Psoriatic Arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subject is male or female at least 18 years of age -Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception -Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66 -Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies -Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO) -Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(a)) inhibitors for either PsA or PSO -Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: -Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study -Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO -Subject has an active infection or a history of recent serious infections -Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection -Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline -Subject had acute anterior uveitis within 6 weeks of Baseline -Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer -Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO) -Presence of active suicidal ideation, or moderately severe major depression or severe major depression -Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the clinical efficacy of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFa-IR) subjects with active Psoriatic Arthritis (PsA), as assessed by the American College of Rheumatology 50% improvement (ACR50) response;Secondary Objective: -Assess the efficacy of bimekizumab compared with placebo -Assess the safety and tolerability of bimekizumab -Assess the impact of bimekizumab on patient-reported quality of life -Assess the impact of bimekizumab on skin psoriasis (PSO) in the subgroup of affected subjects at Baseline -Assess the impact of bimekizumab on functional improvement;Primary end point(s): American College of Rheumatology (ACR) 50 response at Week 16 ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 2. Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline 3. Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in thesubgroup of subjects with psoriasis (PSO) involving at least 3% bodysurface area (BSA) at Baseline 4. Change from Baseline in the Short Form 36-item Health Survey (SF36) Physical Component Summary (PCS) score at Week 16 5. Minimal Disease Activity (MDA) at Week 16 6. American College of Rheumatology (ACR) 20 response at Week 16 7. American College of Rheumatology (ACR) 70 response at Week 16 8. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline 9. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline 10. Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16 11. Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16 12. Incidence of treatment-emergent adverse events (TEAEs) during the study 13. Incidence of treatment-emergent serious adverse events (SAEs) during the study 14. Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study ;Timepoint(s) of evaluation of this end point: 1, 3, 4, 9-11: Baseline, Week 16 2, 8: Baseline, Week 4 5-7: Week 16 12-14: From Baseline until Safety Follow-Up (up to Week 36) | — |
Countries
Australia, Canada, Czechia, Czech Republic, Germany, Hungary, Italy, Japan, Poland, Russian Federation, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed