Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07148414

PHASE2

A Study of SPY072 in Rheumatic Disease

Sponsor: Spyre Therapeutics, Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

285

Start Date

2025-08-21

Completion Date

2028-03-31

Last Updated

2026-05-08

Healthy Volunteers

Conditions

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

Interventions

DRUG

SPY002-072

Experimental

DRUG

Placebo

Matching Placebo

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

Locations (64)

Site 113

Avondale, Arizona, United States

Site 118

Tucson, Arizona, United States

Site 114

Chula Vista, California, United States

Site 111

Covina, California, United States

Site 108

Tujunga, California, United States

Site 112

Upland, California, United States

Site 107

Whittier, California, United States

Site 115

Aventura, Florida, United States

Site 109

Hialeah, Florida, United States

Site 106

Ormond Beach, Florida, United States

Site 110

Tampa, Florida, United States

Site 116

Willowbrook, Illinois, United States

Site 119

Rockville, Maryland, United States

Site 104

Duncansville, Pennsylvania, United States

Site 105

Corpus Christi, Texas, United States

Site 120

Irving, Texas, United States

Site 103

Tomball, Texas, United States

Site 102

Tomball, Texas, United States

Site 503

Lovech, Lovech, Bulgaria

Site 502

Pleven, Pleven, Bulgaria

Site 506

Plovdiv, Plovdiv, Bulgaria

Site 505

Plovdiv, Plovdiv, Bulgaria

Site 504

Varna, Varna, Bulgaria

Site 706

Hlučín, Hlučín, Czechia

Site 702

Moravská Ostrava, Ostrava-město, Czechia

Site 704

Pardubice, Pardubice Region, Czechia

Site 705

Prague, Praha, Hlavní Mesto, Czechia

Site 703

Prague, Praha, Hlavní Mesto, Czechia

Site 701

Uherské Hradiště, Zlín, Czechia

Site 303