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NCT05683496 (lonigutamab in Thyroid Eye Disease): BVCT ex-ante prediction vs. reported outcome

On 20 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 29 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (non-superior).

Clinical Trial

NCTID
NCT05683496
Acronym
TED
Drug Name
lonigutamab
Drug MoA
IGF1R inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Thyroid Eye Disease (TED)
Human Patients
38
Sponsor
Acelyrin
Phase
Phase 1 Phase 2

Prediction of , index 1186

Prospective Prediction
Prediction Index
1186
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit non-superior to Tepezza)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
191 days in advance
Readout Data Interpretation
50% and 25% placebo-adjusted reduction in proptosis and diplopia at week 6 (vs 49% and 46% placebo-adjusted reduction in proptosis and diplopia achieved by tepezza at week 6 in similar clinical settings Douglas et al. 2020 NEJM).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (non-superior)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2, Adaptive, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of Lonigutamab in Subjects With Thyroid Eye Disease (TED)
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
31
Lead sponsor
ACELYRIN Inc.
Conditions
Thyroid Eye Disease
Interventions
DRUG: lonigutamab; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2023-02-14
Primary completion
2025-05-26
Completion
2025-05-26
Primary outcomes
  • Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) (Day 1 to Day 169)
  • Incidence and characterization of serious treatment emergent adverse events (TEAEs) (Day 1 to Day 169)

NCT05683496 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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