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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: Bimekizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimekzumab dosage regimen<br>Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period. | Drug: Bimekizumab<br>* Subjects will receive bimekizumab at pre-specified time-points.<br>* Other names: UCB4940;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From PA0012 Entry Visit until Safety Follow-Up (up to Week 212) | 
| 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 | From PA0012 Entry Visit until Safety Follow-Up (up to Week 212) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From PA0012 Entry Visit until Safety Follow-Up (up to Week 212) | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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 | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 24 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 52 in PA0012 | 
| 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. | Baseline of PA0010 or PA0011, Week 140 in PA0012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, PsA, Bimekizumab