Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults With Moderately to Severely Active Rheumatologic Disease
Spyre Therapeutics, Inc.
Summary
This is a multi-center, double-blind, placebo-controlled, Phase 2, proof-of-concept basket study with the goal of assessing the efficacy and safety of SPY072 compared to placebo in adults (aged ≥18 years) with rheumatic disease (RD).
Description
The basket study comprises of substudies in rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and psoriatric arthritis (PsA) as follows: * RA substudy: Moderately to severely active RA despite treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic disease modifying anti-rheumatic drugs (bDMARDs), or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs) * axSpA substudy: Moderately to severely active axSpA despite treatment with non-steroidal anti-inflammatory drugs (NSAIDS), bDMARDs, or tsDMARDs * PsA substudy: Moderately to s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: For rheumatoid arthritis: * Moderate-to-severely active RA as defined by the presence of ≥4 swollen joints (based on 28 joint count) and ≥4 tender joints (based on 28 joint count) at Screening and Day 1. * Documentation of ≥1 of the following: 1. Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR 2. Radiology report documenting bony erosions in hands or feet consistent with RA on previous radiographs * Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance)…
Interventions
- DrugSPY002-072
Experimental
- DrugPlacebo
Matching Placebo
Locations (64)
- Site 113Avondale, Arizona
- Site 118Tucson, Arizona
- Site 114Chula Vista, California
- Site 111Covina, California
- Site 108Tujunga, California
- Site 112Upland, California