Open Label, Safety and Efficacy Study of QRX003 Lotion in... | NCT05789056

NCT05789056

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

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

Name	Type	Description	Arm Group Labels	Other Names
QRX003, 4% Lotion	Drug	QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)	QRX003, 4% BID QRX003, 4% QAM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects with 1-point reduction on 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
Proportion of subjects with 2-point reduction on IGA	Proportion of subjects with 2-point reduction in IGA from Baseline.	Up to week 16
NS surface area change	Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area	Up to week 16
WI-NRS score change	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".	Up to week 16
Assessment of subject satisfaction with treatment based on 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
Proportion of subjects requiring rescue therapy	Proportion of subjects requiring rescue therapy	Up to week 16

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.
Subject is on a stable treatment regimen including systemic therapy for NS prior to baseline that is expected to remain stable for the duration of the study

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 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 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.

Name	Role	Phone	Extension	Email
TI Clinical Research	Contact	858-571-1800	147	clinicalresearch@therapeuticsinc.com
Oleg G Khatsenko	Contact	858-571-1800	166	okhatsenko@therapeuticsinc.com

ID	Term
D000015	Abnormalities, Multiple
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D016113	Ichthyosiform Erythroderma, Congenital