A Study of SPY072 in Rheumatic Disease

Last updated: January 5, 2026
Sponsor: Spyre Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Rheumatoid Arthritis

Lupus

Ankylosing Spondylitis

Treatment

SPY002-072

Placebo

Clinical Study ID

NCT07148414
SPY002-072-201
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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) atScreening and Day 1.

  • Documentation of ≥1 of the following:

  1. Positive test results for rheumatoid factor or anti-citrullinated peptideantibodies 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 isexclusionary)

For axial spondyloarthritis:

  • Moderate-to-severely active axSpA defined by BOTH of the following at Screening ANDDay 1:
  1. BASDAI ≥4, AND

  2. Back pain ≥4 (from BASDAI Item 2)

  • hsCRP greater than the ULN per the central laboratory at Screening - Inadequateresponse (defined as signs and symptoms of persistently active disease, loss ofresponse, or intolerance) to one of the following:
  1. 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks orintolerant 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 dosefor ≥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 isexclusionary)

Exclusion

Exclusion Criteria:

  • Inadequate response to ≥2 or more bDMARDs and/or tsDMARDs

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

Study Design

Total Participants: 285
Treatment Group(s): 2
Primary Treatment: SPY002-072
Phase: 2
Study Start date:
August 21, 2025
Estimated Completion Date:
March 31, 2028

Study 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

Connect with a study center

  • Site 503

    Lovech 729559, Lovech 729560 5500
    Bulgaria

    Active - Recruiting

  • Site 704

    Pardubice 3068582, Pardubický kraj 3339574 530 02
    Czechia

    Active - Recruiting

  • Site 301

    Tbilisi 611717, K'alak'i T'bilisi 611716 0159
    Georgia

    Active - Recruiting

  • Site 303

    Tbilisi 611717, K'alak'i T'bilisi 611716 0102
    Georgia

    Active - Recruiting

  • Site 304

    Tbilisi 611717, K'alak'i T'bilisi 611716 0112
    Georgia

    Active - Recruiting

  • Site 305

    Tbilisi 611717, K'alak'i T'bilisi 611716 0186
    Georgia

    Active - Recruiting

  • Site 307

    Tbilisi 611717, K'alak'i T'bilisi 611716 0172
    Georgia

    Active - Recruiting

  • Site 308

    Batumi 615532, 6010
    Georgia

    Active - Recruiting

  • Site 302

    Kutaisi 613607, 4600
    Georgia

    Active - Recruiting

  • Site 306

    Tbilisi 611717, 0186
    Georgia

    Active - Recruiting

  • Site 201

    Chisinau 618426, MD-2025
    Moldova

    Active - Recruiting

  • Site 202

    Chisinau 618426, MD-2025
    Moldova

    Active - Recruiting

  • Site 401

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-363
    Poland

    Active - Recruiting

  • Site 403

    Warsaw 756135, Masovian Voivodeship 858787 02-677
    Poland

    Active - Recruiting

  • Site 405

    Warszawa, Pomeranian Voivodeship 3337496 00-874
    Poland

    Active - Recruiting

  • Site 113

    Avondale 5552301, Arizona 5551752 85392
    United States

    Active - Recruiting

  • Site 114

    Chula Vista 5336899, California 5332921 91910
    United States

    Active - Recruiting

  • Site 111

    Covina 5340175, California 5332921 91722
    United States

    Active - Recruiting

  • Site 108

    Tujunga 5403767, California 5332921 91042
    United States

    Active - Recruiting

  • Site 112

    Upland 5404915, California 5332921 91786
    United States

    Active - Recruiting

  • Site 107

    Whittier 5409059, California 5332921 90602
    United States

    Active - Recruiting

  • Site 109

    Hialeah 4158476, Florida 4155751 33016
    United States

    Active - Recruiting

  • Site 106

    Ormond Beach 4167178, Florida 4155751 32174
    United States

    Active - Recruiting

  • Site 110

    Tampa 4174757, Florida 4155751 33614
    United States

    Active - Recruiting

  • Site 101

    Brookline 4931482, Massachusetts 6254926 02446
    United States

    Active - Recruiting

  • Site 104

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Active - Recruiting

  • Site 105

    Corpus Christi 4683416, Texas 4736286 78404
    United States

    Active - Recruiting

  • Site 102

    Tomball 4737094, Texas 4736286 77377
    United States

    Active - Recruiting

  • Site 103

    Tomball 4737094, Texas 4736286 77375
    United States

    Active - Recruiting

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