Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as QRX003-2% Lotion, QRX003-2%, QRX003-4% Lotion QAM, QRX003-4% QAM, QRX003-4% Lotion BID, QRX003-4%
QRX003 · 4 trials · 1 indication
The IGA (Investigator Global Assessment) is a 5-point scale used to assess the overall severity of a Subject's NS condition.
Proportion of subjects with 2-point reduction in IGA from Baseline.
Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area
Change from Baseline in the Worst Itch-Numeric Rating Scale (WI-NRS) score ≥4. Itch severity is graded on an 11-point scale where 0 represents "no itch" and 10 represents "worst itch imaginable".
Assessment of subject satisfaction with treatment based on the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM measures a subject's level of satisfaction or dissatisfaction with the treatment. Composite scores can range from 0 to 100; higher scores indicate better satisfaction.
Any local and systemic AEs (Adverse Events)/serious AEs
Number of subjects with presence of the following LSRs (Local Skin Reactions): edema, excoriations, oozing/vesiculation/crusting, and erosions at any study visit.
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.
Proportion of subjects with 2-point reduction in IGA from Baseline.
Change from Baseline in each individual NS Sign (erythema and scaling). Severity of each NS sign is graded on a 5-point scale.
Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area
Change from Baseline in the Worst Itch-Numeric Rating Scale (WI-NRS) score. Itch severity is graded on an 11-point scale where 0 represents "no itch" and 10 represents "worst itch imaginable".
Assessment of subject satisfaction with treatment based on the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM measures a subject's level of satisfaction or dissatisfaction with the treatment. Composite scores can range from 0 to 100; higher scores indicate better satisfaction.
Proportion of subjects requiring rescue therapy
Any local and systemic AEs (Adverse Events)/serious AEs
Number of subjects with presence of the following LSRs (Local Skin Reactions): edema, excoriations, oozing/vesiculation/crusting, and erosions at any study visit.
| Arm | Type | Description |
|---|---|---|
| QRX003 lotion, 4% BID | EXPERIMENTAL | Subjects will apply test article twice daily (BID) for 12 weeks |
| QRX003, 4% BID | EXPERIMENTAL | Subjects will apply test article twice daily (BID) for 12 weeks |
| QRX003, 4% QAM | EXPERIMENTAL | Subjects will apply test article once daily in the morning (QAM) for 12 weeks |
| QRX003-2% QAM | EXPERIMENTAL | Subjects will apply test article once daily in the morning (QAM) for 12 weeks |
| QRX003-4% QAM | EXPERIMENTAL | Subjects will apply test article once daily in the morning (QAM) for 12 weeks |
| Vehicle Lotion | EXPERIMENTAL | Subjects will apply test article once daily in the morning (QAM) for 12 weeks |
| QRX003-4% BID | EXPERIMENTAL | Subjects will apply test article twice daily BID for 12 weeks |
| Name | Type | Description |
|---|---|---|
| QRX003 | DRUG | Serine Protease Inhibitor |
| QRX003, 4% Lotion | DRUG | QRX003 Topical Lotion containing 4% active drug (serine protease inhibitor) |
| QRX003-2% Lotion | DRUG | QRX003Topical Lotion containing 2% active drug (serine protease inhibitor) |
| QRX003-4% Lotion QAM | DRUG | QRX003Topical Lotion containing 4% active drug (serine protease inhibitor) |
| Vehicle | DRUG | Vehicle Lotion |
| QRX003-4% Lotion BID | DRUG | QRX003Topical Lotion containing 4% active drug (serine protease inhibitor) |
Inclusion Criteria: 1. Participant is male or female and at least 4 years of age. 2. Participant has provided written informed consent/assent. Based on the participant's age and local regulations , a participant under legal age of consent must provide written informed assent and be accompanied by t...
QRX003 is an investigational small molecule therapy being developed for the treatment of Netherton Syndrome, a rare genetic skin disorder. It is formulated as a topical lotion and is currently in Phase 2 clinical development. QRX003 has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA.
QRX003 is being developed by Quoin Pharmaceuticals, Ltd., which trades under the ticker QNRX. The company is advancing the candidate as a topical lotion for Netherton Syndrome across multiple Phase 2 clinical studies.
QRX003 is in Phase 2 clinical development for Netherton Syndrome. It is investigational and has not been approved by the FDA. Four trials are registered, all currently active, with a combined planned enrollment of 74 participants across the United States and the United Kingdom.
QRX003 is being evaluated in four registered clinical trials: NCT07538583, a Phase 2/3 study in the US and UK; NCT06953466 in the US; NCT05789056, an open-label safety and efficacy study; and NCT05521438, a safety, tolerability, and efficacy study. All are in Netherton Syndrome patients.
Yes. QRX003-2% Lotion, QRX003-2%, QRX003-4% Lotion QAM, QRX003-4% QAM, QRX003-4% Lotion BID, QRX003-4%, and QRX003 4% Lotion are all alternative names for QRX003. These refer to different concentration and dosing formulations of the same investigational lotion developed by Quoin Pharmaceuticals.
QRX003 has received three FDA designations for Netherton Syndrome: Orphan Drug, Fast Track, and Rare Pediatric Disease. These designations are intended to support and expedite development of therapies for serious rare conditions. QRX003 remains investigational and is in Phase 2 clinical development.