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NCT05581199 (Batoclimab in Active Chronic Inflammatory Demyelinating Polyneuropathy): 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
NCT05581199
Drug Name
Batoclimab
Drug MoA
anti-FcRn mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Human Patients
277
Sponsor
Immunovant Sciences
Phase
Phase 2

Prediction of , index 1166

Prospective Prediction
Prediction Index
1166
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 81% responder rate at week 12 for patients whose IgG was reduced by ≥ 70%; whereas efgartigimod achieved 67% responder rate at week 12 for all patients regardless of IgG reduction levels; no plan to seek regulatory approval for marketing batoclimab
Press Release
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 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Phase
Phase 2
Status
Terminated
Enrollment
94
Lead sponsor
Immunovant Sciences GmbH
Conditions
Chronic Inflammatory Demyelinating Polyneuropathy
Interventions
DRUG: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly; DRUG: Batoclimab 340 mg SC weekly; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2022-12-15
Primary completion
2026-07-20
Completion
2026-07-20
Primary outcomes
  • Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36 (Week 36)

NCT05581199 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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