A Study of SPY072 in Rheumatic Disease
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Rheumatic Diseases, Rheumatic Joint Disease, PsA (Psoriatic Arthritis), AxSpA, Rheumatologic Disease
In brief
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).
Key facts
- Study ID
- NCT07148414
- Run by
- Spyre Therapeutics, Inc.
- People needed
- 285
- Starts
- 2025-08-21
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Inadequate response to >2 classes of bDMARDs/tsDMARDs
- Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072
Where it is running
- Site 118 — Tucson, Arizona, United States
- Site 114 — Chula Vista, California, United States
- Site 111 — Covina, California, United States
- Site 108 — Tujunga, California, United States
- Site 112 — Upland, California, United States
- Site 107 — Whittier, California, United States
- Site 115 — Aventura, Florida, United States
- Site 109 — Hialeah, Florida, United States
- Site 106 — Ormond Beach, Florida, United States
- Site 110 — Tampa, Florida, United States
- Site 116 — Willowbrook, Illinois, United States
- Site 119 — Rockville, Maryland, United States
- Site 104 — Duncansville, Pennsylvania, United States
- Site 105 — Corpus Christi, Texas, United States
- Site 120 — Irving, Texas, United States
- Site 103 — Tomball, Texas, United States
- Site 102 — Tomball, Texas, United States
- Site 503 — Lovech, Lovech, Bulgaria
- Site 502 — Pleven, Pleven, Bulgaria
- Site 506 — Plovdiv, Plovdiv, Bulgaria
- Site 505 — Plovdiv, Plovdiv, Bulgaria
- Site 504 — Varna, Varna, Bulgaria
- Site 706 — Hlučín, Hlučín, Czechia
- Site 702 — Moravská Ostrava, Ostrava-město, Czechia
- Site 113 — Avondale, Arizona, United States
Full record on ClinicalTrials.gov
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