BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04128579 (EQ001 in Systemic Lupus Erythematosus With or Without…): BVCT ex-ante prediction vs. reported outcome

On 18 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 1 Apr 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04128579
Acronym
EQUALISE
Drug Name
EQ001 (Itolizumab)
Drug MoA
anti-CD6 mAb inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Human Patients
55
Sponsor
Equillium
Phase
Phase 1

Prediction of , index 845

Prospective Prediction
Prediction Index
845
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
43 days in advance
Readout Data Interpretation
80% ORR in UPCR.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
Phase
Phase 1
Status
Completed
Enrollment
52
Lead sponsor
Biocon Limited
Conditions
Lupus Erythematosus; Lupus Nephritis
Interventions
DRUG: Itolizumab [Bmab 600]
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2019-10-01
Primary completion
2023-11-16
Completion
2024-01-18
Results first posted
2025-04-18
Primary outcomes
  • Number of Treatment Emergent Adverse Events (Type A up to Day 57 or Type B up to Day 253)

NCT04128579 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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