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NCT05054140 (IMU-838 in Progressive Multiple Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 14 Jan 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 30 Apr 2025 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
NCT05054140
Acronym
CALLIPER
Drug Name
IMU-838
Drug MoA
DHODH inhibitor and NURR1 activator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Progressive Multiple Sclerosis (PMS)
Human Patients
450
Sponsor
Immunic
Phase
Phase 2

Prediction of , index 1868

Prospective Prediction
Prediction Index
1868
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in EDSS/CDP inferior to tolebrutinib)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in EDSS/CDP compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
106 days in advance
Readout Data Interpretation
IMU838 failed to achieve statistically significant EDSS improvement compared with placebo
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
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Phase
Phase 2
Status
Unknown
Enrollment
450
Lead sponsor
Immunic AG
Conditions
Multiple Sclerosis
Interventions
DRUG: IMU-838; DRUG: Placebo matching IMU-838
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-09-30
Primary completion
2025-01-07
Completion
2025-01-07
Primary outcomes
  • Efficacy of IMU-838 versus placebo (120 weeks)

NCT05054140 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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