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NCT04180488 (dupilumab in chronic spontaneous urticaria): BVCT ex-ante prediction vs. reported outcome

On 10 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 10 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to both omalizumab an barzolvolimab).

Clinical Trial

NCTID
NCT04180488
Acronym
LIBERTY-CSU CUPID
Drug Name
dupilumab
Drug MoA
anti-IL4 and anti-IL13 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
chronic spontaneous urticaria (CSU)
Human Patients
397
Sponsor
Sanofi
Phase
Phase 3

Prediction of , index 1740

Prospective Prediction
Prediction Index
1740
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in ISS7/UAS7 inferior to both omalizumab and barzolvolimab in biologic-naïve refractory CSU patients)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in ISS7/UAS7 against placebo in biologic-naïve refractory CSU patients)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
31 days in advance
Readout Data Interpretation
dupilumab achieved 12% placebo-adjusted CR at week 24 (p=0.02) vs. 31% placebo-adjusted CR at week 12 achieved by barzolvolimab in NCT05368285 vs 27% placebo-adjusted CR at week 12 achieved by omalizumab in ASTERIA I study.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to both omalizumab an barzolvolimab)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab
Phase
Phase 3
Status
Completed
Enrollment
397
Lead sponsor
Sanofi
Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG: Dupilumab SAR231893; DRUG: Placebo; DRUG: non sedating H1-antihistamine
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-12-11
Primary completion
2024-08-01
Completion
2024-10-25
Results first posted
2025-08-20
Primary outcomes
  • Change From Baseline in Weekly Itch Severity Score at Week 24 (Baseline (Day 1) and Week 24)

NCT04180488 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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