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

Last updated: November 22, 2024
Sponsor: Crinetics Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Congenital Adrenal Hyperplasia

Male Hormonal Deficiencies/abnormalities

Treatment

CRN04894

Clinical Study ID

NCT05907291
CRN04894-03
2023-503488-40-00
  • Ages 16-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female participants ≥18 to 75 years of age at the time of signing theInformed Consent Form (ICF). Participants ≥16 years of age may be included in siteslocated 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 (ifapplicable) regimen during the Screening Period

  5. Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, amean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalentswill be used for inclusion

  6. If on estrogen therapy (any route), dose must be stable for at least 3 months priorto Screening

Exclusion

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 requiringchronic 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 toScreening

  7. Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, orwith 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 notevaluable (eg, due to hemoglobinopathies)

  9. Participants with hypothyroidism who are not receiving adequate hormone replacementtherapy based on thyroid hormone levels measured at the time of Screening

  10. History of unstable angina or acute myocardial infarction within 12 weeks prior toScreening or other clinically significant cardiac disease at the time of Screening

  11. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma orcervical 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, orgrowth hormone

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: CRN04894
Phase: 2
Study Start date:
July 03, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Crinetics Study Site

    Córdoba, Córdoba Province 5000
    Argentina

    Active - Recruiting

  • Crinetics Study Site

    Buenos Aires, C1180
    Argentina

    Active - Recruiting

  • Crinetics Study Site

    Curitiba, Paraná 80030-110
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Porto Alegre, Rio Grande Do Sul 90410-000
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Botucatu, São Paulo 18618-686
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Rio De Janeiro, 20231-092
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    São Paulo, 04024-002
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Munich, Bavaria 80336
    Germany

    Active - Recruiting

  • Crinetics Study Site

    Bangalore, Karnataka 560054
    India

    Active - Recruiting

  • Crinetics Study Site

    Vellore, Tamil Nadu 632004
    India

    Active - Recruiting

  • Crinetics Study Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Roma, 00161
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Sheffield, South Yorkshire S10 2RX
    United Kingdom

    Active - Recruiting

  • Crinetics Study Site

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Crinetics Study Site

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Crinetics Study Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Crinetics Study Site

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

  • Crinetics Study Site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Crinetics Study Site

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Crinetics Study Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Crinetics Study Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Crinetics Study Site

    East Providence, Rhode Island 02915
    United States

    Active - Recruiting

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