Phase
Condition
Dermatitis, Atopic
Allergy
Skin Infections/disorders
Treatment
Placebo
PF-07832837
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at thetime of signing the ICD
Part 2 only: Adult participants, who at the time of screening, are between the agesof 18 and 70 years, inclusive. Participants above 65 years need to be discussed withthe sponsor.
Part 1 only: Participants who are overtly healthy as determined by medicalevaluation including medical history, physical examination, vital sign assessments,temperature, 12-lead ECGs, laboratory tests
BMI of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs)
Part 2 only: Must meet the following AD criteria:
Have a clinical diagnosis of chronic AD (also known as atopic eczema) forapproximately 1 year prior to Day 1 and have the diagnosis of AD confirmed.
Either have had an inadequate response to treatment with topical medications (for at least 4 consecutive weeks within 1 year of the first dose of the studyintervention). OR Have a documented reason why topical treatments areconsidered medically inappropriate within the last year.
Have moderate to severe AD (defined as having an affected BSA (captured as partof EASI) ≥10%, IGA ≥3, and EASI ≥12 at both the screening and baseline visits).
Have an otherwise healthy medical evaluation (other than signs and symptoms ofAD) including medical history, physical examination, vital sign assessments,temperature, 12-lead ECGs, laboratory tests.
Mild or moderate asthma that is well-controlled (not requiring high dose inhaled corticosteroids, systemic [oral or parenteral] corticosteroids, or biologic asthma treatments).
Exclusion
Exclusion Criteria:
Have a history of systemic infection requiring hospitalization and parenteralantimicrobial therapy, any lymphoproliferative disorder, malignancies.
Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,immunological/rheumatological disorder.
Have undergone significant trauma or major surgery within 1 month of the first doseof study intervention.
Evidence of active, latent, or inadequately treated infection with Mycobacteriumtuberculosis (TB) as defined by both of the following:
A positive QuantiFERON-TB Gold In-tube or equivalent test.
History of either untreated or inadequately treated latent or active TBinfection, or current treatment for the same.
Part 2 Only
Currently have active forms of other inflammatory skin diseases
Have history of or current evidence of skin conditions at the time of Day 1 thatwould interfere with evaluation of atopic dermatitis or response to treatment. Haveactive chronic or acute skin infection requiring treatment with systemicantibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2weeks prior to Day 1, or superficial skin infections within 1 week prior to Day 1.
Score of >5 on the Fitzpatrick Skin Type Assessment.
History of anaphylaxis with the following exceptions: participants with sensitivityand/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, penicillin,sulfa drugs, nonsteroidal anti-inflammatory drugs [NSAIDs], peanuts) may beenrolled, if in the opinion of the investigator, the participant is aware of thehypersensitivity and avoids the problematic allergen. Participants must carryappropriate treatment for anaphylaxis and must know how to manage anaphylacticreactions.
Any investigational or experimental therapy taken or procedure performed for AD,psoriasis, psoriatic arthritis, rheumatoid arthritis or other inflammatory diseasesin the previous 1 year should be discussed with the Pfizer Medical Monitor (ordesignee).
Study Design
Study Description
Connect with a study center
Anaheim Clinical Trials, LLC
Anaheim, California 92801
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.