Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Quoin Pharmaceuticals
Study ID
NCT06953466
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Netherton Syndrome

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QRX003, 4% Lotion — DRUG
    QRX003 Topical Lotion containing 4% active drug (serine protease inhibitor)

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
Jul 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QRX003, 4% BID
    Subjects will apply test article twice daily (BID) for 12 weeks

Primary Outcome Measure

Proportion of subjects with 1-point reduction on IGA [ Time Frame: Up to week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Oleg G Khatsenko
[email protected]
858-571-1800

Find similar trials in Chicago, IL

By research site
Northwestern Memorial Hospital· Chicago, IL

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