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NCT04717414 (Luspatercept in Myelofibrosis-Associated Anemia): BVCT ex-ante prediction vs. reported outcome

On 19 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 18 Jul 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04717414
Acronym
INDEPENDENCE
Drug Name
Luspatercept
Drug MoA
recombinant fusion protein ActRIIB/ACVR2B ligand trap
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Hemic and Lymphatic Diseases
Indication
Myelofibrosis-Associated Anemia
Human Patients
313
Sponsor
Bristol-Myers Squibb
Phase
Phase 3

Prediction of , index 1935

Prospective Prediction
Prediction Index
1935
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit to concomitant JAK2 inhibitors in RBC-TI proportion for >=8 weeks)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit to concomitant JAK2 inhibitors in RBC-TI proportion for >=8 weeks compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
149 days in advance
Readout Data Interpretation
Luspatercept failed to achieve the primary endpoint of RBC transfusion independence (p=0.0674)
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal disease model of RBC-transfusion-requiring anaemia associated with myeloproliferative neoplasm-associated myelofibrosis that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions
Phase
Phase 3
Status
Active not recruiting
Enrollment
313
Lead sponsor
Celgene
Conditions
Myeloproliferative Disorders; Myelofibrosis; Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Anemia
Interventions
DRUG: ACE-536; OTHER: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2021-02-25
Primary completion
2025-05-26
Completion
2032-08-18
Results first posted
2026-07-16
Primary outcomes
  • Red Blood Cell-transfusion Independence (RBC-TI) ≥ 12 Weeks (RBC-TI 12) (From randomization to week 36 (Approximately 36 Weeks))

NCT04717414 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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