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NCT05499130 (duvakitug in Severe Ulcerative Colitis and Crohn's Disease): BVCT ex-ante prediction vs. reported outcome

On 27 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 17 Dec 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05499130
Acronym
RELIEVE UCCD
Drug Name
duvakitug (TEV’574/SAR447189)
Drug MoA
anti-TL1A mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Severe Ulcerative Colitis and Crohn's Disease
Human Patients
290
Sponsor
Teva Pharmaceuticals / Sanofi
Phase
Phase 2

Prediction of , index 1701

Prospective Prediction
Prediction Index
1701
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in clinical remission and endoscopic response non-superior and non-inferior to PRA023)
Technical Prediction
SUCCESS (statistically significant clinical benefit in clinical remission and endoscopic response against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
143 days in advance
Readout Data Interpretation
duvakitug (high-dose) achieved 27.4% placebo-adjusted clinical remission rate at week 14 (p=0.003) for UC patients; numerically superior to PRA023 that achieved 25% placebo-adjusted clinical remission rate at week 12 for UC patients; duvakitug (high-dose) achieved 34.8% placebo-adjusted clinical remission rate at week 14 (p<0.001) for CD patients; numerically superior to PRA023 that achieved 33.1% placebo-adjusted clinical remission rate at week 12 for CD patients (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)
Phase
Phase 2
Status
Completed
Enrollment
290
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions
Crohn Disease; Colitis, Ulcerative
Interventions
DRUG: TEV-48574; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-09-30
Primary completion
2024-11-12
Completion
2024-11-12
Results first posted
2025-12-05
Primary outcomes
  • Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS (Week 14)
  • Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD (Baseline to Week 14)

NCT05499130 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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