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NCT05649098 · ClinicalTrials.gov registry record · Early Phase 1
Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders
A Early Phase 1 study of Skin Diseases, sponsored by Northwestern University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05649098: Recruiting Early Phase 1 study of Skin Diseases, sponsored by Northwestern University.
NCT05649098 is a Early Phase 1 study of Skin Diseases that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 30 participants, below the 208-participant average among 14 other Skin Diseases trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05649098, a Early Phase 1 study of Skin Diseases, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.
Primary Outcome
The Primary Objective of this study is to determine if dupilumab changes itch across a range of pruritic genetic disorders of the skin. At least 50% of patients achieving reduction by at least 2 points in Worst Itch NRS (minimal meaningful reduction in Worst Itch is 1-2 points) We will compare the average Worst Itch NRS during an 8-week observational period (not a static single point) with the average Worst Itch NRS during the dupilumab treatment period at Weeks 9-16 on dupilumab (by which tim
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2026-06-01 |
| Phase | Early Phase 1 |
What NCT05649098 shows while recruiting
NCT05649098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 208-participant average among 14 other Skin Diseases trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Skin Diseases appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.
NCT05649098 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05649098 about?
NCT05649098 is a clinical study titled "Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders". Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to b...
What is the current status of trial NCT05649098?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2023-06-12. Estimated completion is 2026-06-01.
What conditions does trial NCT05649098 study?
This clinical trial studies the following conditions: Skin Diseases.
What interventions are being tested in trial NCT05649098?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT05649098?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05649098 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Skin Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05649098's enrollment target sits among peer trials
30 12th of 14 higher than 3 of 14 other Skin Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Skin Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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