A study to evaluate the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis
- Conditions
- Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-002804-29-GB
- Lead Sponsor
- CB Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 390
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>-Assess the safety and tolerability of bimekizumab<br>-Assess the impact of bimekizumab on patient-reported quality of life<br>-Assess the impact of bimekizumab on skin psoriasis (PSO) in the subgroup of affected subjects at Baseline<br>-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 Outcome Measures
Name Time Method