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NCT06953466 · ClinicalTrials.gov registry record · Phase 2
Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome
A Phase 2 study of Netherton Syndrome, sponsored by Quoin Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT06953466: Recruiting Phase 2 study of Netherton Syndrome, sponsored by Quoin Pharmaceuticals.
NCT06953466 is a Phase 2 study of Netherton Syndrome that is actively recruiting participants, run by Quoin Pharmaceuticals. The registered enrollment target is 8 participants, below the 27-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06953466, a Phase 2 study of Netherton Syndrome, is actively recruiting participants, sponsored by Quoin Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial (via an expanded access Treatment Protocol) is to learn if QRX003 (an investigational drug) applied topically to the skin (including up to the entire body \[except the scalp\]) works to treat the genetic disease Netherton syndrome. It will also learn about the safety of QRX003. The main questions the trial aims to answer are: 1. Does QRX003 impact the clinical presentation of NS in adults and minors by improving the clinical symptoms (diseased skin area, itch, and discomfort; based on clinical scoring, subject self-assessment, and other criteria)? 2. What medical problems do participants have when taking QRX003? 3. What percent of subjects will require rescue therapy? Participants will: Take drug QRX003 twice daily (applied topically to all affected areas of the body excluding the scalp) for 3 months, visit the clinic once every 4-6 weeks for checkups and tests, and to keep a dosing diary that records the times they applied the drug.
Primary Outcome
Description: Proportion of subjects with 1-point reduction on the Investigator's Global Assessment (IGA) from Baseline. The IGA assesses overall severity of a subject's NS based on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Conditions Studied
Interventions
- DRUG QRX003, 4% Lotion
Study Locations (1)
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2025-07 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 2 |
What NCT06953466 shows while recruiting
NCT06953466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 27-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Netherton Syndrome appearing as the primary indexed condition, and to 1 intervention - of which QRX003, 4% Lotion is the first listed.
NCT06953466 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06953466 about?
NCT06953466 is a clinical study titled "Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome". The goal of this clinical trial (via an expanded access Treatment Protocol) is to learn if QRX003 (an investigational drug) applied topically to the skin (including up to the entire body \[except the scalp\]) works to treat the genetic disease Netherton syndrome. It will also learn about the safety ...
What is the current status of trial NCT06953466?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2025-07. Estimated completion is 2026-07-30.
What conditions does trial NCT06953466 study?
This clinical trial studies the following conditions: Netherton Syndrome.
What interventions are being tested in trial NCT06953466?
The interventions under investigation include: QRX003, 4% Lotion (DRUG).
Who is sponsoring clinical trial NCT06953466?
This trial is sponsored by Quoin Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06953466 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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