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Monoclonal Antibodies
Dupilumab for Itchy Skin Diseases
Phase < 1
Recruiting
Led By Amy Paller
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 104 weeks
Awards & highlights
Study Summary
This trial will test if an intervention with the drug dupilumab can reduce itching in people with genetic skin disorders, with a study period of 26 months.
Who is the study for?
This trial is for individuals over 6 months old with severe itch due to genetic skin disorders, who have an average itch score of ≥4. Participants must not have ichthyosis vulgaris as the only disorder, no recent serious infections or malignancies, and should not be on certain medications like biologics or immunosuppressants recently.Check my eligibility
What is being tested?
The study tests Dupilumab's effectiveness in reducing itch in various pruritic genetic inflammatory skin conditions. It includes a 16-week open-label phase followed by a long-term extension up to 26 months for those responding positively and willing to continue.See study design
What are the potential side effects?
While specific side effects are not listed here, Dupilumab may generally cause injection site reactions, eye problems (like dryness or inflammation), headaches, and cold sores. The safety profile will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 104 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Itch
Secondary outcome measures
Occurrence of Adverse Events during Dupilumab Treatment
Side 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
DB Period: Placebo
OLE Period: Dupilumab/Dupilumab
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-Label DupilumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
917,057 Total Patients Enrolled
3 Trials studying Skin Diseases
2,033 Patients Enrolled for Skin Diseases
Amy PallerPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
1,666 Total Patients Enrolled
1 Trials studying Skin Diseases
1,666 Patients Enrolled for Skin Diseases
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 6 months old.I can give my own consent or have someone legally allowed to do so if I'm under 18.I haven't used certain medications, including steroids or immunosuppressants, within the last 4 weeks or longer.I have had an average itchiness of 4 or more, with it reaching at least 5 at its worst in the past week.I have been diagnosed with ichthyosis vulgaris and no other inherited disorders.I haven't used dupilumab in the last 105 days.I am older than 6 months.I have a gene variant identified by testing, or I am willing to be tested.I have been diagnosed with a genetic skin disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label Dupilumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is there any availability to join the experiment?
"Evidently, clinicaltrials.gov has not listed this trial as actively recruiting patients at the moment. Launched on February 1st 2023 and last updated in December 5th 2022, applicants are no longer being accepted for enrollment. Nevertheless, 45 other investigational studies remain open to recruitment presently."
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