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Phase 3 Completed N=852 Randomized Triple-blind Treatment

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.
Annals of the rheumatic diseases · 2023 · Open access · High-confidence link

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)

  • 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.
    Annals of the rheumatic diseases · 2023 · 43 citations · Open access · High-confidence link
  • Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.
    Rheumatology and therapy · 2024 · 9 citations · Open access · High-confidence link
  • 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.
    Therapeutic advances in musculoskeletal disease · 2024 · 2 citations · Open access · High-confidence link
  • Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.
    Rheumatology and therapy · 2025 · 0 citations · Open access · High-confidence link
  • Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year.
    Dermatology and therapy · 2026 · 0 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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