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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old

RecruitingPhase 2Ages 3 Months - 47 MonthsAllNeurocrine Switzerland GmbH
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In plain words

What the trial is, and whether it could suit you

The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \<4 years of age with CAH.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD) * Have received at least 3 months of hydrocortisone treatment before Day 1, with a stable dose for at least 4 weeks before screening. * Have a body weight of at least 4.5 kilograms (kg) at screening. * Have a newborn screen that is otherwise normal except for elevated 17-OHP or any other abnormality on newborn screen that was cleared upon evaluation by a pediatric specialist. Key Exclusion Criteria: * Have a known or suspected diagnosis of any of the other forms of classic CAH. * Have any condition besides CAH that requires chronic daily therapy with orally administered steroids. * Have any other clinically significant medical condition or chronic disease. Note: Other protocol-defined inclusion and exclusion criteria may apply.
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What it tests

  • Crinecerfont
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Where

11 sites
Neurocrine Clinical Site
San Francisco, United States
Neurocrine Clinical Site
Aurora, United States
Neurocrine Clinical Site
Hartford, United States
Neurocrine Clinical Site
Atlanta, United States
Neurocrine Clinical Site
Chicago, United States
Neurocrine Clinical Site
Indianapolis, United States
Neurocrine Clinical Site
Ann Arbor, United States
Neurocrine Clinical Site
Minneapolis, United States

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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