Status:

RECRUITING

A Study of SPY072 in Rheumatic Disease

Lead Sponsor:

Spyre Therapeutics, Inc.

Conditions:

Rheumatoid Arthritis

Psoriatic Arthritis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 ye...

Detailed 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 despi...

Eligibility 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

Key Trial Info

Start Date :

August 21 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2028

Estimated Enrollment :

285 Patients enrolled

Trial Details

Trial ID

NCT07148414

Start Date

August 21 2025

End Date

March 31 2028

Last Update

February 4 2026

Active Locations (41)

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Page 1 of 11 (41 locations)

1

Site 113

Avondale, Arizona, United States, 85392

2

Site 114

Chula Vista, California, United States, 91910

3

Site 111

Covina, California, United States, 91722

4

Site 108

Tujunga, California, United States, 91042

A Study of SPY072 in Rheumatic Disease | DecenTrialz