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SPY072 for rheumatoid, psoriatic, and axial spondyloarthritis

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

PHASE2 · Spyre Therapeutics, Inc. · NCT07148414

This trial will test whether SPY072 is safe and can reduce symptoms in adults with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who still have moderate-to-severe disease despite prior treatments.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment285 (estimated)
Ages18 Years and up
SexAll
SponsorSpyre Therapeutics, Inc. (industry)
Locations64 sites (Avondale, Arizona and 63 other locations)
Trial IDNCT07148414 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, multicenter, double-blind, placebo-controlled basket trial that tests SPY072 across separate substudies for rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Each substudy enrolls adults with moderate-to-severe disease despite standard therapies and applies disease-specific entry criteria (for example joint counts and serology/erosions for RA, BASDAI and hsCRP for axSpA). Participants are randomized to receive SPY072 or placebo and are followed for measures of efficacy and safety. The trial is designed as a proof-of-concept to see if SPY072 has activity across multiple rheumatic conditions.

Who should consider this trial

Good fit: Adults (age ≥18) with moderate-to-severe RA, PsA, or axSpA who remain symptomatic despite conventional and/or biologic or targeted therapies and who meet the study's specific lab and clinical entry criteria are the intended participants.

Not a fit: Patients with mild disease, those who do not meet the study's inclusion criteria (for example insufficient swollen/tender joint counts for RA or low hsCRP for axSpA), or RA patients who have failed more than two classes of bDMARDs/tsDMARDs are unlikely to be eligible or benefit from this trial.

Why it matters

Potential benefit: If successful, SPY072 could become a new treatment option that reduces inflammation and improves symptoms for patients with several rheumatic diseases who have not responded well to current therapies.

How similar studies have performed: Other therapies targeting inflammatory pathways have produced benefits in RA, PsA, and axSpA, but SPY072 appears to be a novel agent and this Phase 2 basket approach represents an early, proof-of-concept test.

Eligibility criteria

Show full inclusion / exclusion criteria 
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) to:

  1. ≥1 csDMARD treatment; AND/OR
  2. ≤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:

  1. BASDAI ≥4, AND
  2. 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:

  1. 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. ≤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. ≥1 NSAID treatment; AND
  2. ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (\>2 classes of bDMARDs and/or tsDMARDs is exclusionary)

Exclusion Criteria:

* 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 this trial is running

Avondale, Arizona and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Rheumatic Diseases, Rheumatic Joint Disease, PsA, AxSpA, Rheumatologic Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.