← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52

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.

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA's stance on Crinecerfont?

"Crinecerfont's safety is estimated to be a 3."

Answered by AI

What is the estimated participant count for this clinical trial?

"That is correct. The clinicaltrials.gov website has the most recent information on this topic, which indicates that as of 8/30/2022, this study was still recruiting patients that had first been posted about on 6/24/2021. They are looking for a total of 81 participants at 24 different sites."

Answered by AI

How do I sign up for the opportunity to participate in this research?

"This clinical trial is meant for children aged 2-17 who have hyperplasia. They are currently recruiting around 81 participants."

Answered by AI

Can new patients sign up for this research study?

"That is correct, the listing on clinicaltrials.gov currently says that this trial is actively recruiting patients. This particular trial was originally posted on June 24th, 2021 and was last updated on August 30th, 2022. The team running the trial are looking for a total of 81 participants which will be spread out across 24 different locations."

Answered by AI

Could you tell me how many different facilities are coordinating this trial?

"There are 24 sites enrolling patients for this study, which seeks to minimize travel requirements for participants by being located in or near major cities such as Hartford, Oklahoma City and Indianapolis."

Answered by AI

Does this research involve testing on elderly individuals?

"According to the inclusion criteria, patients who want to enroll in this trial must be between 2 and 17 years old. Out of the 29 clinical trials catering to children, this is one of 114 for senior citizens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

2021. "Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04806451.

All > Cushings Syndrome