A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

Официальное название

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Обзор

This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.

Вмешательства

• Препарат ENV-294
  ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
• Другое Placebo
  Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Первичные конечные точки

• Percent change in Eczema Area and Severity Index (EASI) score [Срок оценки: Baseline to Week 12]

Вторичные конечные точки (6)

• Incidence of Treatment Emergent Adverse Events [Срок оценки: Baseline to Week 12 and Week 16]
• EASI-75 Response [Срок оценки: Baseline to Week 12]
• vIGA Response [Срок оценки: Baseline to Week 12]
• Percent change in Scoring Atopic Dermatitis (SCORAD) [Срок оценки: Baseline to Week 12]
• Patient-Reported Outcomes [Срок оценки: Baseline to Week 12]
• Patient-Reported Outcomes [Срок оценки: Baseline to Week 12]

Критерии участия

Критерии включения

In order to participate in this study all participants must:

• Be at least 18 years of age at the time of signing the ICF.
• Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
• Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and/or inadequate response to a systemic therapy within 12 months before Screening.
• Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:

• A vIGA score of 3 (moderate) or 4 (severe)
• EASI score of ≥16
• Body surface area involvement of ≥10%
• Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
• Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.
• Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.

Критерии исключения

Participants are excluded if they:

• Have any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
• Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
• Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response as determined by the investigator.
• Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined by the investigator.
• Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug.
• Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.

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 · 9 центров

• Enveda Investigative Site — Encinitas
• Enveda Investigative Site — Los Angeles
• Enveda Investigative Site — Northridge
• Enveda Investigative Site — Boca Raton
• Enveda Investigative Site — Indianapolis
• Enveda Investigative Site — Plainfield
• Enveda Investigative Site — Dallas
• Enveda Investigative Site — San Antonio
• … и ещё 1 центр

Идентификаторы

NCT: NCT07643766 · ENV-294-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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