Overview
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 severely active PsA despite treatment with NSAIDs, csDMARDs, bDMARDs, or tsDMARDs
Eligibility
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:
- Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR
- Previous radiographs with bony erosions in hands or feet consistent with RA
- Inadequate response (defined as signs and symptoms of persistently active disease,
loss of response, or intolerance) to one of the following:
- ≥1 csDMARD treatment; OR
- 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
For axial spondyloarthritis:
- Moderate-to-severely active axSpA defined by BOTH of the following at Screening AND
Day 1:
- BASDAI ≥4, AND
- Back pain ≥4 (from BASDAI Item 2)
- hsCRP greater than the ULN per the central laboratory at Screening - Inadequate
response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to one of the following:
- 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; OR
- 1 bDMARD (anti-TNF or anti-IL-17) or 1 tsDMARD treatment at an approved dose for ≥12 weeks (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
For psoriatic arthritis:
- Day 1 TJC ≥3 out of 68 and SJC ≥3 out of 66 (dactylitis counts as 1 joint each)
- ≥1 active plaque psoriasis lesion and/or a documented history of psoriasis
- In adequate response (defined as signs and symptoms of persistently active disease,
loss of response, or intolerance) to one of the following:
- ≥1 NSAID treatment; AND
- ≥1 csDMARD treatment; OR
- 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
Exclusion Criteria:
- Inadequate response to ≥2 or more bDMARDs and/or tsDMARDs
- Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072