A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE VITAL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04009499 |
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Recruitment Status :
Active, not recruiting
First Posted : July 5, 2019
Last Update Posted : May 26, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriatic Arthritis | Drug: Bimekizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1131 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | August 13, 2019 |
| Estimated Primary Completion Date : | May 25, 2026 |
| Estimated Study Completion Date : | May 25, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bimekzumab dosage regimen
Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.
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Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
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- Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212) ]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 [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212) ]
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
- TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study [ Time Frame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212) ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]
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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 24 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 52 in PA0012 ]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 [ Time Frame: Baseline of PA0010 or PA0011, Week 140 in PA0012 ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009499
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| Study Director: | UCB Cares | 001 844 599 2273 |
| Responsible Party: | UCB Biopharma SRL |
| ClinicalTrials.gov Identifier: | NCT04009499 |
| Other Study ID Numbers: |
PA0012 2018-004725-86 ( EudraCT Number ) |
| First Posted: | July 5, 2019 Key Record Dates |
| Last Update Posted: | May 26, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| 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. |
| 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. |
| URL: | http://www.Vivli.org |
| 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 |
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Psoriatic Arthritis PsA Bimekizumab |
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Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis |
Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |