NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

CompletedPhase 2

Sponsor: Pfizer

Conditions: Atopic Dermatitis

Interventions: PF-04965842 200 mg, PF-04965842 100 mg, Placebo

Countries: United States, Canada

B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Clinical diagnosis of chronic moderate-to-severe atopic dermatitis (AD) for at least 1 year
* Recent history of inadequate response to medicated topical therapy for AD or required systemic therapy to control disease
* Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at least 16, Peak Pruritus NRS at least 4

Exclusion Criteria:

* A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction
* Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment
* Participants who have received prior treatment with any systemic JAK inhibitors
* Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within specified time frames prior to the first dose of study medication, including topical treatments that could affect AD
* Pregnant or breastfeeding women or sexually-active women of childbearing potential who are unwilling to use contraception

Locations (11)

Encinitas, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Largo, Florida, United States
Tampa, Florida, United States
Plainfield, Indiana, United States
Dearborn, Michigan, United States
New York, New York, United States
Dallas, Texas, United States
Calgary, Alberta, Canada
Montreal, Quebec, Canada