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SPY002-072

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Spyre Therapeutics, Inc.|Trials Updated: Oct 19, 2026

SPY002-072 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Oct 2024

SPY002-072 target and mechanism

Molecular targetTL1A
Target classProtein
ModalitySmall molecule

Also known as SPY072

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment435

FDA Designations

No designations recorded

SPY002-072 clinical trials

SPY002-072 · 2 trials · 9 indications

Phase 2 2
NCT07766005A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)Hidradenitis Suppurativa (HS)
RECRUITING150 Analytics
NCT07148414A Study of SPY072 in Rheumatic DiseaseRheumatoid Arthritis
ACTIVE NOT_RECRUITING285 Analytics
PHASE2RECRUITING
A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)
Hidradenitis Suppurativa (HS)Unlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of SPY072 in Rheumatic Disease
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Week 16

HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count

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

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Week 16
Treatment-emergent Adverse Events (TEAEs)
Up to 52 weeks
Rheumatoid Arthritis: Proportion of participants who achieve an ACR20 response
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SPY072 + bimekizumabEXPERIMENTALParticipants receive SPY072 + bimekizumab
Placebo + bimekizumabPLACEBO_COMPARATORParticipants receive matching placebo for SPY072 + bimekizumab
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
SPY072DRUGSolution for SC injection
PlaceboDRUGMatching placebo for SC injection
bimekizumabDRUGAdvanced standard of care
SPY002-072DRUGExperimental
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Clinical diagnosis of Hidradenitis Suppurativa with symptoms for at least 6 months before screening. * Hidradenitis suppurativa lesions in at least 2 distinct anatomical areas, with at least 1 area meeting Hurley Stage II or III criteria at screening and Day 1. * Total abscess...

Countries:United StatesCanadaBulgariaCzechiaGeorgiaMoldovaPolandSpainUkraine
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Recent Changes (Last 90 Days)

LOWOct 19, 2026NCT07766005Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 19, 2026NCT07766005Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 19, 2026NCT07766005Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 14, 2026NCT07766005NEW_TRIAL: changed
LOWAug 14, 2026NCT07766005NEW_TRIAL: changed

Frequently asked questions about SPY002-072

What is SPY002-072 used for?

SPY002-072 is an investigational small molecule being developed for rheumatoid arthritis and other rheumatic diseases, including psoriatic arthritis and axial spondyloarthritis. It is in Phase 2 clinical development and has not been approved for any indication.

What does SPY002-072 target?

SPY002-072 targets TL1A, a protein that plays a role in inflammatory signaling. By targeting TL1A, the drug aims to reduce inflammation associated with rheumatoid arthritis and related rheumatic conditions.

Who is developing SPY002-072?

SPY002-072 is being developed by Spyre Therapeutics, Inc., which trades under the ticker SYRE. The company is advancing the drug as part of its immunology pipeline.

What phase is SPY002-072 in?

SPY002-072 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is evaluating its potential in rheumatoid arthritis and other rheumatic diseases.

What clinical trials is SPY002-072 in?

SPY002-072 is being studied in a Phase 2 trial, NCT07148414, titled "A Study of SPY072 in Rheumatic Disease." The trial is active but not recruiting, with an enrollment of 285 participants across multiple countries including the United States, Bulgaria, Czechia, Georgia, Moldova, Poland, Spain, and Ukraine.