Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis (EMPORIA)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Plaque Psoriasis

Treatments: Drug: PF-07038124 ointment; Drug: Vehicle ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04664153

C3941002

2020-003977-23 (EudraCT Number)

Details and patient eligibility

About

This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.

Enrollment: 104 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
• Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.

Exclusion criteria

• Presence of skin comorbidities that would interfere with study assessment or response to treatment.
• Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups, including a placebo group

atopic dermatitis - PF-07038124 ointment

Experimental group

Treatment:

Drug: PF-07038124 ointment

atopic dermatitis - vehicle ointment

Placebo Comparator group

Treatment:

Drug: Vehicle ointment

plaque psoriasis - PF-07038124 ointment

Experimental group

Treatment:

Drug: PF-07038124 ointment

plaque psoriasis - vehicle ointment

Experimental group

Treatment:

Drug: Vehicle ointment