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NCT06041568 (Imvotamab in Severe Systemic Lupus Erythematosus): BVCT ex-ante prediction vs. reported outcome

On 26 Oct 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 9 Jan 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
NCT06041568
Drug Name
Imvotamab
Drug MoA
anti-CD3 anti-CD20 T-cell engager
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Severe Systemic Lupus Erythematosus
Human Patients
17
Sponsor
IGM Biosciences
Phase
Phase 1

Prediction of , index 1807

Prospective Prediction
Prediction Index
1807
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in BICLA/SRI4)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in BICLA/SRI4 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
75 days in advance
Readout Data Interpretation
Imvotamab failed to demonstrate sufficient efficacy and further development discontinued accordingly
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 1b, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Severe Systemic Lupus Erythematosus Who Have Failed Standard Therapies
Phase
Phase 1
Status
Terminated
Enrollment
17
Lead sponsor
IGM Biosciences, Inc.
Conditions
Systemic Lupus Erythematosus; Lupus Erythematosus
Interventions
DRUG: Imvotamab
Design
Single group · None
Primary purpose
Treatment
Start
2023-08-15
Primary completion
2025-01-27
Completion
2025-01-27
Primary outcomes
  • Safety and tolerability of imvotamab (Up to Week 52)

NCT06041568 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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