A multicenter study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis which is a type of inflammatory arthritis.
- Conditions
- psoriatic arthritisMedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000018188Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-001103-23-DE
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- Subject has a documented diagnosis of adult-onset PsA classified by CASPAR criteria with symptoms for at least 6 months prior to Screening, with active PsA at Baseline/Day 1, and must have at Baseline TJC >=3 out of 78 and SJC >=3 out of 76
- Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- Subject must have a hs-CRP >=ULN
- Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
- Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline
- Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit
- Subjects taking MTX (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
- Subjects taking LEF (<=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16
- Subjects may be TNF inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
- -experienced an inadequate response to previous treatment given for at least 3 months
- -been intolerant to administration (eg, had a side-effect/AE that led to discontinuation)
- -lost access to TNF inhibitor for other reasons
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
- Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
- Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
- Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis
- Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
a) <= 3 excised or ablated basal cell carcinomas of the skin
b) One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
c) Actinic keratosis (-es)
d) Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 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: Assess the dose-response based on the efficacy of bimekizumab;Primary end point(s): ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12;Timepoint(s) of evaluation of this end point: Week 12;Secondary Objective: - Assess the efficacy of the individual dose regimens of bimekizumab compared to placebo<br>- Assess skin and nail psoriasis in the subgroup of affected subjects at baseline<br>- Assess the safety and tolerability of bimekizumab<br>- Assess the pharmacokinetics (PK) of bimekizumab<br>- Assess the pharmacodynamics (PD) of bimekizumab<br>- Assess the immunogenicity of bimekizumab<br>- Assess the exposure: response relationship of bimekizumab as it relates to efficacy and safety<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Baseline<br>Baseline/Day 1<br>Week 12;Secondary end point(s): - ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12<br>- ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12<br>- Psoriasis Area Severity Index (PASI90) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1<br>- Psoriasis Area Severity Index (PASI75) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1