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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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:

‣ Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR

⁃ 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 csDMARD treatment; OR

⁃ 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:

‣ BASDAI ≥4, AND

⁃ 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:

‣ 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; OR

⁃ 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 NSAID treatment; AND

⁃ ≥1 csDMARD treatment; OR

⁃ 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)

Locations
United States
California
Site 114
RECRUITING
Chula Vista
Site 111
RECRUITING
Covina
Site 108
RECRUITING
Tujunga
Site 112
RECRUITING
Upland
Massachusetts
Site 101
RECRUITING
Brookline
Pennsylvania
Site 104
RECRUITING
Duncansville
Texas
Site 102
RECRUITING
Tomball
Site 103
RECRUITING
Tomball
Contact Information
Primary
SKYWAY-RD Trial Center
info@skyway-rd.com
+1-650-402-3164
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 285
Treatments
Experimental: Rheumatoid Arthritis, Dose Regimen 1
Participants will receive double-blind dosing regimen 1 of SPY072
Experimental: Rheumatoid Arthritis, Dose Regimen 2
Participants will receive double-blind dosing regimen 2 of SPY072
Experimental: Psoriatic Arthritis
Participants will receive double-blind dose of SPY072
Experimental: Axial Spondyloarthritis
Participants will receive double-blind dose of SPY072
Placebo_comparator: Rhematoid Arthritis Placebo
Participants will receive matching placebo
Placebo_comparator: Psoriatic Arthritis Placebo
Participants will receive matching placebo
Placebo_comparator: Axial Spondyloarthritis Placebo
Participants will receive matching placebo
Sponsors
Leads: Spyre Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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