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Clinical Trials in the USA / NCT07148414
Active, not recruiting Phase 2

A Study of SPY072 in Rheumatic Disease

NCT07148414 · tracked via the Priya Life Science USA tracker
Sponsor
Spyre Therapeutics, Inc.
Phase
Phase 2
Started
2025-08-21
Last updated
2026-06-05

Condition(s) studied

Rheumatoid ArthritisPsoriatic ArthritisAxial SpondyloarthritisRheumatic DiseasesRheumatic Joint DiseasePsA (Psoriatic Arthritis)AxSpARheumatologic Disease

Investigational drug(s) / intervention(s)

SPY002-072Placebo

SPY002-072: Experimental

Placebo: Matching Placebo

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
Site 113 Avondale Arizona
Site 118 Tucson Arizona
Site 114 Chula Vista California
Site 111 Covina California
Site 108 Tujunga California
Site 112 Upland California
Site 107 Whittier California
Site 115 Aventura Florida
Site 109 Hialeah Florida
Site 106 Ormond Beach Florida
Site 110 Tampa Florida
Site 116 Willowbrook Illinois
Site 119 Rockville Maryland
Site 104 Duncansville Pennsylvania
Site 105 Corpus Christi Texas
Site 120 Irving Texas
Site 103 Tomball Texas
Site 102 Tomball Texas
Site 503 Lovech Lovech
Site 502 Pleven Pleven
Site 506 Plovdiv Plovdiv
Site 505 Plovdiv Plovdiv
Site 504 Varna Varna
Site 706 Hlučín Hlučín
Site 702 Moravská Ostrava Ostrava-město
Site 704 Pardubice Pardubice Region
Site 705 Prague Praha, Hlavní Mesto
Site 703 Prague Praha, Hlavní Mesto
Site 701 Uherské Hradiště Zlín
Site 303 Tbilisi K'alak'i T'bilisi
Site 304 Tbilisi K'alak'i T'bilisi
Site 301 Tbilisi K'alak'i T'bilisi
Site 307 Tbilisi K'alak'i T'bilisi
Site 305 Tbilisi K'alak'i T'bilisi
Site 308 Batumi Georgia
Site 302 Kutaisi Georgia
Site 306 Tbilisi Georgia
Site 201 Chisinau Moldova
Site 202 Chisinau Moldova
Site 401 Krakow Lesser Poland Voivodeship

+ 24 more sites — see the full list on the official registry below.

More Spyre Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07148414 on ClinicalTrials.gov ↗ ← All trials in the USA