BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05403541 (Batoclimab in generalized myasthenia gravis): BVCT ex-ante prediction vs. reported outcome

On 19 Oct 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 19 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient.

Clinical Trial

NCTID
NCT05403541
Drug Name
Batoclimab
Drug MoA
anti-FcRn mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
generalized myasthenia gravis (gMG)
Human Patients
240
Sponsor
Immunovant Sciences
Phase
Phase 3

Prediction of , index 1162

Prospective Prediction
Prediction Index
1162
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit non-superior to efgartigimod)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
151 days in advance
Readout Data Interpretation
batoclimab achieved 2 placebo-adjusted MG-ADL score reduction at week 12 (p < 0.001) ; numerically superior to efgartigimod's 1.6-1.7 placebo-adjusted MG-ADL score reduction at week 8-11 (see add'l link below) no plan to seek regulatory approval for marketing batoclimab
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient
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-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG)
Phase
Phase 3
Status
Terminated
Enrollment
233
Lead sponsor
Immunovant Sciences GmbH
Conditions
Generalized Myasthenia Gravis
Interventions
DRUG: Batoclimab 680 mg SC weekly; DRUG: Batoclimab 340 mg SC weekly; DRUG: Matching Placebo SC; DRUG: Batoclimab 340 mg SC bi-weekly
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-06-27
Primary completion
2025-01-10
Completion
2026-08-07
Primary outcomes
  • Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants (Baseline (Day 1) to Week 12)

NCT05403541 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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