A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema

Официальное название

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Обзор

The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin. The study is seeking participants who: 1. Are 18 to 64 years of age; 2. Were confirmed to have AD at least 6 months ago; 3. Do not have a suitable prescribed medicine for AD; 4. Are considered by their doctors to have moderate to severe AD. The study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.

Вмешательства

• Препарат PF-08049820
  Tablet
• Препарат Placebo
  Tablet

Первичные конечные точки

• Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12 [Срок оценки: Week 12]

Вторичные конечные точки (6)

• Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points [Срок оценки: Day 1 through Week 16]
• Percent change from baseline in EASI total score at scheduled time points other than Week 12 [Срок оценки: Day 1 through Week 16]
• Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >2 points at scheduled time points [Срок оценки: Day 1 through Week 16]
• Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus-Numerical Rating Scale (PP-NRS4) at scheduled time points [Срок оценки: Day 1 through Week 16]
• Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs and ECGs [Срок оценки: Day 1 through Week 16]
• Change from baseline in biomarker at scheduled time points [Срок оценки: Day 1 through Week 16]

Критерии участия

Критерии включения

Participants must meet the following criteria:

• Are 18 to 64 years of age
• Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
• Have moderate to severe AD as defined by the following at screening and baseline visits:

• Affected body surface area (BSA) greater than or equal to 10% and up to 60%;
• Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;
• Eczema Area and Severity Index (EASI) greater than or equal to 16;

AND

-Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit

• Do not have a suitable prescribed medicine for AD.
• Body Mass Index (BMI) of 18 to 38 kg/m2 and a total body weight greater than 48 kg (106 lbs)

Критерии исключения

Participants must not meet the following criteria:

• Have an infection that requires treatment
• Have other skin conditions other than AD
• Have severe uncontrolled asthma
• Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 12 центров

• Marvel Clinical Research — Huntington Beach
• Metropolis Dermatology - DTLA — Los Angeles
• Northridge Clinical Trials — Northridge
• Clinical Science Institute — Santa Monica
• Gsi Clinical Research — Margate
• Skin Research of South Florida — Miami
• Montefiore - Jacobi Dermatology Clinic — The Bronx
• Montefiore - Clinical Research Center — The Bronx
• … и ещё 4 центра

Япония · 6 центров

• Hattori Dermatology Clinic — Takasaki
• Kosugi Dermatology Clinic — Kawasaki-shi
• Queen's square Medical Facilities Queen's square Dermatology and Allergology — Yokohama
• Dermatology and Ophthalmology Kume Clinic — Sakai
• Nihonbashi Sakura Clinic — Chuo-ku
• Fukuwa Clinic — Chuo-ku

Канада · 1 центр

• Centre de Recherche Saint-Louis inc. — Québec

Китай · 1 центр

• Huashan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT07216027 · C6231002 · 2025-522965-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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