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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Congenital Adrenal Hyperplasia

In brief

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).

Key facts

Study ID

NCT04490915

Run by

Neurocrine Biosciences

People needed

182

Starts

2020-12-16

Expected to finish

2027-08-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit.
• Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency.
• Be on a stable steroid regimen.
• Participants of childbearing potential must agree to use an acceptable method of contraception during the study.

You may not qualify if…

• Have a diagnosis of any of the other known forms of classic CAH.
• Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
• Have a clinically significant unstable medical condition or chronic disease other than CAH.
• Have a history of cancer unless considered cured.
• Are pregnant.
• Have a known history of clinically significant arrhythmia or abnormalities on ECG.
• Have a known hypersensitivity to any corticotropin releasing hormone receptor antagonists.
• Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
• Have current substance dependence, or current substance (drug) or alcohol abuse.
• Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.

Where it is running

• 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 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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