Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

Официальное название

A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

Обзор

This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

Подробное описание

This study is being conducted to evaluate the efficacy, safety and tolerability of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

Approximately 20 subjects with discoid lupus erythematosus will apply ruxolitinib 1.5% cream, twice daily on active lesions identified at Day 1 and any new lesions that appear, for 24 weeks.

Вмешательства

• Препарат Ruxolitinib 1.5% cream
  Topical application of Ruxolitinib 1.5% cream
• Процедура Application without occlusion in Area 1
  Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.
• Процедура Application under occlusion at night in Area 2
  Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.
• Процедура Application under occlusion at night in Area 1
  Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.
• Процедура Application without occlusion in Area 2
  Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.

Первичные конечные точки

• Change from baseline in target lesion CLASI-A score [Срок оценки: Week 24]

Вторичные конечные точки (4)

• Change from baseline in target lesion CLASI-A score [Срок оценки: Week 12, Week 24]
• Proportion of subjects with an erythema score of 0 (absent) [Срок оценки: Week 24]
• Change from baseline in target lesion SADDLE-A [Срок оценки: Week 12, Week 24]
• Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear) [Срок оценки: Week 24]

Критерии участия

Критерии включения

• Male or female subject 18 years of age or older at the time of consent.
• Confirmed DLE diagnosis.
• Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1.
• Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1.
• Subject has no known history of latent or active tuberculosis (TB) infection.
• Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Критерии исключения

• Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
• Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening.
• Subject is known to have immune deficiency or is immunocompromised.
• Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots.
• Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]).
• Subject is known to have hepatitis B or hepatitis C viral infection.
• Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices.
• Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab.
• Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
• Subject has a known or suspected allergy to ruxolitinib.
• Subject has used ruxolitinib cream (OpzeluraTM).
• Subject has used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1.
• Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• INNO-6051 Site 03 — Fredericton
• Innovaderm Research Inc. — Montreal

Идентификаторы

NCT: NCT06261021 · INNO-6051

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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