NCT07148414

A Study of SPY072 in Rheumatic Disease

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Spyre Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Conditions

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Axial Spondyloarthritis
• Rheumatic Diseases
• Rheumatic Joint Disease
• PsA (Psoriatic Arthritis)
• AxSpA
• Rheumatologic Disease

Interventions

Type	Name	Description
DRUG	SPY002-072	Experimental
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2025-08-21
• Primary completion: 2026-10-31
• Completion: 2028-03-31
• First posted: 2025-08-29
• Last updated: 2026-02-04

Locations

41 sites across 7 countries: United States, Bulgaria, Czechia, Georgia, Moldova, Poland, Spain

Regulatory

• FDA-regulated drug study