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

Primary Purpose

Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CRN04894
Sponsored by
Crinetics Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Adrenal Hyperplasia

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Classic 21-hydroxylase deficiency On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone) Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent) If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening Exclusion Criteria: Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency Dexamethasone use within 30 days of Screening History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy Night shift workers or any other reason for abnormal sleep/wake cycles Clinically significant unstable medical condition or chronic disease other than CAH History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening 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 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) Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening 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 History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ Pregnant or lactating Known history of illicit drug or alcohol abuse within the last year Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide) Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone

Sites / Locations

  • Crinetics Study SiteRecruiting
  • Crinetics Study SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential Dose

Arm Description

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

Outcomes

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)

Full Information

First Posted
June 8, 2023
Last Updated
September 11, 2023
Sponsor
Crinetics Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05907291
Brief Title
Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crinetics Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential Dose
Arm Type
Experimental
Arm Description
Sequential, open-label, 12-week fixed-dose cohorts.
Intervention Type
Drug
Intervention Name(s)
CRN04894
Intervention Description
CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.
Primary Outcome Measure Information:
Title
Change from baseline in morning (before 11:00) serum androstenedione (A4)
Time Frame
Week 12
Title
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in morning (before 11:00) serum 17-hydroxyprogesterone (17-OHP)
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Classic 21-hydroxylase deficiency On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone) Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent) If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening Exclusion Criteria: Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency Dexamethasone use within 30 days of Screening History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy Night shift workers or any other reason for abnormal sleep/wake cycles Clinically significant unstable medical condition or chronic disease other than CAH History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening 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 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) Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening 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 History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ Pregnant or lactating Known history of illicit drug or alcohol abuse within the last year Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide) Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Crinetics Clinical Trials
Phone
833-827-9741
Email
clinicaltrials@crinetics.com
Facility Information:
Facility Name
Crinetics Study Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
Crinetics Study Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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