psoriatic arthritic MedDRA version: 19.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
UCB Biopharma SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the dose-response based on the efficacy of bimekizumab;Secondary Objective: - Assess the efficacy of the individual dose regimens of bimekizumab compared to placebo - Assess skin and nail psoriasis in the subgroup of affected subjects at baseline - Assess the safety and tolerability of bimekizumab - Assess the pharmacokinetics (PK) of bimekizumab - Assess the pharmacodynamics (PD) of bimekizumab - Assess the immunogenicity of bimekizumab - Assess the exposure: response relationship of bimekizumab as it relates to efficacy and safety ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 - ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 - 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 - 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;Timepoint(s) of evaluation of this end point: Baseline Baseline/Day 1 Week 12 | — |
Countries
Czech Republic, Germany, Hungary, Poland, Russian Federation, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed