BioinvestGPT

BioinvestGPT ApS · Research use only

NCT06041269 (Rosnilimab in Rheumatoid Arthritis): BVCT ex-ante prediction vs. reported outcome

On 14 Nov 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 12 Feb 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (ACR50 at week 12 as the prespecified efficacy endpoint) and commercially insufficient.

Clinical Trial

NCTID
NCT06041269
Acronym
RENOIR
Drug Name
Rosnilimab
Drug MoA
PD1 mAb agonist
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Rheumatoid Arthritis
Human Patients
420
Sponsor
AnaptysBio
Phase
Phase 2

Prediction of , index 1388

Prospective Prediction
Prediction Index
1388
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
90 days in advance
Readout Data Interpretation
rosnilimab failed to achieve statistical significance in placebo-adjusted ACR50/ACR70 at week 12; inferior to upadacitinib that achieved 28% placebo-adjusted ACR50 and 21% placebo-adjusted ACR70 at week 12 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (ACR50 at week 12 as the prespecified efficacy endpoint) 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 Rheumatoid Arthritis
Phase
Phase 2
Status
Active not recruiting
Enrollment
420
Lead sponsor
AnaptysBio, Inc.
Conditions
Rheumatoid Arthritis
Interventions
DRUG: Rosnilimab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-08-31
Primary completion
2024-11-29
Completion
2025-05-30
Primary outcomes
  • Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 (Baseline to Week 12)

NCT06041269 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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