012 50020
  • Pa0012 50006
  • Pa0012 50008
  • Pa0012 50007
  • Pa0012 50001
  • Pa0012 50012
  • Pa0012 50002
  • Pa0012 50049
  • Pa0012 50036
  • Pa0012 50009
  • Pa0012 50050
  • Pa0012 30005
  • Pa0012 30002
  • Pa0012 30008
  • Pa0012 30003
  • Pa0012 30007
  • Pa0012 30006
  • Pa0012 40003
  • Pa0012 40002
  • Pa0012 40059
  • Pa0012 50041
  • Pa0012 50042
  • Pa0012 50043
  • Pa0012 50044
  • Pa0012 40061
  • Pa0012 40065
  • Pa0012 40062
  • Pa0012 40009
  • Pa0012 40013
  • Pa0012 40066
  • Pa0012 40015
  • Pa0012 40014
  • Pa0012 40063
  • Pa0012 40010
  • Pa0012 40012
  • Pa0012 40068
  • Pa0012 40019
  • Pa0012 40074
  • Pa0012 40025
  • Pa0012 40076
  • Pa0012 40023
  • Pa0012 40117
  • Pa0012 40029
  • Pa0012 40071
  • Pa0012 40027
  • Pa0012 40078
  • Pa0012 40026
  • Pa0012 40081
  • Pa0012 40083
  • Pa0012 40032
  • Pa0012 40030
  • Pa0012 40082
  • Pa0012 40079
  • Pa0012 40033
  • Pa0012 40084
  • Pa0012 40087
  • Pa0012 40086
  • Pa0012 20035
  • Pa0012 20030
  • Pa0012 20043
  • Pa0012 20036
  • Pa0012 20045
  • Pa0012 20049
  • Pa0012 20044
  • Pa0012 20033
  • Pa0012 20041
  • Pa0012 20046
  • Pa0012 20048
  • Pa0012 20031
  • Pa0012 20042
  • Pa0012 20032
  • Pa0012 40093
  • Pa0012 40119
  • Pa0012 40038
  • Pa0012 40088
  • Pa0012 40096
  • Pa0012 40042
  • Pa0012 40092
  • Pa0012 40037
  • Pa0012 40091
  • Pa0012 40044
  • Pa0012 40090
  • Pa0012 40118
  • Pa0012 40041
  • Pa0012 40094
  • Pa0012 40097
  • Pa0012 40098
  • Pa0012 40039
  • Pa0012 40043
  • Pa0012 40095
  • Pa0012 20002
  • Pa0012 20005
  • Pa0012 20010
  • Pa0012 20017
  • Pa0012 20013
  • Pa0012 20012
  • Pa0012 20016
  • Pa0012 20004
  • Pa0012 20001
  • Pa0012 20003
  • Pa0012 20009
  • Pa0012 20083
  • Pa0012 20007
  • Pa0012 20014
  • Pa0012 20006
  • Pa0012 20008
  • Pa0012 20015
  • Pa0012 40045
  • Pa0012 40105
  • Pa0012 40102
  • Pa0012 40101
  • Pa0012 40104
  • Pa0012 40049
  • Pa0012 40106
  • Pa0012 40099
  • Pa0012 40109
  • Pa0012 40116
  • Pa0012 40107

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bimekzumab dosage regimen

Arm Description

Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of treatment-emergent serious adverse events (SAEs) during the study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 2, 2019
Last Updated
September 14, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04009499
Brief Title
A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Acronym
BE VITAL
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
May 25, 2026 (Anticipated)
Study Completion Date
May 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, PsA, Bimekizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimekzumab dosage regimen
Arm Type
Experimental
Arm Description
Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
BKZ, UCB4940
Intervention Description
Subjects will receive bimekizumab at pre-specified time-points.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) during the study
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Title
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Description
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Secondary Outcome Measure Information:
Title
TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Title
American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Description
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0010 or PA0011.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
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
Description
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
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 24 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 52 in PA0012
Title
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
Description
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.
Time Frame
Baseline of PA0010 or PA0011, Week 140 in PA0012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
Pa0012 50017
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Pa0012 50035
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Pa0012 50033
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Pa0012 50037
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Pa0012 50039
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pa0012 50024
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Pa0012 50028
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Pa0012 50023
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836
Country
United States
Facility Name
Pa0012 50015
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Pa0012 50026
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Pa0012 50047
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-5817
Country
United States
Facility Name
Pa0012 50019
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48911
Country
United States
Facility Name
Pa0012 50016
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pa0012 50005
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Pa0012 50029
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pa0012 50010
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Pa0012 50011
City
New York
State/Province
New York
ZIP/Postal Code
10029-6501
Country
United States
Facility Name
Pa0012 50034
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Pa0012 50125
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Pa0012 50031
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Pa0012 50040
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377
Country
United States
Facility Name
Pa0012 50020
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pa0012 50006
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pa0012 50008
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Pa0012 50007
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Pa0012 50001
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Pa0012 50012
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5214
Country
United States
Facility Name
Pa0012 50002
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Pa0012 50049
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Pa0012 50036
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Pa0012 50009
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Pa0012 50050
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Pa0012 30005
City
Camberwell
Country
Australia
Facility Name
Pa0012 30002
City
Clayton
Country
Australia
Facility Name
Pa0012 30008
City
Hobart
Country
Australia
Facility Name
Pa0012 30003
City
Maroochydore
Country
Australia
Facility Name
Pa0012 30007
City
Victoria Park
Country
Australia
Facility Name
Pa0012 30006
City
Woodville South
Country
Australia
Facility Name
Pa0012 40003
City
Genk
Country
Belgium
Facility Name
Pa0012 40002
City
Leuven
Country
Belgium
Facility Name
Pa0012 40059
City
Mons
Country
Belgium
Facility Name
Pa0012 50041
City
Quebec City
Country
Canada
Facility Name
Pa0012 50042
City
Rimouski
Country
Canada
Facility Name
Pa0012 50043
City
Sydney
Country
Canada
Facility Name
Pa0012 50044
City
Trois-rivieres
Country
Canada
Facility Name
Pa0012 40061
City
Brno
Country
Czechia
Facility Name
Pa0012 40065
City
Brno
Country
Czechia
Facility Name
Pa0012 40062
City
Ostrava
Country
Czechia
Facility Name
Pa0012 40009
City
Pardubice
Country
Czechia
Facility Name
Pa0012 40013
City
Praha 11
Country
Czechia
Facility Name
Pa0012 40066
City
Praha 2
Country
Czechia
Facility Name
Pa0012 40015
City
Praha 3
Country
Czechia
Facility Name
Pa0012 40014
City
Praha 4
Country
Czechia
Facility Name
Pa0012 40063
City
Praha 5
Country
Czechia
Facility Name
Pa0012 40010
City
Uherske Hradiste
Country
Czechia
Facility Name
Pa0012 40012
City
Zlin
Country
Czechia
Facility Name
Pa0012 40068
City
Chambray Les Tours
Country
France
Facility Name
Pa0012 40019
City
Paris
Country
France
Facility Name
Pa0012 40074
City
Bad Doberan
Country
Germany
Facility Name
Pa0012 40025
City
Berlin
Country
Germany
Facility Name
Pa0012 40076
City
Cottbus
Country
Germany
Facility Name
Pa0012 40023
City
Erlangen
Country
Germany
Facility Name
Pa0012 40117
City
Frankfurt
Country
Germany
Facility Name
Pa0012 40029
City
Hamburg
Country
Germany
Facility Name
Pa0012 40071
City
Hamburg
Country
Germany
Facility Name
Pa0012 40027
City
Herne
Country
Germany
Facility Name
Pa0012 40078
City
Leipzig
Country
Germany
Facility Name
Pa0012 40026
City
Ratingen
Country
Germany
Facility Name
Pa0012 40081
City
Budapest
Country
Hungary
Facility Name
Pa0012 40083
City
Budapest
Country
Hungary
Facility Name
Pa0012 40032
City
Debrecen
Country
Hungary
Facility Name
Pa0012 40030
City
Eger
Country
Hungary
Facility Name
Pa0012 40082
City
Kistarcsa
Country
Hungary
Facility Name
Pa0012 40079
City
Szentes
Country
Hungary
Facility Name
Pa0012 40033
City
Székesfehérvár
Country
Hungary
Facility Name
Pa0012 40084
City
Catania
Country
Italy
Facility Name
Pa0012 40087
City
Milano
Country
Italy
Facility Name
Pa0012 40086
City
Reggio Emilia
Country
Italy
Facility Name
Pa0012 20035
City
Bunkyo-ku
Country
Japan
Facility Name
Pa0012 20030
City
Chuo-ku
Country
Japan
Facility Name
Pa0012 20043
City
Itabashi-ku
Country
Japan
Facility Name
Pa0012 20036
City
Kawachinagano
Country
Japan
Facility Name
Pa0012 20045
City
Kita-gun
Country
Japan
Facility Name
Pa0012 20049
City
Kitakyushu
Country
Japan
Facility Name
Pa0012 20044
City
Minato-ku
Country
Japan
Facility Name
Pa0012 20033
City
Nagoya
Country
Japan
Facility Name
Pa0012 20041
City
Osaka
Country
Japan
Facility Name
Pa0012 20046
City
Osaka
Country
Japan
Facility Name
Pa0012 20048
City
Saitama
Country
Japan
Facility Name
Pa0012 20031
City
Sapporo
Country
Japan
Facility Name
Pa0012 20042
City
Sasebo
Country
Japan
Facility Name
Pa0012 20032
City
Suita
Country
Japan
Facility Name
Pa0012 40093
City
Bialystok
Country
Poland
Facility Name
Pa0012 40119
City
Bydgoszcz
Country
Poland
Facility Name
Pa0012 40038
City
Elblag
Country
Poland
Facility Name
Pa0012 40088
City
Elblag
Country
Poland
Facility Name
Pa0012 40096
City
Gdynia
Country
Poland
Facility Name
Pa0012 40042
City
Krakow
Country
Poland
Facility Name
Pa0012 40092
City
Krakow
Country
Poland
Facility Name
Pa0012 40037
City
Lublin
Country
Poland
Facility Name
Pa0012 40091
City
Nowa Sol
Country
Poland
Facility Name
Pa0012 40044
City
Poznan
Country
Poland
Facility Name
Pa0012 40090
City
Poznan
Country
Poland
Facility Name
Pa0012 40118
City
Torun
Country
Poland
Facility Name
Pa0012 40041
City
Warszawa
Country
Poland
Facility Name
Pa0012 40094
City
Warszawa
Country
Poland
Facility Name
Pa0012 40097
City
Warszawa
Country
Poland
Facility Name
Pa0012 40098
City
Warszawa
Country
Poland
Facility Name
Pa0012 40039
City
Wroclaw
Country
Poland
Facility Name
Pa0012 40043
City
Wroclaw
Country
Poland
Facility Name
Pa0012 40095
City
Wroclaw
Country
Poland
Facility Name
Pa0012 20002
City
Moscow
Country
Russian Federation
Facility Name
Pa0012 20005
City
Moscow
Country
Russian Federation
Facility Name
Pa0012 20010
City
Moscow
Country
Russian Federation
Facility Name
Pa0012 20017
City
Moscow
Country
Russian Federation
Facility Name
Pa0012 20013
City
Petrozavodsk
Country
Russian Federation
Facility Name
Pa0012 20012
City
Ryazan
Country
Russian Federation
Facility Name
Pa0012 20016
City
Ryazan
Country
Russian Federation
Facility Name
Pa0012 20004
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0012 20001
City
Saint-petersburg
Country
Russian Federation
Facility Name
Pa0012 20003
City
Saint-petersburg
Country
Russian Federation
Facility Name
Pa0012 20009
City
Saint-petersburg
Country
Russian Federation
Facility Name
Pa0012 20083
City
Saint-petersburg
Country
Russian Federation
Facility Name
Pa0012 20007
City
Saratov
Country
Russian Federation
Facility Name
Pa0012 20014
City
Ulyanovsk
Country
Russian Federation
Facility Name
Pa0012 20006
City
Vladimir
Country
Russian Federation
Facility Name
Pa0012 20008
City
Yaroslavl
Country
Russian Federation
Facility Name
Pa0012 20015
City
Yaroslavl
Country
Russian Federation
Facility Name
Pa0012 40045
City
A Coruna
Country
Spain
Facility Name
Pa0012 40105
City
Cordoba
Country
Spain
Facility Name
Pa0012 40102
City
Málaga
Country
Spain
Facility Name
Pa0012 40101
City
Sabadell
Country
Spain
Facility Name
Pa0012 40104
City
Santiago de Compostela
Country
Spain
Facility Name
Pa0012 40049
City
Sevilla
Country
Spain
Facility Name
Pa0012 40106
City
Sevilla
Country
Spain
Facility Name
Pa0012 40099
City
Vigo
Country
Spain
Facility Name
Pa0012 40109
City
Oxford
Country
United Kingdom
Facility Name
Pa0012 40116
City
Peterborough
Country
United Kingdom
Facility Name
Pa0012 40107
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a 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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
http://www.Vivli.org

Learn more about this trial

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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