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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 82 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04681729
The ClinicalTrials.gov registry entry for NCT04681729 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04681729 reports 0 study locations.
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.
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