Идёт набор NCT07144163
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Atumelnant, Placebo.
- Кому может быть актуально
- Состояния в реестре: Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia. Базовые параметры: 18 лет — 74 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Аргентина, Австралия, Австрия, Бразилия +8
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)
Обзор
The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
Подробное описание
This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study in adult participants (male or female age ≥18 to \<75 years) with classic CAH due to 21-OHD who have been on a stable regimen of GCs for at least 2 months to evaluate efficacy, safety, PK, and PD of atumelnant administered once per day. Following a 3- to 6-week Screening Period, eligible participants will enter the Treatment Period where they will be randomly assigned in a 2:1 ratio to receive either atumelnant 80 mg once daily (with an option for dose escalation to 120 mg once daily at Week 20) or placebo.
A total of approximately 150 participants may be enrolled in the study.
Вмешательства
- Препарат Atumelnant
Atumelnant, tablets, once daily by mouth - Препарат Placebo
Placebo, tablets, once daily by mouth
Первичные конечные точки
- Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement. [Срок оценки: Week 32]
Вторичные конечные точки (4)
- Percent change from baseline of morning pre-GC A4 [Срок оценки: Week 2]
- Percent change from baseline of morning pre-GC 17-OHP [Срок оценки: Week 32]
- Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement [Срок оценки: Week 32]
- Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN [Срок оценки: Week 32]
Критерии участия
Критерии включения
- Male or female, between ≥18 to <75 years of age at the time of signing the ICF.
- Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
- Have classic CAH due to 21-OHD confirmed by the Investigator.
- Participants with Visit 2 levels of morning serum A4 as follows:
- A4 >ULN and treated with <11 mg/m2/day (physiologic) GC doses
- OR normal A4 (>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses
- OR A4 >ULN and treated with ≥11 mg/m2/day GC doses.
- On a stable (defined as no dose change of >5 mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.
- If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.
- If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.
Критерии исключения
- Diagnosis of any form of CAH other than classic 21-OHD.
- History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
- Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
- Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
- Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.
- Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
- Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.
- Severe erythrocytosis as judged by the Investigator.
- Use of atumelnant prior to screening.
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 10 центров
- Crinetics Study Site — Los Angeles
- Crinetics Study Site — Atlanta
- Crinetics Study Site — Chicago
- Crinetics Study Site — Baltimore
- Crinetics Study Site — Ann Arbor
- Crinetics Study Site — Minneapolis
- Crinetics Study Site — Rochester
- Crinetics Study Site — Pittsburgh
- … и ещё 2 центра
Бразилия · 8 центров
- Crinetics Study Site — Fortaleza
- Crinetics Study Site — Curitiba
- Crinetics Study Site — Rio de Janeiro
- Crinetics Study Site — Rio de Janeiro
- Crinetics Study Site — Porto Alegre
- Crinetics Study Site — Botucatu
- Crinetics Study Site — São Paulo
- Crinetics Study Site — São Paulo
Италия · 8 центров
- Crinetics Study Site — Milan
- Crinetics Study Site — Milan
- Crinetics Study Site — Rozzano
- Crinetics Study Site — Modena
- Crinetics Study Site — Padova
- Crinetics Study Site — Palermo
- Crinetics Study Site — Naples
- Crinetics Study Site — Roma
Франция · 6 центров
- Crinetics Study Site — Angers
- Crinetics Study Site — Bron
- Crinetics Study Site — Nantes
- Crinetics Study Site — Paris
- Crinetics Study Site — Pessac
- Crinetics Study Site — Vandœuvre-lès-Nancy
Аргентина · 5 центров
- Crinetics Study Site — Buenos Aires
- Crinetics Study Site — Buenos Aires
- Crinetics Study Site — CABA
- Crinetics Study Site — CABA
- Crinetics Study Site — Córdoba
Австралия · 5 центров
- Crinetics Study Site — Herston
- Crinetics Study Site — Woolloongabba
- Crinetics Study Site — Adelaide
- Crinetics Study Site — Parkville
- Crinetics Study Site — Nedlands
Польша · 3 центра
- Crinetics Study Site — Poznan
- Crinetics Study Site — Warsaw
- Crinetics Study Site — Lodz
Великобритания · 3 центра
- Crinetics Study Site — Cardiff
- Crinetics Study Site — London
- Crinetics Study Site — Manchester
Германия · 2 центра
- Crinetics Study Site — Munich
- Crinetics Study Site — Würzburg
Швеция · 2 центра
- Crinetics Study Site — Gothenburg
- Crinetics Study Site — Stockholm
Австрия · 1 центр
- Crinetics Study Site — Vienna
Нидерланды · 1 центр
- Crinetics Study Site — Leiden
Саудовская Аравия · 1 центр
- Crinetics Study Site — Riyadh
Идентификаторы
NCT: NCT07144163 · CRN04894-12 · 2024-519579-24-00