RecruitingPhase 2

A Study of SPY072 in Rheumatic Disease

United States285 participantsStarted 2025-08-21

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. ≥1 csDMARD treatment; AND/OR

Exclusion criteria

✕. BASDAI ≥4, AND
✕. Back pain ≥4 (from BASDAI Item 2)
✕. 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)
✕. ≥1 NSAID treatment; AND
✕. ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (\>2 classes of bDMARDs and/or tsDMARDs is exclusionary)

What they're measuring

Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)

Timeframe: Week 12

Axial Spondyloarthritis: Change from baseline in Ankylosing Spondylitis Disease Activity Score (ADAS)

Timeframe: Week 16

Psoriatic Arthritis: Proportion of participants who achieve an American College of Rheumatology 20 Response Criteria (ACR20) response

Timeframe: Week 16

Trial details

NCT IDNCT07148414

SponsorSpyre Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

SKYWAY-RD Trial Center

+1-650-402-3164 info@skyway-rd.com

View on ClinicalTrials.gov More Rheumatoid Arthritis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. ≥1 csDMARD treatment; AND/OR

Exclusion criteria

✕. BASDAI ≥4, AND
✕. Back pain ≥4 (from BASDAI Item 2)
✕. 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)
✕. ≥1 NSAID treatment; AND
✕. ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (\>2 classes of bDMARDs and/or tsDMARDs is exclusionary)

What they're measuring

Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)

Timeframe: Week 12

Axial Spondyloarthritis: Change from baseline in Ankylosing Spondylitis Disease Activity Score (ADAS)

Timeframe: Week 16

Psoriatic Arthritis: Proportion of participants who achieve an American College of Rheumatology 20 Response Criteria (ACR20) response

Timeframe: Week 16