Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Pfizer

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic; Dermatitis; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Immune System Diseases; Skin Diseases; Hypersensitivity; Eczema; Skin Diseases, Eczematous; Skin Diseases, Genetic

Treatments: Drug: PF-04965842 200 mg; Drug: PF-04965842 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03627767

REGIMEN

JADE REGIMEN (Other Identifier)

B7451014

2018-000501-23 (EudraCT Number)

Details and patient eligibility

About

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

Full description

Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.

Enrollment: 1,235 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12 years of age or older with a minimum body weight of 40 kg
• Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)
• Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion criteria

• Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
• Prior treatment with JAK inhibitors
• Other active nonAD inflammatory skin diseases or conditions affecting skin
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
• Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,235 participants in 3 patient groups, including a placebo group

PF-04965842 100 mg QD

Experimental group

Description:

Double-blind randomized treatment following open label run-in period.

Treatment:

Drug: PF-04965842 100 mg

PF-04965842 200 mg QD

Experimental group

Description:

Double-blind randomized treatment following open label run-in period.

Treatment:

Drug: PF-04965842 200 mg

Placebo QD

Placebo Comparator group

Description:

Double-blind randomized treatment following open label run-in period.

Treatment:

Drug: Placebo