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NCT06127043 (Rosnilimab in Moderate to Severe Ulcerative Colitis): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 10 Nov 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
NCT06127043
Acronym
ROSETTA
Drug Name
Rosnilimab
Drug MoA
anti-PD1 agonist
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Moderate to Severe Ulcerative Colitis
Human Patients
132
Sponsor
AnaptysBio
Phase
Phase 2

Prediction of , index 1389

Prospective Prediction
Prediction Index
1389
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in modified Mayo score or clinical remission moderately inferior to tulisokibart)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in modified Mayo score or clinical remission compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
105 days in advance
Readout Data Interpretation
rosnilimab failed to meet the primary efficacy endpoint of modified Mayo Score (mMS) compared with placebo
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 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis
Phase
Phase 2
Status
Active not recruiting
Enrollment
132
Lead sponsor
AnaptysBio, Inc.
Conditions
Ulcerative Colitis
Interventions
DRUG: Rosnilimab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-12-04
Primary completion
2026-01
Completion
2026-05
Primary outcomes
  • Mean change in modified Mayo Score (mMs) from Baseline to Week 12 (Baseline to Week 12)

NCT06127043 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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