Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle (Placebo); Drug: PF-06700841

Study type: Interventional

Funder types: Industry

Identifiers

NCT03903822

B7931022

2018-003050-24 (EudraCT Number)

Details and patient eligibility

About

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

Enrollment: 292 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Atopic Dermatitis for at least 3 months
• Investigator's Global Assessment (IGA) Score of 2 or 3
• Eczema Area Severity Index (EASI) score of 3-21
• Body Surface Area (BSA) of 2-20%
• Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion criteria

• Other forms of dermatological diseases (other than atopic dermatitis)
• Fitzpatrick skin type score greater than 5
• Clinically significant abnormal ECG, vital signs, and laboratory values
• Infection with HBV, HCV, herpes zoster or tuberculosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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292 participants in 8 patient groups, including a placebo group

PF-06700841 0.1% cream QD

Experimental group

Description:

PF-06700841 0.1% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 0.3% cream QD

Experimental group

Description:

PF-06700841 0.3% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 1% cream QD

Experimental group

Description:

PF-06700841 1% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 3% cream QD

Experimental group

Description:

PF-06700841 3% cream applied once daily (QD)

Treatment:

Drug: PF-06700841

PF-06700841 0.3% cream BID

Experimental group

Description:

PF-06700841 0.3% cream applied twice daily (BID)

Treatment:

Drug: PF-06700841

PF-06700841 1% cream BID

Experimental group

Description:

PF-06700841 1% cream applied twice daily (BID)

Treatment:

Drug: PF-06700841

Vehicle cream QD

Placebo Comparator group

Description:

Vehicle cream applied once daily (QD)

Treatment:

Drug: Vehicle (Placebo)

Vehicle cream BID

Placebo Comparator group

Description:

Vehicle cream applied twice daily (BID)

Treatment:

Drug: Vehicle (Placebo)