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Monoclonal Antibodies
Dupilumab for Itching
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
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.
Must not have
Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
HIV infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 36
Awards & highlights
Pivotal Trial
Summary
This trial tests a medication that reduces skin inflammation and itching in adults with severe, unexplained itching. It works by blocking proteins that cause these symptoms. The medication has shown promise in treating conditions like atopic dermatitis and asthma.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously participated in a dupilumab study or used dupilumab.
Select...
I am HIV positive.
Select...
I am on dialysis for severe kidney failure.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 • NCT0403336712%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Dupilumab/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
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 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
Dupilumab
2017
Completed Phase 4
~11960
Moisturizer
2008
Completed Phase 4
~300
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for itching, such as Dupilumab, work by targeting specific cytokines and immune pathways involved in inflammation and pruritus. Dupilumab inhibits IL-4 and IL-13 signaling, reducing inflammation and itch.
Other treatments, like JAK inhibitors, interfere with the JAK-STAT pathway, and anti-IL-31 antibodies block IL-31, a cytokine directly linked to itching. These mechanisms are important for patients to understand as they help in choosing the most effective treatment based on the cause of their itching.
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,924 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.