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Corticosteroid

Crinecerfont for Congenital Adrenal Hyperplasia (CAHtalyst Trial)

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

Be on a stable regimen of steroidal treatment for CAH.

Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 24

Awards & highlights

CAHtalyst Trial Summary

This trial is testing a new drug for people with classic CAH due to 21-hydroxylase deficiency. The trial will last about 20 months and will compare the new drug to a placebo.

Who is the study for?

Adults with classic Congenital Adrenal Hyperplasia (CAH) due to 21-hydroxylase deficiency can join. They must be on stable CAH medication, agree to use contraception if they can have children, and follow study rules. Excluded are those with unstable conditions, hypersensitivity to similar drugs, certain medical histories like cancer or chronic glucocorticoid therapy needs.Check my eligibility

What is being tested?

The trial is testing Crinecerfont against a placebo for CAH over 24 weeks in a double-blind setup where neither the participants nor the researchers know who gets what. After this phase, there's an open-label period where everyone receives Crinecerfont for up to three years.See study design

What are the potential side effects?

While specific side effects of Crinecerfont aren't listed here, common ones may include reactions at the injection site, hormonal imbalances leading to mood changes or skin issues, and potential risks associated with long-term hormone therapy.

CAHtalyst Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on a consistent dose of steroids for congenital adrenal hyperplasia.

Select...

I have been diagnosed with classic 21-hydroxylase deficiency CAH.

CAHtalyst Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline in glucocorticoid daily dose at Week 24

Secondary outcome measures

Achievement of a reduction in glucocorticoid daily dose to physiologic levels at Week 24

Change from baseline in blood pressure at Week 24

Change from baseline in body weight at Week 24

+7 more

CAHtalyst Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CrinecerfontExperimental Treatment1 Intervention

Crinecerfont capsule, administered orally, twice daily for 24 weeks during the placebo-controlled treatment period, followed by active treatment with crinecerfont for at least 1 year.

Group II: PlaceboPlacebo Group2 Interventions

Placebo capsule, administered orally, twice daily for 24 weeks, followed by active treatment with crinecerfont for at least 1 year.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor

75 Previous Clinical Trials

6,569 Total Patients Enrolled

Clinical Development LeadStudy DirectorNeurocrine Biosciences

24 Previous Clinical Trials

2,395 Total Patients Enrolled

Media Library

Crinecerfont (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04490915 — Phase 3

Congenital Adrenal Hyperplasia Research Study Groups: Crinecerfont, Placebo

Congenital Adrenal Hyperplasia Clinical Trial 2023: Crinecerfont Highlights & Side Effects. Trial Name: NCT04490915 — Phase 3

Crinecerfont (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04490915 — Phase 3

Frequently Asked Questions

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

Do many hospitals in North America conduct this research?

"Enrolling patients from 21 different locations, this study offers patients the convenience of being able to choose a site near them to participate. Some of these locations include Aurora, San Diego and Bethesda."

Answered by AI

How many people are being given this new medication to test?

"That is correct. The clinical trial is presently looking for candidates, as indicated by the data on clinicaltrials.gov. The trial was initially posted on 7/23/2020 and was most recently updated on 9/14/2022. The trial is looking for 165 patients at 21 locations."

Answered by AI

Are researchers looking for new participants in this clinical trial?

"Yes, the trial is still open for recruitment according to the information available on clinicaltrials.gov. The posting date was July 23rd, 2020 and the most recent update was September 14th, 2020. They are hoping to enroll 165 patients from 21 different sites."

Answered by AI

When might the FDA green-light Crinecerfont?

"Crinecerfont has received a safety score of 3. This is based on it being a Phase 3 trial, which provides some evidence of efficacy as well as multiple rounds of data indicating safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04490915.

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