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NCT05210790 (Rusfertide in Polycythemia Vera): BVCT ex-ante prediction vs. reported outcome

On 26 Oct 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 3 Mar 2025 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
NCT05210790
Acronym
VERIFY
Drug Name
Rusfertide
Drug MoA
peptide mimetic of hepcidin
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Polycythemia Vera (PV)
Human Patients
250
Sponsor
Protagonist Therapeutics
Phase
Phase 3

Prediction of , index 1015

Prospective Prediction
Prediction Index
1015
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in PROMIS Short Form score superior to both phlebotomy alone and phlebotomy + hydroxyurea/ruxolitinib)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in phlebotomy eligibility superior to both phlebotomy alone and phlebotomy + hydroxyurea/ruxolitinib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
128 days in advance
Readout Data Interpretation
rusfertide as an add-on treatment has met both the primary endpoint with 44% placebo-adjusted improvement in clinical response rate (p<0.0001) and four key secondary endpoints (phlebotomy/hematocrit control/PROMIS Fatigue SF8a/MFSAF TSS-7)
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 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera
Phase
Phase 3
Status
Active not recruiting
Enrollment
293
Lead sponsor
Protagonist Therapeutics, Inc.
Conditions
Polycythemia Vera
Interventions
DRUG: Placebo; DRUG: Rusfertide
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-04-01
Primary completion
2025-02-21
Completion
2027-06
Primary outcomes
  • Proportion of subjects achieving a response who receive rusfertide compared to placebo. (Week 20 through Week 32)

NCT05210790 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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