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AN2728

Phase 1

Plaque-type Psoriasis | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Mar 5, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

AN2728 · 1 trial · 1 indication

Phase 1 1
NCT01258088Safety Study of Ointment for the Treatment of Plaque-type PsoriasisPlaque-type Psoriasis
COMPLETED16 Analytics
PHASE1COMPLETED
Safety Study of Ointment for the Treatment of Plaque-type Psoriasis
Plaque-type PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
Up to 21 days

12-lead ECG, clinical laboratory tests, urinalysis, spontaneous/elicited adverse event (AE) reporting, local site reactions, physical exam and vital signs (blood pressure, heart rate).

Secondary Endpoints

Pharmacokinetic profile
16 Days Maximum
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: AN2728 OintmentACTIVE_COMPARATOR -
Cohort 1: AN2728 VehiclePLACEBO_COMPARATOR -
Cohort 3: AN2728 OintmentACTIVE_COMPARATOR -
Cohort 3: AN2728 VehiclePLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AN2728 OintmentDRUG5mg/cm2, BID
AN2728 VehicleDRUG5mg/cm2 BID
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * White males, 18 - 55 years (inclusive) of age at the time of randomization. * Body weight between 60-90 kg (Body Mass Index \[BMI\] between 19 and 30 kg/m2 \[inclusive\]). * Willing and able to comply with study instructions and commit to all follow-up visits. * Have adequate ...

Countries:Australia
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Frequently asked questions about AN2728

What is AN2728 used for?

AN2728 is an investigational small molecule being developed for dermatology conditions, specifically plaque-type psoriasis and atopic dermatitis. Clinical trials have evaluated it as a topical ointment for mild-to-moderate atopic dermatitis in adults and adolescents, and for plaque-type psoriasis. It is not FDA approved and remains in clinical development.

Who makes AN2728?

AN2728 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company has sponsored clinical trials of the drug across multiple countries, including the United States and Australia.

What phase is AN2728 in?

AN2728 is in Phase 1 and Phase 2 clinical development. Completed trials include Phase 1 safety studies and Phase 2 efficacy studies for atopic dermatitis and plaque-type psoriasis. The drug is investigational and has not received FDA approval.

What clinical trials is AN2728 in?

AN2728 has been studied in several completed trials, including NCT01258088 for plaque-type psoriasis, NCT01301508 for atopic dermatitis, NCT01602341 for adolescents with atopic dermatitis, and NCT01652885 for safety and pharmacokinetics in adolescents. All six trials are completed with no active trials ongoing.

Is AN2728 the same as AN2898?

AN2728 is not the same as AN2898, but they have been studied together. A Phase 2 trial, NCT01301508, evaluated the efficacy and safety of both AN2898 and AN2728 topical ointments for treating mild-to-moderate atopic dermatitis.