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NCT05320198 (DISC-0974 in Anemia): BVCT ex-ante prediction vs. reported outcome

On 5 Oct 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 14 Jun 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (superior efficacy compared with SoC and numerically superior to Luspatercept).

Clinical Trial

NCTID
NCT05320198
Acronym
RALLY-MF
Drug Name
DISC-0974
Drug MoA
hemojuvelin mAb inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Hemic and Lymphatic Diseases
Indication
Anemia
Human Patients
56
Sponsor
Disc Medicine
Phase
Phase 1 Phase 2

Prediction of , index 1024

Prospective Prediction
Prediction Index
1024
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
253 days in advance
Readout Data Interpretation
55% TI vs 32% for decitabine vs 50% achieved by Luspatercept in phase 3 BELIEVE trial NCT02604433.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (superior efficacy compared with SoC and numerically superior to Luspatercept)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
RALLY-MF: A Phase 1b/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of DISC-0974 in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
150
Lead sponsor
Disc Medicine, Inc
Conditions
Myelofibrosis; Anemia; Anemia; Myelofibrosis; Myelofibrosis Due to and Following Polycythemia Vera; Primary Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Myelodysplastic Syndromes
Interventions
DRUG: DISC-0974
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2022-06-06
Primary completion
2027-05
Completion
2027-06
Primary outcomes
  • Safety and Tolerability of DISC-0974 (Phase 1b only) (From Day 1 to the end of treatment on Day 169)
  • Safety and Tolerability of DISC-0974 (Phase 1b only) (From Day 1 to the end of treatment on Day 169)
  • Safety and Tolerability of DISC-0974 (Phase 1b only) (From Day 1 to the end of treatment on Day 169)
  • Safety and Tolerability of DISC-0974 (Phase 1b only) (From Day 1 to the end of treatment on Day 169)
  • Safety and Tolerability of DISC-0974 assessed through blood testing (Phase 1b only) (From Day 1 to the end of treatment on Day 169)

NCT05320198 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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