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Monoclonal Antibodies

Dupilumab for Hives (CUPID Trial)

Phase 3
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study A and C: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
Participants who have a diagnosis of CSU refractory to H1 antihistamines (H1-AH) at the time of randomization defined by:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 and week 24
Awards & highlights

CUPID 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.Check my eligibility
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.See study design
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.

CUPID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have never taken omalizumab for Study A and C, or I did not respond well to it for Study B.
Select...
My chronic hives do not improve with standard allergy medications.
Select...
I am taking a specific antihistamine for chronic hives as part of this study.
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.
Select...
I have been diagnosed with chronic spontaneous urticaria for more than 6 months.
Select...
In the last week, I have...
Select...
I have had itch and hives for more than 6 weeks despite taking antihistamines.

CUPID Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Medical Device Site Haemorrhage
8%
Myalgia
8%
Limb Injury
4%
Medical Device Site Pain
4%
Food Poisoning
4%
Anxiety
4%
Petechiae
4%
Pain In Extremity
4%
Medical Device Site Erythema
4%
Abdominal Pain
4%
Covid-19
4%
Medical Device Site Urticaria
4%
Blood Pressure Abnormal
4%
Tooth Abscess
4%
Upper Respiratory Tract Infection
4%
Dental Restoration Failure
4%
Dermatitis
4%
Back Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteer
Atopic Dermatitis Patients

CUPID 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
~2070

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,160 Previous Clinical Trials
3,514,078 Total Patients Enrolled
3 Trials studying Chronic Urticaria
257 Patients Enrolled for Chronic Urticaria
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,361 Total Patients Enrolled
1 Trials studying Chronic Urticaria
24 Patients Enrolled for Chronic Urticaria
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,571 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the results of prior clinical trials involving Dupilumab SAR231893?

"Dupilumab SAR231893 was first studied in 2015 at the Regeneron Investigational Site. So far, there have been a completed 18270 studies. There are 53 trials that are still recruiting patients, many of which are located in Saint Louis, Missouri."

Answered by AI

Is this specific research being conducted at various locations across North America?

"In addition to 44 other sites, this research is taking place at Investigational Site Number 8400009 in Saint Louis, Missouri, Investigational Site Number 8400020 in Owensboro, Kentucky, and Investigational Site Number 8400008 in Rochester, New york."

Answered by AI

What is the size of the sample group for this clinical trial?

"Although this study was posted on December 11th, 2019 and updated on June 14th, 2022, it is not currently searching for patients. There are, however, 37 other trials for chronic urticaria and 53 trials for Dupilumab SAR231893 that are actively enrolling participants."

Answered by AI

What is the precedent for this kind of clinical research?

"Dupilumab SAR231893 has been under investigation since 2015. The first clinical trial was completed in 2015 and was sponsored by Sanofi. After the first study in 2015, which involved 880, Dupilumab SAR231893 received its Phase 3 drug approval. Currently, there are 53 active trials for Dupilumab SAR231893 across 455 cities and 43 countries."

Answered by AI

What is the central purpose of this research?

"The main objective of this study, as measured over a Baseline to Week 24 interval, is to see the Change from baseline in weekly itch severity score (except EU and EU reference countries). Additionally, this study will also be measuring secondary outcomes like the Proportion of ISS7 MID (≥5 points) responders which is defined as Proportion of ISS7 MID (≥5 points) responders at Week 12 and Week 24., Change from baseline in ISS7 at all time points which is defined as Change from baseline in ISS7 at all time points (onset of action is assessed by the first p<0.05"

Answered by AI

What are the primary conditions that Dupilumab SAR231893 has been known to improve?

"Dupilumab SAR231893 is most commonly used for atopic dermatitis. However, it has also been found to be an effective treatment for corticosteroid-resistant conditions like eosinophil and asthma."

Answered by AI

Is this research project available to adults who are 18 years and older?

"According to the age requirements set out in this clinical trial's inclusion criteria, the youngest a patient can be is 6 years old and the eldest is 80."

Answered by AI

Would it be possible to enroll in this clinical study at this time?

"The research team is no longer recruiting patients for this study, as reflected on clinicaltrials.gov. This study was first posted on December 11th, 2019 and was last updated on June 14th, 2020. Out of the 91 active studies, this is the only one that is not recruiting patients."

Answered by AI

Has the FDA cleared Dupilumab SAR231893 for use?

"There is robust evidence from Phase 3 clinical trials to support the safety of Dupilumab SAR231893."

Answered by AI

Which type of patient does this clinical trial require?

"Eligible patients for this trial include anyone with chronic urticaria aged between 6 and 80. A total of 384 patients will be admitted to the study."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Investigational Site Number 1240002
What portion of applicants met pre-screening criteria?
Did not meet criteria
~73 spots leftby Mar 2025