Evaluating PF-07832837 for safety and tolerability in healthy adults and patients with atopic dermatitis
Official title: A PHASE 1, FIRST IN HUMAN, RANDOMIZED, DOUBLE-BLIND, SPONSOROPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07832837 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Run by Pfizer · NCT06564389 · Data updated 2026-11-12
This study is testing a new drug called PF-07832837 to see if it's safe and tolerable for both healthy adults and adults with moderate to severe atopic dermatitis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 119 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 8 sites (Anaheim, California and 7 other locations) |
| Status | Recruiting |
| Started | November 5, 2024 |
| Main results expected | June 2, 2027 |
| Study ends | June 2, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06564389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 70 with moderate to severe atopic dermatitis or healthy adults aged 18 to 55.
✕Probably not a fit
Patients with mild atopic dermatitis or those who do not meet the eligibility criteria will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the safety, tolerability, and pharmacokinetics of PF-07832837, a monoclonal antibody, in two parts. The first part involves healthy adult participants, while the second part focuses on adults with moderate to severe atopic dermatitis. Participants will receive either the active drug or a placebo in a randomized, double-blind manner. The study will also evaluate the pharmacodynamics of the drug, particularly its effects on clinical signs and symptoms of atopic dermatitis.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from moderate to severe atopic dermatitis.
How similar studies have gone: Other studies involving monoclonal antibodies for atopic dermatitis have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at the time of signing the ICD * Part 2 only: Adult participants, who at the time of screening, are between the ages of 18 and 70 years, inclusive. * Part 1 only: Participants who are overtly healthy as determined by medical evaluation 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: 1. Have a clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and have the diagnosis of AD confirmed by photographs (at screening) and diagnostic criteria for AD. 2. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) consistent with AD treatment guidelines (for at least 4 consecutive weeks within 6 to 12 months (depending on time since initial diagnosis) of the first dose of the study intervention. OR Have a documented reason why topical treatments are considered medically inappropriate within the last year. 3. Have moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, IGA ≥3, and EASI ≥12 at both the screening and baseline visits). 4. Have an otherwise healthy medical evaluation (other than signs and symptoms of AD) including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests. Controlled comorbid diseases are acceptable so long as they do not require administration of prohibited medications. This includes participants with mild or moderate asthma that is well-controlled (not requiring high dose inhaled corticosteroids, systemic \[oral or parenteral\] corticosteroids, or biologic asthma treatments). Exclusion Criteria: * Have a history of systemic infection requiring hospitalization and parenteral antimicrobial 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 dose of study intervention. * Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following: 1. A positive QuantiFERON-TB Gold In-tube or equivalent test. 2. History of either untreated or inadequately treated latent or active TB infection, 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 that would interfere with evaluation of atopic dermatitis or response to treatment. Have active chronic or acute skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks 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 sensitivity and/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, penicillin, sulfa drugs, nonsteroidal anti-inflammatory drugs \[NSAIDs\], peanuts) may be enrolled, if in the opinion of the investigator, the participant is aware of the hypersensitivity and avoids the problematic allergen. Participants must carry appropriate treatment for anaphylaxis and must know how to manage anaphylactic reactions. * Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis, rheumatoid arthritis or other inflammatory diseases in the previous 1 year should be discussed with the Pfizer Medical Monitor (or designee).
Where it's running
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Anaheim Clinical Trials, LLC
Anaheim, California, United States Recruiting -
TCR Medical Corporation
San Diego, California, United States Recruiting -
Miami Dermatology and Laser Research
Miami, Florida, United States Recruiting -
Revival Research Institute, LLC
Troy, Michigan, United States Recruiting -
Paddington Testing Company
Philadelphia, Pennsylvania, United States Recruiting -
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland Not yet recruiting
Show 2 more locations
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Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
Szczecin, West Pomeranian Voivodeship, Poland Not yet recruiting -
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland Not yet recruiting
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.