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NCT04455841 (INCB000928 in Anemia Due to Myeloproliferative Disorders): BVCT ex-ante prediction vs. reported outcome

On 6 Feb 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 12 Dec 2024 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
NCT04455841
Drug Name
INCB000928
Drug MoA
anti-ALK2/ACVR1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Hemic and Lymphatic Diseases
Indication
Anemia Due to Myeloproliferative Disorders
Human Patients
84
Sponsor
Incyte Corporation
Phase
Phase 1 Phase 2

Prediction of , index 1451

Prospective Prediction
Prediction Index
1451
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in anemia response) partial FAILURE (statistically insignificant additive clinical benefit in PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
310 days in advance
Readout Data Interpretation
INCB000928 + ruxolitinib failed to improve anemia in MF patients
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 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
84
Lead sponsor
Incyte Corporation
Conditions
Anemia; Post-essential Thrombocythemia Myelofibrosis; Post-polycythemia Vera Myelofibrosis
Interventions
DRUG: INCB000928; DRUG: ruxolitinib
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2021-03-19
Primary completion
2025-04-01
Completion
2027-11-26
Results first posted
2026-05-12
Primary outcomes
  • Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE) (up to approximately 4 years)
  • Number of Participants With Any ≥Grade 3 TEAE and Any Treatment-emergent SAE (up to approximately 4 years)
  • Number of Participants With Dose-limiting Toxicities (DLTs) (from Cycle 1 Day 1 to Cycle 1 Day 28)
  • Maximum Tolerated Dose (MTD) (from Cycle 1 Day 1 to Cycle 1 Day 28)
  • Recommended Dose for Expansion (RDE) (from Cycle 1 Day 1 to Cycle 1 Day 28)

NCT04455841 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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