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Monoclonal Antibodies

Dupilumab for Hives (CUPID Trial)

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
Participants who have a diagnosis of CSU refractory to H1 antihistamines (H1-AH) at the time of randomization defined by:
Study A and C: Participant must be ≥6 years to 80 years of age at the time of signing the informed consent
Must not have
Clearly defined underlying etiology for chronic urticarias other than CSU
Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 and week 24
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether the drug dupilumab is effective in treating people with chronic spontaneous urticaria who remain symptomatic despite using H1 antihistamines.

Who is the study for?
This trial is for people aged 6-80 with Chronic Spontaneous Urticaria (CSU) lasting over 6 months, who still have symptoms despite using H1 antihistamines. It's for those new to omalizumab, or who can't tolerate it or didn't respond well to it. Participants must be able to use an e-Diary daily and weigh more than 30 kg if adult/adolescent or more than 15 kg if a child.
What is being tested?
The study tests Dupilumab's effectiveness in CSU patients not fully helped by H1 antihistamines, comparing it against a placebo. The goal is to see if Dupilumab improves itchiness, hives, swelling (angioedema), disease control and quality of life while reducing the need for oral steroids.
What are the potential side effects?
Possible side effects include allergic reactions at the injection site, inflammation of organs like skin or gut (eczema or colitis), infections due to weakened immune defenses, headaches and eye problems such as conjunctivitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My chronic hives do not improve with standard allergy medications.
Select...
I am between 6 and 80 years old.
Select...
I am between 6 and 80 years old.
Select...
My chronic hives do not improve with standard allergy medications.
Select...
I am between 12 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My chronic hives have a known cause that is not chronic spontaneous urticaria.
Select...
I have or might have a parasite infection.
Select...
I do not have active tuberculosis or a related infection, or if I had it, it's been fully treated.
Select...
I weigh under 30 kg as an adult or adolescent, or under 15 kg if I'm 6-12 years old.
Select...
I have previously participated in a dupilumab study or have been treated with dupilumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in weekly itch severity score (except EU and EU reference countries)
For EU and EU reference countries only: change from baseline in weekly urticaria activity score
Secondary study objectives
4. Time to ISS7 minimally important (MID) (ISS7 ≥5) response
Change from baseline in ISS7
Change from baseline in ISS7 at all time points
+16 more

Side effects data

From 2021 Phase 4 trial • 52 Patients • NCT04447417
12%
Ecchymosis
8%
Limb Injury
8%
Myalgia
8%
Medical Device Site Haemorrhage
4%
Abdominal Pain
4%
Upper Respiratory Tract Infection
4%
Medical Device Site Pain
4%
Anxiety
4%
Dental Restoration Failure
4%
Petechiae
4%
Medical Device Site Urticaria
4%
Back Pain
4%
Pain In Extremity
4%
Covid-19
4%
Food Poisoning
4%
Tooth Abscess
4%
Dermatitis
4%
Medical Device Site Erythema
4%
Blood Pressure Abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteer
Atopic Dermatitis Patients

Awards & Highlights

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

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Study C DupilumabExperimental Treatment2 Interventions
dose regimens, on top of non-sedating H1-antihistamine
Group II: Study B DupilumabExperimental Treatment2 Interventions
dose regimens, on top of non-sedating H1-antihistamine
Group III: Study A DupilumabExperimental Treatment2 Interventions
dose regimens, on top of non-sedating H1-antihistamine
Group IV: Study A Matched PlaceboPlacebo Group2 Interventions
placebo, on top of non-sedating H1-antihistamine
Group V: Study B Matched PlaceboPlacebo Group2 Interventions
placebo, on top of non-sedating H1-antihistamine
Group VI: Study C Matched PlaceboPlacebo Group2 Interventions
placebo, on top of non-sedating H1-antihistamine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab SAR231893
2021
Completed Phase 4
~3010

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,204 Previous Clinical Trials
4,036,381 Total Patients Enrolled
3 Trials studying Chronic Urticaria
257 Patients Enrolled for Chronic Urticaria
Regeneron PharmaceuticalsIndustry Sponsor
668 Previous Clinical Trials
385,676 Total Patients Enrolled
1 Trials studying Chronic Urticaria
24 Patients Enrolled for Chronic Urticaria
Clinical Sciences & OperationsStudy DirectorSanofi
873 Previous Clinical Trials
2,020,454 Total Patients Enrolled
1 Trials studying Chronic Urticaria
161 Patients Enrolled for Chronic Urticaria

Media Library

Dupilumab SAR231893 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04180488 — Phase 3
Chronic Urticaria Research Study Groups: Study A Matched Placebo, Study A Dupilumab, Study B Dupilumab, Study C Dupilumab, Study B Matched Placebo, Study C Matched Placebo
Chronic Urticaria Clinical Trial 2023: Dupilumab SAR231893 Highlights & Side Effects. Trial Name: NCT04180488 — Phase 3
Dupilumab SAR231893 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04180488 — Phase 3
~67 spots leftby Nov 2025
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