A Study of SPY072 in Rheumatic Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2028-03-31

Brief Summary

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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).

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Detailed Description

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The basket study comprises of substudies in rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and psoriatric arthritis (PsA) as follows:

* RA substudy: Moderately to severely active RA despite treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic disease modifying anti-rheumatic drugs (bDMARDs), or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs)
* axSpA substudy: Moderately to severely active axSpA despite treatment with non-steroidal anti-inflammatory drugs (NSAIDS), bDMARDs, or tsDMARDs
* PsA substudy: Moderately to severely active PsA despite treatment with NSAIDs, csDMARDs, bDMARDs, or tsDMARDs

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rheumatoid Arthritis, Dose Regimen 1

Participants will receive double-blind dosing regimen 1 of SPY072

Group Type EXPERIMENTAL

SPY002-072

Intervention Type DRUG

Experimental

Rheumatoid Arthritis, Dose Regimen 2

Participants will receive double-blind dosing regimen 2 of SPY072

Group Type EXPERIMENTAL

SPY002-072

Intervention Type DRUG

Experimental

Psoriatic Arthritis

Participants will receive double-blind dose of SPY072

Group Type EXPERIMENTAL

SPY002-072

Intervention Type DRUG

Experimental

Axial Spondyloarthritis

Participants will receive double-blind dose of SPY072

Group Type EXPERIMENTAL

SPY002-072

Intervention Type DRUG

Experimental

Rhematoid Arthritis Placebo

Participants will receive matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Psoriatic Arthritis Placebo

Participants will receive matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Axial Spondyloarthritis Placebo

Participants will receive matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Interventions

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SPY002-072

Experimental

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Other Intervention Names

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SPY072

Eligibility Criteria

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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. 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)

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 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)

For psoriatic arthritis:

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SKYWAY-RD Study Director

Role: STUDY_DIRECTOR

Spyre Therapeutics

Locations

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Site 113

Avondale, Arizona, United States

Site Status RECRUITING

Site 114

Chula Vista, California, United States

Site Status RECRUITING

Site 111

Covina, California, United States

Site Status RECRUITING

Site 108

Tujunga, California, United States

Site Status RECRUITING

Site 112

Upland, California, United States

Site Status RECRUITING

Site 107

Whittier, California, United States

Site Status RECRUITING

Site 109

Hialeah, Florida, United States

Site Status RECRUITING

Site 106

Ormond Beach, Florida, United States

Site Status RECRUITING

Site 110

Tampa, Florida, United States

Site Status RECRUITING

Site 101

Brookline, Massachusetts, United States

Site Status RECRUITING

Site 104

Duncansville, Pennsylvania, United States

Site Status RECRUITING

Site 105

Corpus Christi, Texas, United States

Site Status RECRUITING

Site 103

Tomball, Texas, United States

Site Status RECRUITING

Site 102

Tomball, Texas, United States

Site Status RECRUITING

Site 503

Lovech, Lovech, Bulgaria

Site Status RECRUITING