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Monoclonal Antibodies

Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first imp administration (day 1) up to 14 weeks after last imp administration (i.e., up to week 36)
Awards & highlights
Pivotal Trial

Summary

This trial is testing the effectiveness of dupilumab on reducing symptoms of ColdU, a chronic inducible cold urticaria, in participants who remain symptomatic despite the use of an H1-antihistamine.

Eligible Conditions
  • Cold Urticaria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first imp administration (day 1) up to 14 weeks after last imp administration (i.e., up to week 36)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first imp administration (day 1) up to 14 weeks after last imp administration (i.e., up to week 36) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Negative Ice Cube Provocation Test at Week 24
Secondary study objectives
Change From Baseline in Cold Urticaria Quality of Life (ColdU-QoL) Scale Score at Week 24
Change From Baseline in Cold Urticaria Signs and Symptoms Severity Scale Score at Week 24
Change From Baseline in Health-related Quality-of-life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) Scale Scores at Week 24
+13 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment2 Interventions
Dose regimens, on top of regular or as needed non-sedating H1-antihistamine
Group II: Matched PlaceboPlacebo Group2 Interventions
Placebo, on top of regular/as needed non-sedating H1-antihistamine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Non sedating H1-antihistamine
2020
Completed Phase 3
~90
Dupilumab SAR231893
2021
Completed Phase 4
~3010

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,998 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,761 Total Patients Enrolled
2 Trials studying Cold Urticaria
124 Patients Enrolled for Cold Urticaria
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,580 Total Patients Enrolled
~16 spots leftby Dec 2025
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