BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05314517 (Namilumab in Chronic Pulmonary Sarcoidosis): BVCT ex-ante prediction vs. reported outcome

On 21 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 3 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
NCT05314517
Acronym
RESOLVE-Lung
Drug Name
Namilumab
Drug MoA
anti-GM-CSF mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Chronic Pulmonary Sarcoidosis
Human Patients
107
Sponsor
Roivant Sciences
Phase
Phase 2

Prediction of , index 1763

Prospective Prediction
Prediction Index
1763
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in sarcoidosis worsening inferior to oral corticosteroid)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in sarcoidosis worsening against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
104 days in advance
Readout Data Interpretation
namilumab failed to achieve the primary efficacy endpoint
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, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis
Phase
Phase 2
Status
Terminated
Enrollment
107
Lead sponsor
Kinevant Sciences GmbH
Conditions
Sarcoidosis, Pulmonary
Interventions
DRUG: Namilumab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-08-31
Primary completion
2024-10-16
Completion
2025-04-09
Results first posted
2025-09-12
Primary outcomes
  • Percentage of Participants With a Rescue Event During the DB Period (Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.)

NCT05314517 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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