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Phase 3 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

Psoriatic Arthritis

Enrolled (actual)
852
Serious AEs
3.7%
Results posted
Oct 2024
Primary outcome: Primary: 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

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Bimekizumab (Drug); Adalimumab (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
UCB Biopharma SRL
Primary completion
Aug 2021

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

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).

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). 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.

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