Phase 3
Completed N=852
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT03895203 ↗Enrolled (actual)
852
Serious AEs
3.7%
Results posted
Oct 2024
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 — 10.0; 43.9; 45.7 percentage of participants — p=<0.001
◆ Published Evidence
Established
43citations · ~14 / year
Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study.
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 subjects with active Psoriatic Arthritis (PsA).
Linked Publications (5)
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Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study.
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Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.
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Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies.
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Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.
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Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 |
10.0; 43.9; 45.7 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ |
-0.0881; -0.2567 | <0.001 sig |
| SECONDARY Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline |
4.3; 19.8; 7.4 | — |
| SECONDARY Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline |
2.9; 61.3; 41.2 | <0.001 sig |
| SECONDARY Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ |
2.326; 6.219 | <0.001 sig |
| SECONDARY Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16 |
13.2; 45.0; 45.0 | <0.001 sig |
| SECONDARY Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ |
0.36; 0.04 | 0.001 sig |
| SECONDARY Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011 |
34.9; 49.8 | 0.008 sig |
| SECONDARY Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011 |
51.1; 75.6 | 0.002 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16 |
23.8; 62.2; 68.6 | — |
| SECONDARY Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in the Overall Population at Week 16 for Placebo and BKZ |
0.32; 0.04 | 0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology (ACR) 70 Response at Week 16 |
4.3; 24.4; 27.9 | — |
| SECONDARY Percentage of Participants With 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 |
3.9; 28.9; 11.3 | — |
| SECONDARY Percentage of Participants With an 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 |
3.9; 50.5; 33.9 | — |
| SECONDARY Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16 |
-6.3; -23.6; -25.7 | — |
| SECONDARY Percentage of Participants With an Enthesitis-free State Based on the Spondyloarthritis Research Consortium of Canada (SPARCC) Index at Week 16 in the Subgroup of Participants With Enthesitis at Baseline |
35.6; 50.0; 52.3 | — |
| SECONDARY Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16 |
-0.53; -1.83; -2.14 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study |
49.5; 59.6; 59.3; 70.5; 72.0; 68.4 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study |
1.1; 1.9; 1.4; 5.9; 5.6; 6.6 | — |
| SECONDARY Percentage of Participants With TEAEs Leading to Withdrawal From IMP During the Study |
1.1; 1.9; 2.1; 1.8; 2.7; 3.7 | — |
Eligibility Criteria
Inclusion Criteria
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
- Subject is male or female at least 18 years of age
- Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
- 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 for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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 (NCT03895203) and the linked publication. 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. Informational only — not medical advice.