The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction. This study is seeking participants who: * are 18 years of age or more. * Were confirmed to have AD at least 6 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. In Stage 1 of the study, participants will receive either PF-07275315 or PF-07264660 or placebo. Stage 1 is complete. In Stage 2 of the study participants will receive either PF-07275315 or placebo. In Stage 3 of the study participants who have received anti-inflammatory proteins, will receive either PF-07275315 or placebo. In Stage 4 of the study participants will receive either PF-07264660 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied. PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of each Stage. The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective. Participants in Stages 1, 2 and 4 will be involved in this study for up to 40 weeks (10 months). Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
340
subcutaneous injection
subcutaneous injection
subcutaneous injection
Allervie Clinical Research
Birmingham, Alabama, United States
RECRUITINGOnyx Clinical Research - Peoria
Peoria, Arizona, United States
RECRUITINGMedical Dermatology Specialists
Phoenix, Arizona, United States
RECRUITINGOnyx Clinical Research
Phoenix, Arizona, United States
The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.
EASI75 (≥75% improvement from baseline) at Week 16
Time frame: Week 16
The number and % of participants achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points
vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points
Time frame: Screening through study completion, an average of 36 weeks.
The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
Time frame: All scheduled timepoints other than Week 16, screening through study completion, an average of 36 weeks.
The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points
Percent change from baseline in EASI total score at scheduled time points
Time frame: Screening through study completion, an average of 36 weeks.
The number and % of participants with treatment emergent AEs
Incidence of treatment emergent AEs
Time frame: Screening - Week 36
The number and % of participants with clinically significant changes in vital signs
Incidence of clinically significant changes in vital signs
Time frame: Screening - Week 36
The number and % of participants with clinically significant changes in ECG
Incidence of clinically significant changes in ECG
Time frame: Screening - Week 36
The number and % of participants with clinically significant changes in laboratory tests
Incidence of clinically significant changes in laboratory tests
Time frame: Screening - Week 36
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Banner - University Medicine Dermatology Clinic
Tucson, Arizona, United States
RECRUITINGMarvel Clinical Research
Huntington Beach, California, United States
RECRUITINGCalifornia Allergy and Asthma Medical Group
Los Angeles, California, United States
RECRUITINGUniversity Dermatology Trials, INC.
Newport Beach, California, United States
RECRUITINGNorthridge Clinical Trials
Northridge, California, United States
RECRUITINGProfound Research LLC
Oceanside, California, United States
RECRUITING...and 88 more locations