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SPY002-072

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment285
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07148414A Study of SPY072 in Rheumatic DiseasePHASE2 ACTIVE NOT_RECRUITING 285Aug 21, 2025Mar 31, 2028Jun 5, 202664 United States, Bulgaria +6
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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.

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
Interventions
NameTypeDescription
SPY002-072DRUGExperimental
PlaceboDRUGMatching Placebo
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Eligibility Criteria
Age Range18 Years — 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 StatesBulgariaCzechiaGeorgiaMoldovaPolandSpainUkraine
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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, 2026NCT07148414primaryCompletionDate: changed
LOWMay 24, 2026NCT07148414studyFirstPostDate: changed