Atopic Dermatitis Clinical Study (18 yrs+)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of PF-07275315 and PF-07264660 in Adult Participants with Moderate – Severe Atopic Dermatitis

Study Description

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.

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).

Brief Summary

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.

Condition or Disease

Atopic Dermatitis

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	340
Primary Outcome Measures	1. The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.
Actual Study Start Date:	August 2023
Estimated Primary Completion Date:	September 2026

Eligibility Criteria

Ages Eligible for Study:	18 & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Atopic Dermatitis

Inclusion Criteria

Clinical diagnosis of chronic atopic dermatitis: for at least 6 months prior to Day 1 with diagnosis confirmed by photograph; either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutive weeks within 6 to 12 months of the first dose of the study intervention; OR documented reason why topical treatments are considered medically inappropriate; moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits); bio-experienced cohort-partial or non-responder to anti-inflammatory proteins (also known as biologics), intolerance or AEs to anti-inflammatory proteins or loss of access to anti-inflammatory proteins with ≥12 weeks of treatment within 5 years
BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs)

Exclusion Criteria

Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate including but not limited to: SLE or other complement disorders; Type 1 diabetes; IBD; Multiple Sclerosis
History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or to the excipients of the formulated drug products. Participants with significant reactions to single, identified, avoidable allergens (eg, peanut allergy) may be eligible if avoidance of these allergens during the study is feasible
History of or current evidence of inflammatory skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that could interfere with evaluation of AD or response to treatment
Any 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

ADDITIONAL DETAILS

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Severe Atopic Dermatitis Study (18 Years+)