A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)

Официальное название

A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata

Обзор

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study drug will be administered intravenously (IV) (into a vein in the arm). The study will last approximately 48 weeks, including screening.

Вмешательства

• Препарат LY4005130
  Administered IV
• Препарат Placebo
  Administered IV

Первичные конечные точки

• Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20 [Срок оценки: Week 24]

Вторичные конечные точки (3)

• Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50) [Срок оценки: Week 24]
• Pharmacokinetics (PK): Trough Concentrations of LY4005130 [Срок оценки: Baseline Through Week 20]
• Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy [Срок оценки: Baseline, Week 24]

Критерии участия

Критерии включения

• Have severe Alopecia Areata (AA) that meets all of the following criteria:

• Hair loss encompassing ≥50% and ≤90% of the scalp, as measured by Severity of Alopecia Tool (SALT) score
• The duration of the current episode of severe AA is at least 6 months and does not exceed 4 years
• No significant spontaneous hair regrowth in the investigator's opinion for at least 6 months
• Agree not to use any AA treatments during the study

Критерии исключения

• Primarily "diffuse" type of AA (characterized by diffuse hair shedding)
• Are currently experiencing other forms of alopecia
• Participants who, in the opinion of the investigator, are currently experiencing or have a history of unstable concomitant disease that requires frequent hospitalizations, and/or frequent use of systemic immunosuppressants that may interfere with participation in the study
• Have received oral JAK Inhibitors in the past
• Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study
• Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 9 центров

• Center For Dermatology Clinical Research, Inc. — Fremont
• Northridge Clinical Trials — Northridge
• Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway — Santa Clarita
• Health Clinical Research, LLC — Cutler Bay
• Brigham and Women's Hospital — Boston
• Revival Research Institute, LLC — Troy
• Stracskin — Portsmouth
• Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue — San Antonio
• … и ещё 1 центр

South Korea · 5 центров

• Chung-Ang University Hospital — Dongjak-gu
• Inha University Hospital — Incheon
• Jeonbuk National University Hospital — Jeonju
• Seoul National University Hospital — Seoul
• Kyung Hee University Hospital at Gangdong — Seoul

Канада · 4 центра

• Kelowna Health and Memory Centre — Kelowna
• Ryan Clinical Research Inc. — Newmarket
• Dar Clinical Research - Ottawa - Hunt Club Road — Ottawa
• SIMa Recherche — Verdun

Китай · 4 центра

• Beijing Friendship Hospital Affiliate of Capital University — Пекин
• Huashan Hospital, Fudan University — Шанхай
• Shanghai Skin Disease Hospital — Шанхай
• Tianjin Medical University General Hospital — Тяньцзинь

Польша · 4 центра

• Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
• Diamond Clinic — Krakow
• Dermedic Jacek Zdybski — Ostrowiec Świętokrzyski
• Centrum Medyczne Ginemedica — Wroclaw

Великобритания · 3 центра

• Royal London Hospital — London
• Chelsea and Westminster Hospital NHS Foundation Trust — London
• Salford Royal Hospital — Salford

Нидерланды · 1 центр

• Erasmus Medisch Centrum — Rotterdam

Идентификаторы

NCT: NCT07533006 · 27772 · J5D-MC-FPAC · 2025-524727-41-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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