A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Официальное название

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

Обзор

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).

Вмешательства

• Препарат PF-07275315
  subcutaneous injection
• Препарат PF-07264660
  subcutaneous injection
• Другое Placebo
  subcutaneous injection

Первичные конечные точки

• The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. [Срок оценки: Week 16]

Вторичные конечные точки (7)

• 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Screening through study completion, an average of 36 weeks.]
• The number and % of participants with treatment emergent AEs [Срок оценки: Screening - Week 36]
• The number and % of participants with clinically significant changes in vital signs [Срок оценки: Screening - Week 36]
• The number and % of participants with clinically significant changes in ECG [Срок оценки: Screening - Week 36]
• The number and % of participants with clinically significant changes in laboratory tests [Срок оценки: Screening - Week 36]

Критерии участия

Критерии включения

Must meet the following AD criteria:

• Participants aged 18 years or older
• 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.

Other Inclusion Criteria:

• BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).
• Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Критерии исключения

\- Medical Conditions:

• 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.
• Any of the following acute or chronic infections or infection history:

• Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
• Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
• Active chronic or acute skin infection requiring treatment with systemic \[(not IV)\] antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections (requiring no more than topical anti-infective treatments) within 1 week prior to Day 1.
• Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
• 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.

\- Prior/Concomitant Therapy:

• Current use of any prohibited concomitant medication(s).
• Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks prior to Day 1.

\- Prior/Concurrent Clinical Study Experience:

• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
• HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
• Evidence of active or latent TB, or inadequately treated infection with Mycobacterium TB. A participant who is currently being treated for active or latent TB infection must be excluded from this study.

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 · 52 центра

• Allervie Clinical Research — Birmingham
• Onyx Clinical Research - Peoria — Peoria
• Medical Dermatology Specialists — Phoenix
• Onyx Clinical Research — Phoenix
• Banner - University Medicine Dermatology Clinic — Tucson
• Marvel Clinical Research — Huntington Beach
• California Allergy and Asthma Medical Group — Los Angeles
• University Dermatology Trials, INC. — Newport Beach
• … и ещё 44 центра

Китай · 19 центров

• Beijing Friendship Hospital Affiliate of Capital University — Пекин
• The First Affiliated Hospital Of Fujian Medical University — Фучжоу
• Dongguan People's Hospital — Дунгуань
• Guangdong Province Dermatology Hospital — Гуанчжоу
• The First Hospital of Hebei Medical University — Shijiazhuang
• The Second Xiangya Hospital of Central South University — Чанша
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань
• Affiliated Hospital of Jiangsu University — Zhenjiang
• … и ещё 11 центров

Канада · 8 центров

• Wiseman Dermatology Research Inc. — Winnipeg
• Medicor Research Inc — Greater Sudbury
• Sudbury Skin Clinique — Greater Sudbury
• Lima's Excellence in Allergy and Dermatology Research — Hamilton
• DermEdge Research — Mississauga
• Toronto Research Centre — Toronto
• INTERMED Groupe Sante — Chicoutimi
• Centre de Recherche Saint-Louis inc. — Québec

Япония · 6 центров

Список центров уточняется — проверьте первичный протокол.

Польша · 6 центров

Список центров уточняется — проверьте первичный протокол.

Австралия · 4 центра

• Australian Clinical Research Network — Sydney
• Box Hill Hospital — Box Hill
• Sinclair Dermatology — East Melbourne
• Fremantle Dermatology — Fremantle

Германия · 3 центра

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05995964 · C4531002 · 2023-505218-68-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗