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Study on the Safety and Effectiveness of CRN04894 for Patients with Congenital Adrenal Hyperplasia

Verified siteFast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Congenital Adrenal Hyperplasia, a rare condition in which the adrenal glands do not make enough hormones, leading to problems with growth and metabolism. Participants will receive the oral medication atumelnant, which is supplied as tablets taken by mouth.

The main aim of the trial is to learn whether the medication is safe and works well over a long period. Volunteers will take the study drug regularly and attend scheduled visits where doctors will check their health, record any side effects, and collect blood samples.

Key measurements include the level of a hormone called androstenedione, which helps assess how well the treatment is controlling the disease, as well as monitoring the need for other hormone replacements such as glucocorticoid therapy, often given as hydrocortisone. The study will also watch for signs of adrenal insufficiency, a condition where the body cannot produce enough stress hormones.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be required to provide signed informed consent. This consent confirms understanding and agreement to comply with the study's requirements and restrictions.

    Participants must have completed a previous study involving the medication CRN04894 and be assessed by the investigator as having an acceptable benefit-risk profile.

  2. Step 2

    Medication administration

    Participants will receive the medication CRN04894 in the form of a tablet. The medication is taken orally.

    The dosage will not exceed the maximum dose used in the previous study. The exact dosage and frequency will be determined by the study protocol and the investigator.

  3. Step 3

    Ongoing treatment

    Participants must maintain a stable regimen of glucocorticoid replacement therapy, such as hydrocortisone or its equivalents, as determined by the investigator.

    The minimum total daily dose of glucocorticoid must be equivalent to at least a specified amount of hydrocortisone.

  4. Step 4

    Safety and efficacy assessments

    The study will evaluate the safety and tolerability of CRN04894 by monitoring any adverse events or side effects that occur during the trial.

    Efficacy will be assessed by measuring changes in specific hormone levels, such as serum androstenedione, from the baseline over time.

  5. Step 5

    Completion of the study

    The study is expected to continue until November 30, 2027. Participants will be required to follow the study protocol until the end of the study or until they are advised otherwise by the investigator.

    Participants will be monitored for any changes in their condition and any necessary adjustments to their treatment will be made by the study team.

Who can join the trial?

6 criteria

  • Participants must have Congenital Adrenal Hyperplasia (CAH) and have completed a previous study with the study drug CRN04894, with a positive assessment from the study doctor.
  • Participants must be following a stable treatment plan with glucocorticoid replacement (a type of medication that replaces hormones) and taking a minimum daily dose of hydrocortisone or its equivalent.
  • Female participants who have heterosexual intercourse must either be unable to have children (due to surgery or menopause) or agree to use a highly effective method of birth control during the study and for at least 2 weeks after the last dose of the study drug.
  • Male participants must agree to use a condom during sexual activity with a female partner who can have children, or be surgically sterile, or agree to remain abstinent. They should also agree not to donate sperm during the study and for at least 2 weeks after the last dose of the study drug.
  • Participants must be willing and able to provide signed consent to participate in the study, understanding all the requirements and restrictions.
  • Participants must be willing and able to follow all study procedures and take the study treatment as directed.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health conditions that might affect their safety or the results of the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are unable to comply with the study procedures.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are taking medications that might interfere with the study drug.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients with a history of certain heart conditions.
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Investigated drugs

CRN04894 is a medication being studied to see how safe and effective it is for people who are taking it over a long period. The main goal of this study is to check if CRN04894 can help reduce levels of a hormone called androstenedione in the blood. Androstenedione is a hormone that can affect various body functions, and the study aims to see if CRN04894 can help manage its levels safely. Participants in the study will be monitored to ensure that the medication is safe to use and to see how well it works in achieving its intended effects.

What is already known about the treatment

CRN04894 – CRN04894 is a medication administered orally, meaning it is taken by mouth in the form of a pill or liquid. It is currently being studied in clinical trials to assess its safety and effectiveness, particularly for treating congenital adrenal hyperplasia, a condition affecting hormone production. The medication works by targeting specific molecules in the body to help regulate hormone levels, aiming to reduce the excess production of certain hormones. CRN04894 is classified as a therapeutic agent in the field of endocrinology, which deals with hormone-related conditions.

Investigated diseases

Congenital Adrenal Hyperplasia – Congenital Adrenal Hyperplasia is a group of genetic disorders affecting the adrenal glands, which are responsible for producing hormones like cortisol and aldosterone. In this condition, the adrenal glands produce an excess of androgen, a type of male sex hormone, and insufficient amounts of cortisol and sometimes aldosterone. This hormonal imbalance can lead to early signs of puberty in children and can affect growth and development. The condition is present from birth and can vary in severity. Over time, individuals may experience symptoms such as abnormal growth patterns, changes in skin pigmentation, and electrolyte imbalances. The progression of the disease can lead to complications if not managed properly.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514846-35-00Protocol codeCRN04894-09Estimated enrolment174 patientsSponsorCrinetics Pharmaceuticals Inc.

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