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GW842470X

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |GSK plc|Last Updated: Sep 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Clinical trial landscape

GW842470X · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00354510Topical GW842470X In Adults Patients With Moderate Atopic DermatitisAtopic Dermatitis
COMPLETED190 Analytics
PHASE2COMPLETED
Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI).
Number of subjects with abnormal physical examination findings
Up to Day 22
Number of subjects with abnormal blood pressure
Up to Day 22
Number of subjects with abnormal heart rate
Up to Day 22
Number of subjects with abnormal 12-lead ECG assessment
Up to Day 22
Number of subjects with abnormal findings on lead II cardiac monitoring
Up to Day 10
Number of subjects with abnormal clinical laboratory tests
Up to Day 22
AUC
Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Cmax
Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10

Secondary Endpoints

Safety and tolerability of 3% GW842470X cream
Clinical efficacy using SCORing Atopic Dermatitis score & Investigators Global Assessment Scale
Symptoms: pruritus & sleep loss
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single dose 1 cohortEXPERIMENTALSubjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1.
Repeat dose 1 cohortEXPERIMENTALSubjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1
Repeat dose 2 cohortEXPERIMENTALSubjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1
Repeat dose 3 cohortEXPERIMENTALSubjects with BSA disease involvement \>=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1

Interventions

NameTypeDescription
GW842470X creamDRUG -
GW842470XDRUGGW842470X will be available as a yellow smooth water-in-oil cream.
PlaceboDRUGGW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion criteria: * Moderate atopic dermatitis patients (IGA=3). * The disease involvement must be \>5% of body surface area. * Female patients of child-bearing potential must use an appropriate method of contraception. Exclusion criteria: * Patients with any active skin disease other than atop...

Countries:GermanyNetherlands
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Frequently asked questions about GW842470X

What is GW842470X used for?

GW842470X is an investigational small molecule being developed for the treatment of atopic dermatitis, also known as eczema. It is a topical cream intended for use in adult patients with moderate atopic dermatitis. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes GW842470X?

GW842470X is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of this topical treatment for atopic dermatitis.

What phase is GW842470X in?

GW842470X is in Phase 2 clinical development. A Phase 2 trial has been completed, along with a Phase 1 study. The drug is investigational and has not received regulatory approval. It is being studied as a topical treatment for moderate atopic dermatitis in adults.

What clinical trials is GW842470X in?

GW842470X has been studied in two completed clinical trials. NCT00354510 was a Phase 2 study of topical GW842470X in adults with moderate atopic dermatitis, enrolling 190 participants in Germany and the Netherlands. NCT00356642 was a Phase 1 study of single and ten-day repeat applications of GW842470X cream in patients with atopic dermatitis.

Is GW842470X FDA approved?

GW842470X is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials for atopic dermatitis. The drug remains in clinical development and has not been authorized for marketing or use outside of clinical research settings.