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GW842470X

Phase 2

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

GW842470X development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2006

GW842470X target and mechanism

ModalitySmall molecule

Also known as GW842470X cream

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment235

FDA Designations

No designations recorded

GW842470X clinical trials

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?

GW842470X is an investigational small molecule drug developed by GSK plc for atopic dermatitis, a form of eczema. It is formulated as a topical cream and was studied in clinical trials in adult patients with moderate atopic dermatitis. It is not approved and remains in clinical development.

What is GW842470X used for in atopic dermatitis?

GW842470X is being studied for the treatment of atopic dermatitis, also called atopic eczema. The clinical program focused on adults with moderate atopic dermatitis, evaluating topical application of the cream. It is an investigational therapy and has not been approved for any indication.

Who makes GW842470X?

GW842470X is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials of the topical cream in patients with atopic dermatitis.

What phase is GW842470X in?

GW842470X has completed Phase 2 clinical development for atopic dermatitis. Two trials have been completed, one Phase 1 study and one Phase 2 study, and no trials are currently active. The drug is investigational and has not been approved by the FDA.

What clinical trials is GW842470X in?

GW842470X has been evaluated in two completed trials. NCT00356642 was a Phase 1 study of single and ten day repeat topical applications in 45 patients with atopic dermatitis in Germany. NCT00354510 was a Phase 2 trial of topical GW842470X in 190 adults with moderate atopic dermatitis in Germany and the Netherlands.

Is GW842470X the same as GW842470X cream?

Yes, GW842470X cream is the same asset as GW842470X. The cream refers to the topical formulation used in the clinical trials, which applied the drug directly to the skin of patients with atopic dermatitis. Both names refer to the GSK investigational compound.