A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata

Официальное название

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA

Обзор

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA). This study is seeking participants who are * 12 years or older (if permitted by the local IRB/EC and local regulatory health authority) * have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less * do not have any other diseases or conditions affecting hair loss. Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks. About 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone. We will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.

Вмешательства

• Препарат Ritlecitinib 100 mg
  100 mg capsule taken orally once daily
• Препарат Ritlecitinib 50 mg
  50 mg capsule taken orally once daily
• Другое Placebo
  Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily

Первичные конечные точки

• Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo [Срок оценки: Week 24]

Вторичные конечные точки (12)

• Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus [Срок оценки: Week 24]
• Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus [Срок оценки: Week 24]
• Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus [Срок оценки: Week 24]
• Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus [Срок оценки: Week 24]
• Difference in the mean change from baseline (CFB) in SALT score at applicable timepoints through Week 24 for ritlecitinib 50 mg QD versus placebo [Срок оценки: Weeks 8, 12, 18 and 24]
• Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at Week 24 between ritlecitinib 50 mg QD versus placebo [Срок оценки: Week 24]
• Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo [Срок оценки: Weeks 8, 12, 18]
• Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo [Срок оценки: Weeks 8, 12, 18]
• Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo [Срок оценки: Weeks 8, 12, 18]
• Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo [Срок оценки: Weeks 8, 12, 18]
• Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo [Срок оценки: Weeks 8, 12, 18]
• Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo [Срок оценки: Weeks 8, 12, 18]

Критерии участия

Критерии включения

• 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled
• Have a clinical diagnosis of AA with no other etiology of hair loss.
• Have >20% to <50% hair loss of the scalp, as measured by SALT.
• Current AA episode of hair loss ≥6 months and ≤10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches).

Критерии исключения

1\. Diseases or conditions affecting hair loss, including:

• Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.
• Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.).
• Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).

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 · 4 центра

• Dawes Fretzin Clinical Research Group, LLC — Indianapolis
• University of Iowa Hospitals & Clinics — Iowa City
• Center for Clinical Studies - Houston - Binz Street — Houston
• Center for Clinical Studies, LTD. LLP — Houston

Идентификаторы

NCT: NCT07733765 · B7981110

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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