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NCT05517421 (Batoclimab in Thyroid Eye Disease): BVCT ex-ante prediction vs. reported outcome

On 23 Dec 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Apr 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05517421
Acronym
GO
Drug Name
Batoclimab
Drug MoA
anti-FcRn inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Eye Diseases
Indication
Thyroid Eye Disease
Human Patients
114
Sponsor
Immunovant
Phase
Phase 3

Prediction of , index 1164

Prospective Prediction
Prediction Index
1164
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in proptosis response rate moderately inferior to Tepezza)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in proptosis response rate compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
100 days in advance
Readout Data Interpretation
batoclimab did not meet primary endpoint of >=2mm proptosis responder rate at Week 24
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)
Phase
Phase 3
Status
Completed
Enrollment
114
Lead sponsor
Immunovant Sciences GmbH
Conditions
Thyroid Eye Disease
Interventions
DRUG: Batoclimab; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-11-23
Primary completion
2025-11-02
Completion
2025-11-18
Primary outcomes
  • Percentage of proptosis responders (At Week 24)

NCT05517421 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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