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NCT06672718 (SPY002 in Ulcerative Colitis): BVCT ex-ante prediction vs. reported outcome

On 22 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 17 Jun 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD.

Clinical Trial

NCTID
NCT06672718
Drug Name
SPY002
Drug MoA
anti-TL1A inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Ulcerative Colitis
Human Patients
56
Sponsor
Spyre Therapeutics
Phase
Phase 1

Prediction of , index 1880

Prospective Prediction
Prediction Index
1880
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in clinical remission and endoscopic response inferior to MK7240/TEV574)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in clinical remission and endoscopic response compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
146 days in advance
Readout Data Interpretation
SPY002 achieved a 75-day half-life which is more than 3-fold greater than 1st-gen anti-TL1As; without >= Grade 2 TEAEs
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-091 in Healthy Participants
Phase
Phase 1
Status
Completed
Enrollment
50
Lead sponsor
Spyre Therapeutics, Inc.
Conditions
Healthy
Interventions
DRUG: SPY002-091; OTHER: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Basic science
Start
2024-11-26
Primary completion
2026-08-19
Completion
2026-08-19
Primary outcomes
  • Treatment emergent adverse events (Up to 40 weeks)

NCT06672718 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials