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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.
Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient global impression of severity (PGIS) of pruritus scored "severe" at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 36
Awards & highlights
Study Summary
This trial is testing a new drug, dupilumab, to see if it is safe and effective in treating adults with chronic pruritus of unknown origin (CPUO). The trial has two parts, study A and study B. In both parts, participants will use a non-sedative antihistamine and an emollient for 4 weeks before starting the trial medication. In study A, participants will be treated with dupilumab or placebo for 24 weeks, followed by a 12-week follow-up period. In study B, participants will be treated with dupilumab or placebo for 12 weeks, followed by a 12
Who is the study for?
Adults aged 18-90 with severe, chronic itching of unknown origin that affects at least two body areas (legs, arms, or trunk) and have not found relief from previous treatments. Participants must score 'severe' on itch severity scales and be in good health otherwise. Those with certain infections, immune deficiencies, severe kidney failure, hypersensitivity to antihistamines or a history of cancer within the last five years are excluded.Check my eligibility
What is being tested?
The trial is testing Dupilumab's effectiveness for treating chronic itching without a known cause over a period of either 12 or 24 weeks. It involves two parallel studies where participants also use non-sedative antihistamines and moisturizers. They're randomly assigned to receive either Dupilumab or a placebo in addition to their current regimen.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, common side effects of Dupilumab may include injection site reactions (like redness), eye inflammation or irritation, cold sores in your mouth or throat area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 90 years old.
Select...
I have severe itching with a score of 7 or more and consider my itching to be severe.
Select...
My severe itching has not improved with past treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
Secondary outcome measures
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12
+30 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
OLE Period: Placebo/Dupilumab
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment3 Interventions
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer
Group II: PlaceboPlacebo Group3 Interventions
Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moisturizer
2008
Completed Phase 4
~300
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,772 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer, except for certain skin cancers or cervical cancer that's been fully treated, in the last 5 years.My worst itch score has been 7 or more for the past two weeks.I am between 18 and 90 years old.I have not needed antibiotics or antivirals for an infection in the last 2 weeks.I have severe itching with a score of 7 or more and consider my itching to be severe.I might have a parasite infection or have taken antiparasitic drugs recently.I have previously participated in a dupilumab study or used dupilumab.I have had chronic itching for at least 6 months.I do not have active tuberculosis or a history of untreated TB, or I have been cleared by a specialist to start treatment.I am receiving the best treatment for conditions like diabetes that could affect my itching.My severe itching has not improved with past treatments.I have long-term itching with no known cause.I have long-term itching on at least two of these: legs, arms, or trunk.I am HIV positive.I am on dialysis for severe kidney failure.You have had a bad reaction or can't tolerate non-sedative antihistamines.You have a weakened immune system or are suspected to have one.You reported severe itching on Day 1.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are currently enrolled in this research?
"The sponsor, Sanofi, needs to recruit 208 eligible patients from clinical trial sites like Dawes Fretzin Clinical Research Group, LLC-Site Number:8400007 in Indianapolis, Indiana and Nebraska Medical Research Institute, Inc.-Site Number:8400014 in Bellevue, Nebraska."
Answered by AI
Does the age limit for this study extend beyond 60 years old?
"3 studies are for patients who are not old enough to qualify for this trial and 26 are for patients who are too old."
Answered by AI
Is this trial being run at many locations across North America?
"There are 21 sites currently running this study, for example Dawes Fretzin Clinical Research Group, LLC-Site Number:8400007 in Indianapolis, Nebraska Medical Research Institute, Inc.-Site Number:8400014 in Bellevue, and National Allergy, Asthma & Urticaria Centers of Charleston, PA-Site Number:8400032 in North Charleston."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Skin Care Physicians of Georgia-Site Number:8400030
What portion of applicants met pre-screening criteria?
Did not meet criteria
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