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ACTIVE NOT RECRUITING
NCT04490915
PHASE3

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

Sponsor: Neurocrine Biosciences

View on ClinicalTrials.gov

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

Interventions

DRUG

Crinecerfont

CRF type 1 receptor antagonist

DRUG

Placebo

Non-active dosage form

Locations (70)

Neurocrine Clinical Site

Los Angeles, 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

Atlanta, Georgia, United States

Neurocrine Clinical Site

Indianapolis, Indiana, United States

Neurocrine Clinical Site

Bethesda, Maryland, 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

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

Neurocrine Clinical Site

Dallas, Texas, United States

Neurocrine Clinical Site

Seattle, Washington, United States

Neurocrine Clinical Site

Graz, Austria

Neurocrine Clinical Site

Vienna, Austria

Neurocrine Clinical Site

Brussels, Belgium

Neurocrine Clinical Site

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

Neurocrine Clinical Site

Frankfurt, Germany

Neurocrine Clinical Site

Leipzig, Germany

Neurocrine Clinical Site

Munich, Germany

Neurocrine Clinical Site

Athens, Greece

Neurocrine Clinical Site

Athens, Greece

Neurocrine Clinical Site

Athens, Greece

Neurocrine Clinical Site

Thessaloniki, Greece

Neurocrine Clinical Site

Afula, Israel

Neurocrine Clinical Site

Beersheba, Israel

Neurocrine Clinical Site

Petah Tikva, Israel

Neurocrine Clinical Site

Tel Aviv, Israel

Neurocrine Clinical Site

Ancona, Italy

Neurocrine Clinical Site

Bologna, Italy

Neurocrine Clinical Site

Florence, Italy

Neurocrine Clinical Site

Messina, Italy

Neurocrine Clinical Site

Milan, Italy

Neurocrine Clinical Site

Milan, Italy

Neurocrine Clinical Site

Naples, Italy

Neurocrine Clinical Site

Padova, Italy

Neurocrine Clinical Site

Roma, Italy

Neurocrine Clinical Site

Leiden, Netherlands

Neurocrine Clinical Site

Krakow, Poland

Neurocrine Clinical Site

Poznan, Poland

Neurocrine Clinical Site

Warsaw, Poland

Neurocrine Clinical Site

Porto, Portugal

Neurocrine Clinical Site

Belgrade, Serbia

Neurocrine Clinical Site

Madrid, Spain

Neurocrine Clinical Site

Seville, Spain

Neurocrine Clinical Site

Gothenburg, Sweden

Neurocrine Clinical Site

Stockholm, Sweden

Neurocrine Clinical Site

Cardiff, United Kingdom

Neurocrine Clinical Site

London, United Kingdom

Neurocrine Clinical Site

Manchester, United Kingdom

Neurocrine Clinical Site

Salford, United Kingdom