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NCT07148414 | RECRUITING | Rheumatoid Arthritis

A Study of SPY072 in Rheumatic Disease
Sponsor:

Spyre Therapeutics, Inc.

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 years) with rheumatic disease (RD).

Condition or disease

Rheumatoid Arthritis

Psoriatic Arthritis

Axial Spondyloarthritis

Rheumatic Diseases

Rheumatic Joint Disease

PsA (Psoriatic Arthritis)

Axpa

Rheumatologic Disease

Intervention/treatment

SPY002-072

Placebo

Phase

PHASE2

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 despite treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic disease modifying anti-rheumatic drugs (bDMARDs), or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs) * axSpA substudy: Moderately to severely active axSpA despite treatment with non-steroidal anti-inflammatory drugs (NSAIDS), bDMARDs, or tsDMARDs * PsA substudy: Moderately to severely active PsA despite treatment with NSAIDs, csDMARDs, bDMARDs, or tsDMARDs

Study Type : INTERVENTIONAL
Estimated Enrollment : 285 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults With Moderately to Severely Active Rheumatologic Disease
Actual Study Start Date : 2025-08-21
Estimated Primary Completion Date : 2026-10-31
Estimated Study Completion Date : 2028-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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. 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. ≥1 csDMARD treatment; OR
        • 2. 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
            • 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 one of the following
              • 1. 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; OR
              • 2. 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. ≥1 NSAID treatment; AND
                  • 2. ≥1 csDMARD treatment; OR
                  • 3. 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
                  Exclusion Criteria
                  • * Inadequate response to ≥2 or more bDMARDs and/or tsDMARDs
                  • * Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072
A Study of SPY072 in Rheumatic Disease

Location Details

NCT07148414

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Site 114

Chula Vista, California, United States, 91910

RECRUITING

United States, California

Site 111

Covina, California, United States, 91722

RECRUITING

United States, California

Site 108

Destination, California, United States, 91042

RECRUITING

United States, California

Site 112

Upland, California, United States, 91786

RECRUITING

United States, California

Site 107

Whittier, California, United States, 90602

RECRUITING

United States, Massachusetts

Site 101

Brookline, Massachusetts, United States, 02446

RECRUITING

United States, Pennsylvania

Site 104

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Texas

Site 105

Corpus Christi, Texas, United States, 78404

RECRUITING

United States, Texas

Site 103

Tomball, Texas, United States, 77375

RECRUITING

United States, Texas

Site 102

Tomball, Texas, United States, 77377