Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Summary

B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country.

The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to \<18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.

Conditions

• Dermatitis, Atopic

Interventions

DRUG

Abrocitinib 100 mg

In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.

DRUG

Abrocitinib 200 mg

In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.

DRUG

Placebo

For subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.

DRUG

Abrocitinib 100 mg

For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.

DRUG

Abrocitinib 100 mg

In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.

DRUG

Abrocitinib 200 mg

In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-08

Primary Completion

2025-12-22

Completion

2025-12-22

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Bulgaria
• Canada
• Chile
• China
• Czechia
• Finland
• Germany
• Hungary
• Israel
• Italy
• Japan
• Latvia
• Mexico
• Netherlands
• Poland
• Romania
• Russia
• Serbia
• Slovakia
• South Korea
• Spain
• Taiwan
• United Kingdom

Study Locations