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NCT04681729 · ClinicalTrials.gov registry record · Phase 3
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 82
- Enrollment target
NCT04681729: Completed Phase 3 study, sponsored by Sanofi.
NCT04681729 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 82 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04681729, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 82 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine Secondary Objectives: To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease control To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU local signs and symptoms (hives/wheals, itch, burning sensation and pain) after provocation test To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease activity To demonstrate improvement in health-related quality-of-life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of participants who require rescue therapy To evaluate the proportion of participants with cold exposure triggered urticaria To evaluate safety outcome measures To evaluate immunogenicity of dupilumab
Primary Outcome
The ice cube provocation test is the most frequently used provocation method for cold urticaria (ColdU). A negative ice cube provocation test was defined as the absence of confluent hives/wheal at the entire skin site of exposure after ice cube provocation test. Ice cube was applied on forearm skin for 5 minutes. Provocation test reading time was 10 minutes after removal of ice cube.
Interventions
- DRUG Placebo
- DRUG Dupilumab SAR231893
- DRUG Non sedating H1-antihistamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2023-04-20 |
| Phase | Phase 3 |
What the finished NCT04681729 record still lists
NCT04681729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04681729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04681729 about?
NCT04681729 is a clinical study titled "Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)". Primary Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine Secondary Objectives: To demonstrate the efficacy of dupilumab on primary a...
What is the current status of trial NCT04681729?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 82 participants. The study started on 2020-12-10. Estimated completion is 2023-04-20.
What interventions are being tested in trial NCT04681729?
The interventions under investigation include: Placebo (DRUG), Dupilumab SAR231893 (DRUG), Non sedating H1-antihistamine (DRUG).
Who is sponsoring clinical trial NCT04681729?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04681729's enrollment target sits among peer trials
82 1752nd of 2000 higher than 249 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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