NCT07148414

A Study of SPY072 in Rheumatic Disease

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Spyre Therapeutics, Inc.
~285 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:SPY002-072Placebo

At a glance

Recruiting sites
0 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)
Measured over Week 12
+2 more outcomes measured
Rheumatoid Arthritis
Psoriatic Arthritis
Axial Spondyloarthritis
Rheumatic Diseases
Rheumatic Joint Disease
PsA (Psoriatic Arthritis)
AxSpA
Rheumatologic Disease
64 sites across 37 states
California5
K'alak'i T'bilisi5
Kyiv Oblast5
Florida4
Texas4
Georgia3
Arizona2
Plovdiv2
  • SKYWAY-RD Study Director · STUDY_DIRECTOR · Spyre Therapeutics

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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:
Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
Moderate-to-severely active axSpA defined by BOTH of the following at Screening AND Day 1:
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:
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:

Exclusion

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
  • Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)Week 12

    The score is calculated based on the number of tender and swollen joints out of 28 assessed (TJC28 and SJC28), a measure of inflammation in the blood (c-reactive protein, CRP), and the subject's overall assessment of their health (patient global assessment). Scores range from 0-10. Higher scores indicate greater disease activity.

  • Axial Spondyloarthritis: Change from baseline in Ankylosing Spondylitis Disease Activity Score (ADAS)Week 16

    The score combines 5 disease activity variables (back pain, duration of morning stiffness, patient global assessment of disease activity, peripheral pain/swelling and measure of inflammation) to measure disease activity. Lowest score is 0.6 and increases as disease worsens. Higher scores indicate greater disease activity.

  • Psoriatic Arthritis: Proportion of participants who achieve an American College of Rheumatology 20 Response Criteria (ACR20) responseWeek 16

    The proportion of subjects who achieve at least 20% improvement in tender and swollen joint counts (TJC and SJC), and at least 20% improvement in 3 out of 5 other disease activity measures (patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire, and measure of inflammation) will be assessed.