Safety, Tolerability and Efficacy of QRX003 Lotion in Sub... | NCT05521438

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QRX003-2% QAM	Experimental	Subjects will apply test article once daily in the morning (QAM) for 12 weeks	Drug: QRX003-2% Lotion
QRX003-4% QAM	Experimental	Subjects will apply test article once daily in the morning (QAM) for 12 weeks	Drug: QRX003-4% Lotion QAM
Vehicle Lotion	Experimental	Subjects will apply test article once daily in the morning (QAM) for 12 weeks	Drug: Vehicle
QRX003-4% BID	Experimental	Subjects will apply test article twice daily BID for 12 weeks	Drug: QRX003-4% Lotion BID

Name	Type	Description	Arm Group Labels	Other Names
QRX003-2% Lotion	Drug	QRX003Topical Lotion containing 2% active drug (serine protease inhibitor)	QRX003-2% QAM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy Endpoints-1-point IGA	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.	Up to week 16
Efficacy Endpoints-2-point IGA	Proportion of subjects with 2-point reduction in IGA from Baseline.	Up to week 16
Efficacy Endpoints-NS Sign	Change from Baseline in each individual NS Sign (erythema and scaling). Severity of each NS sign is graded on a 5-point scale.	Up to week 16
Efficacy Endpoints-BSA	Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area	Up to week 16
Efficacy Endpoints-WI-NRS score	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".	Up to week 16
Efficacy Endpoints-TSQM	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.	Up to week 16
Efficacy Endpoints-Rescue Therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is a male or non-pregnant female at least 14 years of age.
Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutation.
Subject has NS lesions in the Treatment Area (i.e., arms or lower legs).
Subject is in good general health and free of any disease state or physical condition that might impair evaluation of NS or exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has any skin pathology in the Treatment Area or condition that, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
Subject has Fridericia-corrected QT ≥ 450 ms for males or ≥ 470 ms for females
Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled.
Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline.
Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
Subject has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline.
Subject has used systemic prescription treatment for NS within 4 weeks prior to Visit 2/Baseline.
Subject has used systemic biologic therapy for NS.
Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline.
Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline.
Subject is currently enrolled in an investigational drug, biologic, or device study.
Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.

Facility	Status	City	State	ZIP	Country	Contacts
Site #1		San Diego	California	92123	United States
Site #4

ID	Term
D000015	Abnormalities, Multiple
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D016113	Ichthyosiform Erythroderma, Congenital
D007057	Ichthyosis
D012868	Skin Abnormalities
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D007232	Infant, Newborn, Diseases
D007642	Keratosis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases