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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506528-95-00
Acronym
PA0012
Enrollment
741
Registered
2024-07-11
Start date
2019-11-21
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Brief summary

1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of treatment-emergent serious adverse events (SAEs) during the study

Detailed description

TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study, American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the 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, American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the 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, American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the 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, American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the 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, American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011, Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011, Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011, Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011, Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011, Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011, Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the 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 24 from the 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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

Interventions

DRUGbimekizumab

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of treatment-emergent serious adverse events (SAEs) during the study

Secondary

MeasureTime frame
TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study, American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the 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, American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the 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, American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the 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, American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011, American College o

Countries

Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026