RECRUITING

A Study of SPY072 in Rheumatic Disease

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-08-21
Study Completion:2028-03-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07148414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Documentation of ≥1 of the following:
  3. 1. Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR
  4. 2. Previous radiographs with bony erosions in hands or feet consistent with RA
  5. * Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to one of the following:
  6. 1. ≥1 csDMARD treatment; OR
  7. 2. 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
  8. * Moderate-to-severely active axSpA defined by BOTH of the following at Screening AND Day 1:
  9. 1. BASDAI ≥4, AND
  10. 2. Back pain ≥4 (from BASDAI Item 2)
  11. * 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 one of the following:
  12. 1. 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; OR
  13. 2. 1 bDMARD (anti-TNF or anti-IL-17) or 1 tsDMARD treatment at an approved dose for ≥12 weeks (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
  14. * Day 1 TJC ≥3 out of 68 and SJC ≥3 out of 66 (dactylitis counts as 1 joint each)
  15. * ≥1 active plaque psoriasis lesion and/or a documented history of psoriasis
  16. * In adequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to one of the following:
  17. 1. ≥1 NSAID treatment; AND
  18. 2. ≥1 csDMARD treatment; OR
  19. 3. 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
  1. * Inadequate response to ≥2 or more bDMARDs and/or tsDMARDs
  2. * Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072

Contacts and Locations

Study Contact

SKYWAY-RD Trial Center
CONTACT
+1-650-402-3164
info@skyway-rd.com

Principal Investigator

SKYWAY-RD Study Director
STUDY_DIRECTOR
Spyre Therapeutics

Study Locations (Sites)

Site 101
Brookline, Massachusetts, 02446
United States
Site 103
Tomball, Texas, 77375
United States
Site 102
Tomball, Texas, 77377
United States

Collaborators and Investigators

Sponsor: Spyre Therapeutics, Inc.

  • SKYWAY-RD Study Director, STUDY_DIRECTOR, Spyre Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-21
Study Completion Date2028-03-27

Study Record Updates

Study Start Date2025-08-21
Study Completion Date2028-03-27

Terms related to this study

Additional Relevant MeSH Terms

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