An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894

NCT06712823 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CRN04894-092024-514846-35-00
• Study Type: interventional
• Target: 150
• Locations: 6 countries
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).

Conditions

Congenital Adrenal Hyperplasia; Classic Congenital Adrenal Hyperplasia

Keywords

Congenital Adrenal Hyperplasia; CAH; CRN04894; atumelnant

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation

  Week 108

• Incidence of glucocorticoid (GC) deficiency / adrenal insufficiency and adrenal crisis

  Week 108

• Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH)

  Week 108

• Change from baseline in morning (before 11:00 AM) serum androstenedione (A4) over time

  Week 108

Secondary Outcomes (2)

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

  Week 108

• Change from baseline in daily glucocorticoid (GC) dose (hydrocortisone [HC] mg equivalents) over time

  Week 108

Study Arms (1)

Treatment

EXPERIMENTAL

Open-label treatment period (up to 2 years). The maximum atumelnant dose permitted is not to exceed the highest atumelnant dose explored in a parent study for the indication.

Drug: atumelnant (CRN04894)

Interventions

atumelnant (CRN04894) DRUG

Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.

Treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all the following criteria apply:
• Participants with CAH who have completed a Crinetics CRN04894 study or completed treatment in a Crinetics CRN04894 study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this extension study.
• Participants must be compliant, in the opinion of the Investigator, with a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone), and be taking a daily dose of hydrocortisone (HC) or equivalent at the time of Informed Consent.
• Female participants who engage in heterosexual intercourse must:
• Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy, tubal ligation for at least 3 months, or bilateral oophorectomy), OR
• Be postmenopausal with at least 1 year of amenorrhea. In participants with less than 1 year of amenorrhea, confirmation is required with 2 follicle-stimulating hormone (FSH) measurements. A documented, historical test result measured prior to Screening may be used as 1 of the 2 measurements. The FSH value should be ≥30 IU/L to confirm menopausal status, OR
• Agree to use a highly effective method of contraception from the beginning of Screening until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Periodic abstinence (ie, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
• Male participants agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile \[ie, vasectomy with a confirmed absence of sperm in ejaculate\]; or agree to remain abstinent on a long-term and persistent basis). Male participants should also agree to not donate sperm for the duration of the study and until at least 2 weeks after the last dose of study drug.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the participant's safety or ability to complete the study.
• Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.
• Participants have any mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.
• Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including being at high risk of adrenal insufficiency as judged by the Investigator.
• Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.
• Participant is an employee or immediate family member of an employee of Crinetics.
• Participants who have been dosed with an investigational drug (other than atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to informed consent or plan to use an investigational drug in another study.
• Participants with a history of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
• Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
• Specific for Participants Not Currently Receiving Atumelnant
• Participants with any clinically significant abnormal laboratory test during Screening or clinically significant concomitant disease other than CAH including but not limited to cardiovascular disease; moderate or severe renal insufficiency (estimated glomerular filtration rate \<60 mL/min/1.73 m2 using Chronic Kidney Epidemiology Collaboration \[CKD-EPI\] formula) at Screening; or Significant liver disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3× upper limit of normal (ULN), and/or total bilirubin \>1.5×ULN during Screening. Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with total bilirubin \<3.5 mg/dL (\<51.3 μmol/L) will be permitted.
• Participants with a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
• Participants with a history of major surgery/surgical therapy for any cause within 4 weeks prior to Screening.
• Participants with poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol/mL).

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (9)

Crinetics Study Site, Minneapolis, Minnesota 55454

Minneapolis, Minnesota, 55455, United States

ACTIVE NOT RECRUITING

Crinetics Study Site

Morehead City, North Carolina, 28557, United States

ACTIVE NOT RECRUITING

Crinetics Study Site

Córdoba, Córdoba Province, 5000, Argentina

RECRUITING

Crinetics Study Site

Botucatu, São Paulo, 18618-686, Brazil

RECRUITING

Crinetics Study Site

São Paulo, 05403-000, Brazil

RECRUITING

Crinetics Study Site

Munich, Bavaria, 80336, Germany

RECRUITING

Crinetics Study Site

Roma, 00161, Italy

RECRUITING

Crinetics Study Site

Birmingham, CV22DX, United Kingdom

RECRUITING

Crinetics Study Site

London, NW1 2BU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Crinetics Clinical Trials Crinetics Clinical Trials

CONTACT

833-827-9741; clinicaltrials@crinetics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); US (2); IT (1); AR (1); BR (2); DE (1)