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Corticosteroid

Crinecerfont for Congenital Adrenal Hyperplasia

Phase 3
Waitlist Available
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a medically confirmed diagnosis of 21-hydroxylase deficiency CAH.
Be on a stable regimen of steroidal treatment for CAH.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights

Study Summary

This trial is testing a new drug for children with a hormone disorder. It will last about 14 months and compare the new drug to a placebo.

Who is the study for?
This trial is for pediatric patients with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. Participants must be on stable steroidal treatment, have high androgen levels, and agree to birth control if applicable. Exclusions include unstable medical conditions, cancer history unless cured, recent investigational drug use or significant blood loss, other CAH forms, known drug hypersensitivity, certain surgeries or chronic conditions.Check my eligibility
What is being tested?
The study tests the effectiveness of Crinecerfont compared to a placebo in children with CAH over a period of 28 weeks. After this phase, all participants receive Crinecerfont for another 24 weeks. Those interested can join an open-label extension for about three years to further assess long-term effects.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such trials monitor for adverse reactions related to the medication under investigation which could range from mild symptoms like headaches or nausea to more serious issues depending on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with 21-hydroxylase deficiency CAH.
Select...
I am on a consistent dose of steroids for congenital adrenal hyperplasia.
Select...
My androgen levels are high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Serum Androstenedione (A4) at Week 4
Secondary outcome measures
Achievement of a reduction in glucocorticoid daily dose to physiologic levels at Week 28
17-alpha-hydroxyprogesterone
Change from baseline in body mass index at Week 28
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CrinecerfontExperimental Treatment1 Intervention
Crinecerfont solution or capsule, administered orally, twice daily for 28 weeks during the placebo-controlled treatment period, followed by active treatment with crinecerfont for at least 24 weeks.
Group II: PlaceboPlacebo Group2 Interventions
Placebo solution or capsule, administered orally, twice daily for 28 weeks, followed by active treatment with crinecerfont for at least 24 weeks.

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,648 Total Patients Enrolled
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,474 Total Patients Enrolled

Media Library

Crinecerfont (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04806451 — Phase 3
Congenital Adrenal Hyperplasia Research Study Groups: Crinecerfont, Placebo
Congenital Adrenal Hyperplasia Clinical Trial 2023: Crinecerfont Highlights & Side Effects. Trial Name: NCT04806451 — Phase 3
Crinecerfont (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04806451 — Phase 3
~26 spots leftby Jun 2025
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