Psoriatic Arthritis
Conditions
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).
Interventions
BIOLOGICALABY-035
ABY-035 solution for injection
BIOLOGICALPlacebo
Placebo to ABY-035 solution for injection
Sponsors
ACELYRIN Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient who has given his / her signed declaration of consent and data protection declaration * At least 18 years and less than 75 years of age at Screening visit * Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history. * Active psoriatic arthritis defined by: * ≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit * ≥3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit * Precedent failure or insufficient treatment response to or contraindication or intolerability to nonsteroidal anti-inflammatory drug (NSAID), csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A), and/or TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab) * Rheumatoid factor (RF) and anti-CCP antibody negative * Presence or history of plaque psoriasis
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 50 response rate (ACR50) | 16 weeks | ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo |
| ACR50 | 12 weeks | ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR20/70 | 16 weeks | ACR20/70 response rate, percentage of patients achieving Minimal Disease Activity (MDA): at V9 (Week 16) for higher Dose vs. Placebo |
| ACR20/50/70 | 16 weeks | ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo |
| ACR 20/50/70 | 8 weeks | ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo |
Countries
Austria, Belgium, Czechia, Germany, Hungary, Poland, Spain
Outcome results
None listed