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Clinical Trials in the UK / NCT04490915
Active, not recruiting Phase 3

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

NCT04490915 · tracked via the Priya Life Science UK tracker
Sponsor
Neurocrine Biosciences
Phase
Phase 3
Started
2020-12-16
Last updated
2026-05-11

Condition(s) studied

Congenital Adrenal Hyperplasia

Investigational drug(s) / intervention(s)

CrinecerfontPlacebo

Crinecerfont: CRF type 1 receptor antagonist

Placebo: Non-active dosage form

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit. 2. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency. 3. Be on a stable steroid regimen. 4. Participants of childbearing potential must agree to use an acceptable method of contraception during the study. Exclusion Criteria: 1. Have a diagnosis of any of the other known forms of classic CAH. 2. Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy. 3. Have a clinically significant unstable medical condition or chronic disease other than CAH. 4. Have a history of cancer unless considered cured. 5. Are pregnant. 6. Have a known history of clinically significant arrhythmia or abnormalities on ECG. 7. Have a known hypersensitivity to any corticotropin releasing hormone receptor antagonists. 8. 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. 9. Have current substance dependence, or current substance (drug) or alcohol abuse. 10. Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
Neurocrine Clinical Site Los Angeles California
Neurocrine Clinical Site San Diego California
Neurocrine Clinical Site San Francisco California
Neurocrine Clinical Site Aurora Colorado
Neurocrine Clinical Site Atlanta Georgia
Neurocrine Clinical Site Indianapolis Indiana
Neurocrine Clinical Site Bethesda Maryland
Neurocrine Clinical Site Boston Massachusetts
Neurocrine Clinical Site Ann Arbor Michigan
Neurocrine Clinical Site Minneapolis Minnesota
Neurocrine Clinical Site Rochester Minnesota
Neurocrine Clinical Site St Louis Missouri
Neurocrine Clinical Site Great Neck New York
Neurocrine Clinical Site New York New York
Neurocrine Clinical Site Winston-Salem North Carolina
Neurocrine Clinical Site Tulsa Oklahoma
Neurocrine Clinical Site Philadelphia Pennsylvania
Neurocrine Clinical Site Pittsburgh Pennsylvania
Neurocrine Clinical Site Dallas Texas
Neurocrine Clinical Site Seattle Washington
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
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

+ 30 more sites — see the full list on the official registry below.

More Neurocrine Biosciences trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04490915 on ClinicalTrials.gov ↗ ← All trials in the UK