Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as QRX003, 4% Lotion, QRX003
QRX003, 4% · 3 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.
| 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 |
| Name | Type | Description |
|---|---|---|
| QRX003 | DRUG | Serine Protease Inhibitor |
| QRX003, 4% Lotion | DRUG | QRX003 Topical 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 lotion being studied for the treatment of Netherton Syndrome, a rare genetic skin disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA.
QRX003 is a small molecule lotion developed for Netherton Syndrome. Its specific molecular target has not been disclosed in available clinical trial information, so its precise mechanism of action is not publicly detailed.
QRX003 is being developed by Quoin Pharmaceuticals, Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol QNRX. The company is conducting clinical trials of QRX003 in the United States.
QRX003 is currently in Phase 2 clinical development for Netherton Syndrome. It has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA, but it remains investigational and is not yet approved.
QRX003 is being evaluated in three recruiting Phase 2 trials in the United States: NCT05789056 (20 participants, ages 14 and older), NCT06953466 (8 participants, ages 14 and older), and NCT07538583 (16 participants, ages 4 and older). All three are open-label, controlled studies in Netherton Syndrome.
Yes, QRX003 is also known as QRX003, 4% Lotion. The 4% formulation is the strength being tested in clinical trials for Netherton Syndrome.