Phase 3
N=400
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03896581 ↗Enrolled (actual)
400
Serious AEs
1.3%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Participants With American College of Rheumatology 50 (ACR50) Response — 6.8; 43.4 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bimekizumab (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With American College of Rheumatology 50 (ACR50) Response |
6.8; 43.4 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16 |
-0.0701; -0.3751 | <0.001 sig |
| SECONDARY Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline |
0; 26.7 | — |
| SECONDARY Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline |
6.8; 68.8 | <0.001 sig |
| SECONDARY Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 |
1.413; 7.258 | <0.001 sig |
| SECONDARY Minimal Disease Activity (MDA) at Week 16 |
6.0; 44.2 | <0.001 sig |
| SECONDARY Percentage of Participants With American College of Rheumatology 20 (ACR20) Response |
15.8; 67.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70 (ACR70) Response |
0.8; 26.6 | — |
| SECONDARY 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 Participants With Psoriatic Skin Lesions at Baseline |
1.2; 30.7 | — |
| SECONDARY 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 Participants With Psoriatic Skin Lesions at Baseline |
3.7; 60.7 | — |
| SECONDARY Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16 |
-4.5; -27.7 | — |
| SECONDARY Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16 |
-0.32; -2.24 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study |
44; 108 | — |
| SECONDARY Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study |
0; 5 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study |
0; 2 | — |
Summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).
Eligibility 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(α)) 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
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
Data sourced from ClinicalTrials.gov (NCT03896581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.