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NCT04424927 (ordesekimab in Non-responsive Celiac Disease): BVCT ex-ante prediction vs. reported outcome

On 14 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 4 Feb 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
NCT04424927
Acronym
PROACTIVE
Drug Name
ordesekimab (AMG714/PRV015)
Drug MoA
anti-IL15 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Non-responsive Celiac Disease
Human Patients
226
Sponsor
Amgen / Sanofi
Phase
Phase 2

Prediction of , index 1680

Prospective Prediction
Prediction Index
1680
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in CeD PRO)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit in CeD PRO)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
205 days in advance
Readout Data Interpretation
ordesekimab failed to achieved statistical significance for primary or secondary endpoints
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 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet
Phase
Phase 2
Status
Completed
Enrollment
388
Lead sponsor
Provention Bio, a Sanofi Company
Conditions
Celiac Disease
Interventions
BIOLOGICAL: PRV-015; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-08-24
Primary completion
2024-07-30
Completion
2024-07-30
Results first posted
2025-10-20
Primary outcomes
  • Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 (Baseline (average of Day -7 to Day -1) up to Week 24)

NCT04424927 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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