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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 (37) 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

⁃ 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 csDMARD treatment; AND/OR

⁃ ≤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:

‣ 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:

‣ 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 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 NSAID treatment; AND

⁃ ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (\>2 classes of bDMARDs and/or tsDMARDs is exclusionary)

Locations
United States
Arizona
Site 113
RECRUITING
Avondale
California
Site 114
RECRUITING
Chula Vista
Site 111
RECRUITING
Covina
Site 108
RECRUITING
Tujunga
Site 112
RECRUITING
Upland
Site 107
RECRUITING
Whittier
Florida
Site 109
RECRUITING
Hialeah
Site 106
RECRUITING
Ormond Beach
Site 110
RECRUITING
Tampa
Pennsylvania
Site 104
RECRUITING
Duncansville
Texas
Site 105
RECRUITING
Corpus Christi
Site 102
RECRUITING
Tomball
Site 103
RECRUITING
Tomball
Other Locations
Bulgaria
Site 503
RECRUITING
Lovech
Site 502
RECRUITING
Pleven
Site 505
RECRUITING
Plovdiv
Site 506
RECRUITING
Plovdiv
Site 504
RECRUITING
Varna
Georgia
Site 308
RECRUITING
Batumi
Site 302
RECRUITING
Kutaisi
Site 301
RECRUITING
Tbilisi
Site 303
RECRUITING
Tbilisi
Site 304
RECRUITING
Tbilisi
Site 305
RECRUITING
Tbilisi
Site 306
RECRUITING
Tbilisi
Site 307
RECRUITING
Tbilisi
Poland
Site 408
RECRUITING
Elblag
Site 406
RECRUITING
Gdynia
Site 401
RECRUITING
Krakow
Site 407
RECRUITING
Nowa Sól
Site 402
RECRUITING
Opole
Site 403
RECRUITING
Warsaw
Site 405
RECRUITING
Warszawa
Republic of Moldova
Site 201
RECRUITING
Chisinau
Site 202
RECRUITING
Chisinau
Spain
Site 602
RECRUITING
A Coruña
Site 604
RECRUITING
Chiclana De La Frontera
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