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NCT05975905 (Cibotercept in Pulmonary Arterial Hypertension): BVCT ex-ante prediction vs. reported outcome

On 13 Dec 2024, BioinvestGPT's BVCT predicted technical partial failure and commercial partial failure for this trial. The 29 May 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
NCT05975905
Acronym
TROPOS
Drug Name
Cibotercept (KER-012)
Drug MoA
fusion protein modified ActRIIB/ACVR2B ligand trap
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Pulmonary Arterial Hypertension (PAH)
Human Patients
113
Sponsor
Keros Therapeutics
Phase
Phase 2

Prediction of , index 1214

Prospective Prediction
Prediction Index
1214
Prediction Date
Commercial Prediction
partial FAILURE (commercially maybe sufficient yet very weak additive clinical benefit in 6MWD)
Technical Prediction
partial FAILURE (statistically maybe significant yet very weak additive clinical benefit in PVR with on-target toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
167 days in advance
Readout Data Interpretation
cibotercept’s further development has been discontinued probably due to insufficient benefit-risk profile
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 Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (TROPOS Study)
Phase
Phase 2
Status
Terminated
Enrollment
113
Lead sponsor
Keros Therapeutics, Inc.
Conditions
Pulmonary Arterial Hypertension
Interventions
BIOLOGICAL: Dose A KER-012; BIOLOGICAL: Dose B KER-012; BIOLOGICAL: Dose C KER-012; BIOLOGICAL: Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-10-17
Primary completion
2025-03-05
Completion
2025-03-11
Results first posted
2026-07-02
Primary outcomes
  • Change From Baseline in PVR (Pulmonary Vascular Resistance) (Baseline and Week 24)

NCT05975905 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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