Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults With Moderately to Severely Active Rheumatologic Disease
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).
∙ 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)