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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.
CUPID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCUPID Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 52 Patients • NCT04447417CUPID Trial Design
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- My chronic hives have a known cause that is not chronic spontaneous urticaria.I have never taken omalizumab for Study A and C, or I did not respond well to it for Study B.You have ongoing eczema.I have never taken omalizumab for Study A and C, or I did not respond well to it for Study B.I have or might have a parasite infection.I am not currently on antibiotics or antivirals for an infection.My chronic hives do not improve with standard allergy medications.I am taking a specific antihistamine for chronic hives as part of this study.I have skin conditions that could affect the study's outcome.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were fully treated.This criterion is unclear without additional context. Can you provide more information or clarify the terms "UAS7" and "ISS7"?I do not have active tuberculosis or a related infection, or if I had it, it's been fully treated.I weigh under 30 kg as an adult or adolescent, or under 15 kg if I'm 6-12 years old.I am between 6 and 80 years old.I was diagnosed with chronic spontaneous urticaria more than 6 months ago.I am between 6 and 80 years old.I am taking a specific antihistamine for chronic hives as part of this study.My chronic hives do not improve with standard allergy medications.I am between 12 and 80 years old.I have been diagnosed with chronic spontaneous urticaria for more than 6 months.There's not enough context to accurately summarize this criterion. Can you please provide more information or clarify what "UAS7" and "ISS7" stand for?I have previously participated in a dupilumab study or have been treated with dupilumab.In the last week, I have...You have a weakened immune system.You have had a severe allergic reaction to omalizumab or any similar medication in the past.I have had itch and hives for more than 6 weeks despite taking antihistamines.
- Group 1: Study A Matched Placebo
- Group 2: Study A Dupilumab
- Group 3: Study B Dupilumab
- Group 4: Study C Dupilumab
- Group 5: Study B Matched Placebo
- Group 6: Study C Matched Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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"
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."
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."
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."
Has the FDA cleared Dupilumab SAR231893 for use?
"There is robust evidence from Phase 3 clinical trials to support the safety of Dupilumab SAR231893."
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."
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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