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NCT06049017 (icotrokinra in Moderately to Severely Active Ulcerative Colitis): BVCT ex-ante prediction vs. reported outcome

On 14 Jan 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 10 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to PRA023).

Clinical Trial

NCTID
NCT06049017
Acronym
ANTHEM-UC
Drug Name
icotrokinra (JNJ-2113)
Drug MoA
anti-IL23R antagonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Moderately to Severely Active Ulcerative Colitis
Human Patients
252
Sponsor
Johnson & Johnson / Protagonist Therapeutics
Phase
Phase 2

Prediction of , index 1869

Prospective Prediction
Prediction Index
1869
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in clinical response/remission)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in clinical response/remission compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
55 days in advance
Readout Data Interpretation
icotrokinra achieved 20.1% placebo-adjusted clinical remission rate at week 12 (p<0.001); inferior to PRA023 (tulisokibart) that achieved 25% placebo-adjusted clinical remission rate at week 12 for UC patients (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to PRA023)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
Phase
Phase 2
Status
Completed
Enrollment
252
Lead sponsor
Janssen Research & Development, LLC
Conditions
Colitis, Ulcerative
Interventions
DRUG: JNJ-77242113; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-10-09
Primary completion
2024-09-26
Completion
2026-01-05
Primary outcomes
  • Percentage of Participants with Clinical Response at Week 12 (Week 12)

NCT06049017 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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