A Study of SPY072 in Rheumatic Disease

Más betegség

• Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072

Egyéb

• Inadequate response to >2 classes of bDMARDs/tsDMARDs

• 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
  • 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) to:
  • ≥1 csDMARD treatment; AND/OR
  • ≤2 classes of bDMARD/tsDMARD treatment (>2 classes of 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:
  • 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; AND/OR
  • ≤2 classes of bDMARD (anti-TNF or anti-IL-17)/tsDMARD at an approved dose for ≥12 weeks (>2 classes of bDMARDs/tsDMARDs is exclusionary)
  • For psoriatic arthritis:
• Screening and 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
• Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
  • ≥1 NSAID treatment; AND
  • ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (>2 classes of bDMARDs and/or tsDMARDs is exclusionary)