A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Clinical Trial in Patients With Active Psoriatic Arthritis to Investigate Efficacy, Tolerability, Safety, Pharmacokinetics and Immunogenicity of ABY-035
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Psoriatic Arthritis
- Sponsor
- ACELYRIN Inc.
- Enrollment
- 129
- Locations
- 32
- Primary Endpoint
- American College of Rheumatology 50 response rate (ACR50)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA.
Detailed Description
The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit) comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of follow-up. Treatment Periods are: * Treatment Period I: from V1 (Week 0) to V9 (Week 16) * Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing) At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal rates (1:1:1) to one of three parallel groups (A, B, C). The treatment will be administered once every 2 weeks (Q2W). Patients assigned to groups A and B will receive active treatment from V1 to V16 (group A = 40 mg ABY-035; group B = 80 mg ABY-035). Patients initially assigned to placebo will switch to active treatment at visit V9 in a blinded fashion (group C = Placebo from V1 to V8 and 80 mg ABY-035 from V9 to V16).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Underlying conditions which significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
- •History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
- •History of or current fibromyalgia or pain syndrome
- •Uncontrolled inflammatory bowel disease
- •Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit
- •Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
- •History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
- •Insufficiently controlled heart failure
- •Current uncontrolled arterial hyper- or hypotension
Outcomes
Primary Outcomes
American College of Rheumatology 50 response rate (ACR50)
Time Frame: 16 weeks
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
ACR50
Time Frame: 12 weeks
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
Secondary Outcomes
- ACR20/70(12 weeks)
- ACR20/50/70(12 weeks)
- ACR 20/50/70(8 weeks)