Status:
COMPLETED
A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
Lead Sponsor:
ACELYRIN Inc.
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 efficac...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2022
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04713072
Start Date
August 4 2020
End Date
January 27 2022
Last Update
February 9 2024
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie
Graz, Austria, 8036
2
Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II
Innsbruck, Austria, 6020
3
Vienna Medical University Department of Internal Medicine III Division of Rheumatology
Vienna, Austria, 1090
4
Katholieke Universiteit Leuven
Leuven, Belgium, 3000