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SPY002-072

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Spyre Therapeutics, Inc.|Last Updated: Jun 5, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment285
FDA Designations
No designations recorded
Clinical trial landscape

SPY002-072 · 2 trials · 9 indications

Phase 2 1Phase 1 1
NCT07148414A Study of SPY072 in Rheumatic DiseaseRheumatoid Arthritis
ACTIVE NOT_RECRUITING285 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of SPY072 in Rheumatic Disease
Rheumatoid ArthritisUnlock trial analytics
Study Endpoints
Primary Endpoints
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) response
Week 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.

Treatment emergent adverse events
Up to 40 weeks

Incidence, severity, and causal relationship of TEAEs

Secondary Endpoints
Rheumatoid Arthritis: Proportion of participants who achieve an ACR20 response
Week 12
Axial Spondyloarthritis: Proportion of participants who achieve an Assessment of Spondyloarthritis International Society (40% improvement) (ASAS40) response
Week 16
Psoriatic Arthritis: Change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rheumatoid Arthritis, Dose Regimen 1EXPERIMENTALParticipants will receive double-blind dosing regimen 1 of SPY072
Rheumatoid Arthritis, Dose Regimen 2EXPERIMENTALParticipants will receive double-blind dosing regimen 2 of SPY072
Psoriatic ArthritisEXPERIMENTALParticipants will receive double-blind dose of SPY072
Axial SpondyloarthritisEXPERIMENTALParticipants will receive double-blind dose of SPY072
Rhematoid Arthritis PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo
Psoriatic Arthritis PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo
Axial Spondyloarthritis PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo
SAD Cohorts, Experimental ArmEXPERIMENTALParticipants will receive a single dose of SPY002-072 in a dose escalation format
SAD Cohorts, Placebo ArmPLACEBO_COMPARATORParticipants will receive a single dose of placebo
Interventions
NameTypeDescription
SPY002-072DRUGExperimental
PlaceboDRUGMatching Placebo
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites64

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 rh...

Countries:United StatesBulgariaCzechiaGeorgiaMoldovaPolandSpainUkraineCanada
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Recent Changes (Last 90 Days)
MEDIUMJun 5, 2026NCT07148414Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT07148414Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT07148414Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT07148414Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06622070primaryCompletionDate: changed
LOWMay 26, 2026NCT07148414primaryCompletionDate: changed
LOWMay 24, 2026NCT06622070studyFirstPostDate: changed
LOWMay 24, 2026NCT07148414studyFirstPostDate: changed