Atumelnant for Congenital Adrenal Hyperplasia

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Crinetics Pharmaceuticals Inc.

Must be taking: Glucocorticoids

Disqualifiers: Alcohol or drug abuse, Cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Do I have to stop taking my current medications for the trial?

The trial requires participants to continue their current glucocorticoid replacement therapy (like hydrocortisone) as part of the study. There is no mention of stopping other medications, so it's best to discuss your specific situation with the study team.

Research Team

Eligibility Criteria

This trial is for individuals with Congenital Adrenal Hyperplasia who have been stable on glucocorticoid replacement therapy. Women must be nonchildbearing or use contraception, and men must use condoms or abstain. Participants should not have uncontrolled diabetes, recent major surgery, mental conditions affecting study comprehension, known allergies to test materials, substance abuse issues, significant abnormal lab tests or certain heart conditions.

Inclusion Criteria

I am consistently taking my prescribed glucocorticoid medication as directed.

I am either not able to have children, use effective birth control, or use condoms.

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.

Exclusion Criteria

Participant is an employee or immediate family member of an employee of Crinetics.

I have a condition that requires me to take steroids regularly.

My diabetes is not well-managed, with an HbA1c level of 8.5% or higher.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label treatment with atumelnant (CRN04894) for up to 2 years

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• atumelnant (CRN04894) (Monoclonal Antibodies)

Trial Overview The trial is testing the long-term safety and effectiveness of a drug called atumelnant (CRN04894) for treating Congenital Adrenal Hyperplasia. It's an extension study which means it continues from previous research where this medication was used.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Crinetics Pharmaceuticals Inc.

Lead Sponsor

Trials

13

Recruited

760+