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PDI-192

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Precision BioSciences, Inc.|Last Updated: May 29, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment151

FDA Designations

No designations recorded

Clinical trial landscape

PDI-192 · 1 trial · 1 indication

Phase 2 1
NCT01826461An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic DermatitisAtopic Dermatitis
COMPLETED151 Analytics
PHASE2COMPLETED
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

"Treatment Success" based on change in Investigator's Global Assessment (IGA)
Baseline and Day 29

Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.

Secondary Endpoints

Change in Pruritis Severity at Day 29
Baseline and Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PDI-192 Foam, 0.1%EXPERIMENTALtopical foam, 0.1% concentration, twice daily
PDI-192 Foam, 0.15%EXPERIMENTALtopical foam, 0.15% concentration, twice daily
Vehicle FoamPLACEBO_COMPARATORtopical foam, 0% concentration, twice daily

Interventions

NameTypeDescription
PDI-192DRUG -
VehicleDRUG -
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Eligibility Criteria

Age Range3 Months to 17 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis. * Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to stu...

Countries:United States
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Frequently asked questions about PDI-192

What is PDI-192 used for?

PDI-192 is an investigational small molecule being developed for the treatment of atopic dermatitis, a form of eczema. It is intended for use in patients with mild to moderate atopic dermatitis, as evaluated in a clinical trial that included participants as young as 3 months old.

Who makes PDI-192?

PDI-192 is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting clinical research on this investigational drug for atopic dermatitis.

What phase is PDI-192 in?

PDI-192 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating atopic dermatitis.

What clinical trials is PDI-192 in?

PDI-192 has been studied in one completed Phase 2 clinical trial, identified as NCT01826461. This randomized, double-blind, placebo-controlled trial evaluated PDI-192 0.1% and 0.15% in the treatment of mild to moderate atopic dermatitis, enrolling 151 participants in the United States.

Is PDI-192 the same as any other drug?

No alternative names for PDI-192 have been reported. It is identified solely by its code name PDI-192 in clinical trial records, and no other drug names or aliases are associated with this investigational compound.