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Completed

NCT Number: NCT04009499

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

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).

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pa0012 30005, Camberwell, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimekizumab

Drug

Subjects will receive bimekizumab at pre-specified time-points.

Other names: BKZ, UCB4940

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study 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

Acronym: BE VITAL

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2019
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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