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Corticosteroid

CRN04894 for Congenital Adrenal Hyperplasia

Phase 2

Recruiting

Research Sponsored by Crinetics Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Classic 21-hydroxylase deficiency

Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Study Summary

This trial will test a new drug for safety, effectiveness & how it works in people with a type of adrenal disorder.

Who is the study for?

Adults aged 18-75 with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency can join. They must be on stable glucocorticoid and, if needed, mineralocorticoid replacement therapy. Exclusions include major recent surgery, unstable heart conditions, certain drug use including testosterone or insulin changes for diabetes within the last six weeks.Check my eligibility

What is being tested?

The trial is testing CRN04894's safety and effectiveness in managing CAH symptoms and how the body processes it. It's an open-label study where all participants know they're receiving CRN04894 at various doses to find the right balance between benefits and side effects.See study design

What are the potential side effects?

Potential side effects of CRN04894 are not detailed here but generally could include reactions related to hormone levels adjustment such as fatigue, mood swings, weight changes or skin issues since it targets adrenal gland function.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with classic 21-hydroxylase deficiency.

Select...

I take at least 15 mg of hydrocortisone daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 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 morning (before 11:00) serum androstenedione (A4)

Incidence of treatment-emergent adverse events (TEAEs) throughout the study

Secondary outcome measures

Change from baseline in morning (before 11:00) serum 17-hydroxyprogesterone (17-OHP)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sequential DoseExperimental Treatment1 Intervention

Sequential, open-label, 12-week fixed-dose cohorts.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Crinetics Pharmaceuticals Inc.Lead Sponsor

11 Previous Clinical Trials

581 Total Patients Enrolled

Media Library

CRN04894 (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05907291 — Phase 2

Congenital Adrenal Hyperplasia Research Study Groups: Sequential Dose

Congenital Adrenal Hyperplasia Clinical Trial 2023: CRN04894 Highlights & Side Effects. Trial Name: NCT05907291 — Phase 2

CRN04894 (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05907291 — Phase 2

Frequently Asked Questions

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

What potential adverse effects should patients be aware of when undergoing Sequential Dose treatment?

"There is some evidence indicating Sequential Dose's safety, so it was assigned a rating of 2. As this is only Phase 2 in the clinical trials process, there is yet to be any empirical data that demonstrates its efficacy."

Answered by AI

Is this experiment suitable for individuals aged sixty and above?

"This trial has an age-range of 16 to 75 years old. Subsequently, there are 25 clinical trials for those younger than this boundary and 108 studies catering to seniors aged 65 or older."

Answered by AI

Can patients still join this experiment?

"Affirmative. According to clinicaltrials.gov, this medical research is presently searching for volunteers; it was initially posted on July 3rd 2023 and most recently adjusted on July 12th 2023. Approximately 30 subjects need to be recruited across 1 centre."

Answered by AI

How many research participants are involved in this experiment?

"Affirmative. According to the details published on clinicaltrials.gov, this scientific study commenced its recruitment process on July 3rd 2023 and is still actively recruiting participants as of July 12th 2023. The investigators are aiming to enrol 30 individuals at a single medical centre."

Answered by AI

Is it feasible to join this experiment?

"This clinical trial is enrolling 30 individuals between 16-75 years old who are diagnosed with congenital adrenal hyperplasia.To be eligible for the study, participants need to meet these criteria: Male or female subjects aged 18 and older (or those over 16 in US states) exhibiting Classic 21-hydroxylase deficiency, on a consistent glucocorticoid replacement dose of at least 15mg hydrocortisone per day (or equivalent), stable estrogen therapy if applicable within 3 months preceding screening, as well as compliant mineralocorticoid treatment where necessary."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

2023. "Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05907291.

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