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A Study of SPY072 in Rheumatic Disease

Active Not RecruitingPhase 2

Sponsor: Spyre Therapeutics, Inc.

Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Rheumatic Diseases, Rheumatic Joint Disease

Interventions: SPY002-072, Placebo

Countries: United States, Bulgaria, Czechia, Georgia, Moldova, Poland, Spain, Ukraine

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Avondale, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Covina, California, United States
Tujunga, California, United States
Upland, California, United States
Whittier, California, United States
Aventura, Florida, United States
Hialeah, Florida, United States
Ormond Beach, Florida, United States
Tampa, Florida, United States
Willowbrook, Illinois, United States
Rockville, Maryland, United States
Duncansville, Pennsylvania, United States
Corpus Christi, Texas, United States
Irving, Texas, United States
Tomball, Texas, United States
Tomball, Texas, United States
Lovech, Lovech, Bulgaria
Pleven, Pleven, Bulgaria
Plovdiv, Plovdiv, Bulgaria
Plovdiv, Plovdiv, Bulgaria
Varna, Varna, Bulgaria
Hlučín, Hlučín, Czechia
Moravská Ostrava, Ostrava-město, Czechia
Pardubice, Pardubice Region, Czechia
Prague, Praha, Hlavní Mesto, Czechia
Prague, Praha, Hlavní Mesto, Czechia
Uherské Hradiště, Zlín, Czechia
Tbilisi, K'alak'i T'bilisi, Georgia
+ 34 more on CT.gov