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Evaluating CRN04894 for treating congenital adrenal hyperplasia

A 12-week, Phase 2 Open-label, Sequential Dose Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 Treatment in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

Phase 2 Interventional Crinetics Pharmaceuticals Inc. · NCT05907291

This study is testing a new drug called CRN04894 to see if it can safely help people with classic congenital adrenal hyperplasia feel better over 12 weeks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment30 (estimated)
Ages16 Years to 75 Years
SexAll
SponsorCrinetics Pharmaceuticals Inc. Industry-sponsored
Drugs / interventionsprednisone
Locations26 sites (Pasadena, California and 25 other locations)
Trial IDNCT05907291 on ClinicalTrials.gov

What this trial studies

This Phase 2, open-label study aims to assess the safety, efficacy, and pharmacokinetics of CRN04894 in individuals with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. Participants will receive the treatment for 12 weeks, and the study will enroll approximately 30 individuals. The study will focus on how well the drug works and its effects on the body.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with classic 21-hydroxylase deficiency who are on a stable glucocorticoid replacement regimen.

Not a fit: Patients with other forms of congenital adrenal hyperplasia or those who have used dexamethasone recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve management and outcomes for patients with congenital adrenal hyperplasia.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating congenital adrenal hyperplasia with novel therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States
2. Classic 21-hydroxylase deficiency
3. On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone)
4. Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period
5. Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, a mean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalents will be used for inclusion
6. If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening

Exclusion Criteria:

1. Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
2. Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4, dexamethasone is permitted
3. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
4. Night shift workers or any other reason for abnormal sleep/wake cycles
5. Clinically significant unstable medical condition or chronic disease other than CAH
6. History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening
7. Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with change in total daily insulin dose by \>15% within 6 weeks prior to Screening
8. Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%(≥69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathies)
9. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening
10. History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening
11. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
12. Pregnant or lactating
13. Known history of illicit drug or alcohol abuse within the last year
14. Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide)
15. Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone

Where this trial is running

Pasadena, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Congenital Adrenal HyperplasiaClassic Congenital Adrenal HyperplasiaCAHTouCAHnCRN04894
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.