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Monoclonal Antibodies

Atumelnant for Congenital Adrenal Hyperplasia

Phase 2

Recruiting

Research Sponsored by Crinetics Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Participants with a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.

Participants with poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol/mL).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to assess how safe and effective atumelnant (CRN04894) is over a long period of time."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, the trial aims to monitor the long-term safety and tolerability of atumelnant (CRN04894), suggesting that participants will be closely observed for any adverse reactions over time.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I understand the study and can follow medical instructions.

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I am not pregnant or breastfeeding and willing to use effective birth control.

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I haven't taken any experimental drugs recently, except atumelnant.

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I am not currently institutionalized by order of judicial or administrative authorities.

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My heart's electrical activity, measured by ECG, does not meet specific normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 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.

0 / 7Eligibility criteria met