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Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
Sponsor: Neurocrine Biosciences
Summary
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active 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 20 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 Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2020-12-16
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 (70)
Neurocrine Clinical Site
Los Angeles, California, United States
Neurocrine Clinical Site
San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Atlanta, Georgia, United States
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Indianapolis, Indiana, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
Neurocrine Clinical Site
St Louis, Missouri, United States
Neurocrine Clinical Site
Great Neck, New York, United States
Neurocrine Clinical Site
New York, New York, United States
Neurocrine Clinical Site
Winston-Salem, North Carolina, United States
Neurocrine Clinical Site
Tulsa, Oklahoma, United States
Neurocrine Clinical Site
Philadelphia, Pennsylvania, United States
Neurocrine Clinical Site
Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Seattle, Washington, United States
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Graz, Austria
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Vienna, Austria
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Brussels, Belgium
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Leuven, Belgium
Neurocrine Clinical Site
Sofia, Bulgaria
Neurocrine Clinical Site
Sofia, Bulgaria
Neurocrine Clinical Site
Halifax, Nova Scotia, Canada
Neurocrine Clinical Site
Hradec Králové, Czechia
Neurocrine Clinical Site
Angers, France
Neurocrine Clinical Site
Grenoble, France
Neurocrine Clinical Site
Le Kremlin-Bicêtre, France
Neurocrine Clinical Site
Nantes, France
Neurocrine Clinical Site
Paris, France
Neurocrine Clinical Site
Paris, France
Neurocrine Clinical Site
Dresden, Germany
Neurocrine Clinical Site
Essen, Germany
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Frankfurt, Germany
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Leipzig, Germany
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Munich, Germany
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Thessaloniki, Greece
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Afula, Israel
Neurocrine Clinical Site
Beersheba, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Ancona, Italy
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Bologna, Italy
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Florence, Italy
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Messina, Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Padova, Italy
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Roma, Italy
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Leiden, Netherlands
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Krakow, Poland
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Poznan, Poland
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Warsaw, Poland
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Porto, Portugal
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Belgrade, Serbia
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Madrid, Spain
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Seville, Spain
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Gothenburg, Sweden
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Stockholm, Sweden
Neurocrine Clinical Site
Cardiff, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
Neurocrine Clinical Site
Salford, United Kingdom