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Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
Sponsor: Neurocrine Biosciences
Summary
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
103
Start Date
2021-06-25
Completion Date
2027-08
Last Updated
2025-02-05
Healthy Volunteers
No
Conditions
Interventions
Crinecerfont
CRF type 1 receptor antagonist
Placebo
Non-active dosage form
Locations (46)
Neurocrine Clinical Site
Birmingham, Alabama, United States
Neurocrine Clinical Site
Los Angeles, California, United States
Neurocrine Clinical Site
Orange, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
San Francisco, California, United States
Neurocrine Clinical Site
Aurora, Colorado, United States
Neurocrine Clinical Site
Hartford, Connecticut, United States
Neurocrine Clinical Site
Washington D.C., District of Columbia, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Indianapolis, Indiana, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
Minneapolis, Minnesota, United States
Neurocrine Clinical site
St Louis, Missouri, United States
Neurocrine Clinical Site
New Hyde Park, New York, United States
Neurocrine Clinical Site
New York, New York, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Tulsa, Oklahoma, United States
Neurocrine Clinical Site
Philadelphia, Pennsylvania, United States
Neurocrine Clinical Site
Pittsburgh, Pennsylvania, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Seattle, Washington, United States
Neurocrine Clinical Site
Brussels, Belgium
Neurocrine Clinical Site
Ghent, Belgium
Neurocrine Clinical Site
Edmonton, Alberta, Canada
Neurocrine Clinical Site
Vancouver, British Columbia, Canada
Neurocrine Clinical Site
Montreal, Quebec, Canada
Neurocrine Clinical Site
Angers, France
Neurocrine Clinical Site
Bordeau, France
Neurocrine Clinical Site
Le Kremlin-Bicêtre, France
Neurocrine Clinical Site
Paris, France
Neurocrine Clinical Site
Paris, France
Neurocrine Clinical Site
Berlin, Germany
Neurocrine Clinical Site
Heidelberg, Germany
Neurocrine Clinical Site
Magdeburg, Germany
Neurocrine Clinical Site
Athens, Greece
Neurocrine Clinical Site
Athens, Greece
Neurocrine Clinical Site
Bologna, Italy
Neurocrine Clinical Site
Milan, Italy
Neurocrine Clinical Site
Naples, Italy
Neurocrine Clinical Site
Roma, Italy
Neurocrine Clinical Site
Gdansk, Poland
Neurocrine Clinical Site
Rzeszów, Poland
Neurocrine Clinical Site
Barcelona, Spain
Neurocrine Clinical Site
Seville, Spain
Neurocrine Clinical Site
London, United Kingdom