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

Congenital Adrenal Hyperplasia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907291
• Other study ID #: CRN04894-03
• Secondary ID: 2023-503488-40-0
• Status: Recruiting
• Phase: Phase 2
• Start date: July 3, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Crinetics Pharmaceuticals Inc.
• Contact: Crinetics Clinical Trials
• Phone: 833-827-9741
• Email: clinicaltrials[@]crinetics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of CRN04894 in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.

Description:

This Phase 2, open-label, sequential dose cohort study will evaluate the efficacy, safety, PK, and PD of CRN04894 when administered for 12 weeks in participants with CAH caused by 21-hydroxylase deficiency. Up to approximately 30 participants will be enrolled in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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)

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

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

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• Congenital Adrenal Hyperplasia
• Hyperplasia

Intervention

Drug:
• CRN04894
CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.

Locations

Country	Name	City	State
Argentina	Crinetics Study Site	Buenos Aires
Argentina	Crinetics Study Site	Córdoba	Córdoba Province
Brazil	Crinetics Study Site	Botucatu	São Paulo
Brazil	Crinetics Study Site	Curitiba	Paraná
Brazil	Crinetics Study Site	Porto Alegre	Rio Grande Do Sul
Brazil	Crinetics Study Site	Ribeirão Preto	São Paulo
Brazil	Crinetics Study Site	Rio De Janeiro
Brazil	Crinetics Study Site	Rio De Janeiro
Brazil	Crinetics Study Site	São Paulo
India	Crinetics Study Site	Vellore	Tamil Nadu
Italy	Crinetics Study Site	Napoli
Italy	Crinetics Study Site	Roma
Italy	Crinetics Study Site	Rozzano
United Kingdom	Crinetics Study Site	London
United States	Crinetics Study Site	Ann Arbor	Michigan
United States	Crinetics Study Site	Minneapolis	Minnesota
United States	Crinetics Study Site	Morehead City	North Carolina
United States	Crinetics Study Site	Pasadena	California
United States	Crinetics Study Site	Philadelphia	Pennsylvania
United States	Crinetics Study Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Crinetics Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  India,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in morning (before 11:00) serum androstenedione (A4)		Week 12
Primary	Incidence of treatment-emergent adverse events (TEAEs) throughout the study		Week 12
Secondary	Change from baseline in morning (before 11:00) serum 17-hydroxyprogesterone (17-OHP)		Week 12