← Back to Search

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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Itch
Secondary study objectives
Occurrence of Adverse Events during Dupilumab Treatment

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
12%
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~11960

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,485 Total Patients Enrolled
3 Trials studying Skin Diseases
2,033 Patients Enrolled for Skin Diseases
Amy PallerPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
1,710 Total Patients Enrolled
1 Trials studying Skin Diseases
1,666 Patients Enrolled for Skin Diseases

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05649098 — Phase < 1
Skin Diseases Research Study Groups: Open-Label Dupilumab
Skin Diseases Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05649098 — Phase < 1
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05649098 — Phase < 1
~7 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top