RECRUITING

A Study of SPY072 in Rheumatic Disease

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).

Conditions

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

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

Study Overview

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Study Details

Study overview

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).

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

A Study of SPY072 in Rheumatic Disease

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Brookline

Site 101, Brookline, Massachusetts, United States, 02446

Tomball

Site 103, Tomball, Texas, United States, 77375

Tomball

Site 102, Tomball, Texas, United States, 77377

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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. Previous radiographs with bony erosions in hands or feet consistent with RA
  • * Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to one of the following:
  • 1. ≥1 csDMARD treatment; OR
  • 2. 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
  • * 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 one of the following:
  • 1. 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; OR
  • 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)
  • * 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
  • * In adequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to one of the following:
  • 1. ≥1 NSAID treatment; AND
  • 2. ≥1 csDMARD treatment; OR
  • 3. 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
  • * Inadequate response to ≥2 or more bDMARDs and/or tsDMARDs
  • * Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Spyre Therapeutics, Inc.,

SKYWAY-RD Study Director, STUDY_DIRECTOR, Spyre Therapeutics

Study Record Dates

2028-03-27