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NCT04490915 · ClinicalTrials.gov registry record · Phase 3
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
A Phase 3 study of Congenital Adrenal Hyperplasia, sponsored by Neurocrine Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 182
- Enrollment target
- 20
- Study locations
NCT04490915 is a Phase 3 study of Congenital Adrenal Hyperplasia that is active but no longer recruiting, run by Neurocrine Biosciences. The registered enrollment target is 182 participants, above the 80-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (127% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT04490915, a Phase 3 study of Congenital Adrenal Hyperplasia, is active but no longer recruiting, sponsored by Neurocrine Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 182 participants
- Enrollment target
- 20
- Study locations
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Crinecerfont
Study Locations (20)
California
- Neurocrine Clinical Site - Los Angeles
- Neurocrine Clinical Site - San Diego
- Neurocrine Clinical Site - San Francisco
Minnesota
- Neurocrine Clinical Site - Minneapolis
- Neurocrine Clinical Site - Rochester
New York
- Neurocrine Clinical Site - Great Neck
- Neurocrine Clinical Site - New York
Pennsylvania
- Neurocrine Clinical Site - Philadelphia
- Neurocrine Clinical Site - Pittsburgh
Colorado
- Neurocrine Clinical Site - Aurora
Georgia
- Neurocrine Clinical Site - Atlanta
Indiana
- Neurocrine Clinical Site - Indianapolis
Maryland
- Neurocrine Clinical Site - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2027-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04490915
The ClinicalTrials.gov registry entry for NCT04490915 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 80-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (127% higher). The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Congenital Adrenal Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04490915 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT04490915 about?
NCT04490915 is a clinical study titled "Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia". 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 ...
What is the current status of trial NCT04490915?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2020-12-16. Estimated completion is 2027-08.
What conditions does trial NCT04490915 study?
This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia.
What interventions are being tested in trial NCT04490915?
The interventions under investigation include: Placebo (DRUG), Crinecerfont (DRUG).
Who is sponsoring clinical trial NCT04490915?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04490915 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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