RecruitingPHASE2INTERVENTIONAL

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

This research is an 'extension study' to learn more about a new medicine called atumelnant (also known as CRN04894) for people living with a condition called Congenital Adrenal Hyperplasia, or CAH. This medicine is being developed to help manage CAH. The main goal is to check how safe and effective atumelnant is over a longer period. Participants for this study are carefully chosen from those who have already taken part in a previous atumelnant study and, based on their experience, are thought to benefit from continuing the medication. Around 150 people are expected to join this study, which will help doctors understand its long-term impact.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Crinetics Pharmaceuticals Inc.

Enrolment target

150

Start

25 Feb 2025

Estimated completion

01 Nov 2027

Congenital Adrenal Hyperplasia Classic Congenital Adrenal Hyperplasia

What is this study about?

This study is an important next step for people living with Congenital Adrenal Hyperplasia (CAH). CAH is a group of inherited conditions where the adrenal glands, which are located on top of your kidneys, don't work properly to make certain hormones. This can lead to various health problems. Doctors are investigating a new medication called atumelnant (you might also see it referred to as CRN04894) to see if it can help manage CAH.

The main aim of this particular study is to understand how safe and effective atumelnant is when taken over a longer period. It's called an 'extension study' because it builds on earlier research. People who join this study will have already taken atumelnant as part of a previous study. The researchers want to see if continuing this treatment is beneficial and doesn't cause any unexpected problems over time. Think of it like a follow-up to make sure the medicine continues to work well and is well-tolerated.

About 150 people will take part in this research. By carefully monitoring these participants, doctors hope to gather valuable information that will help in developing atumelnant as a potential new treatment option for CAH. This kind of long-term study is crucial for thoroughly understanding a new medicine before it can be made widely available.

Key takeaways

Looks at the long-term safety and effectiveness of atumelnant for CAH.
Only for people who have already completed a previous atumelnant study.
Around 150 participants expected.
Requires stable existing CAH medication.
Careful monitoring of health and potential side effects.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To be able to join this study, you must have already taken part in a previous study involving the medicine CRN04894 (atumelnant) and completed your treatment in that earlier study. The doctors involved also need to believe that continuing to take this medicine would be helpful for you, based on how you responded in the first study.

You also need to be consistently taking your regular steroid medication (like hydrocortisone or prednisolone) to manage your CAH, and you must be taking a stable daily dose of hydrocortisone or an equivalent steroid when you agree to join the study.

For women who could become pregnant, you must either have had specific surgeries (like a hysterectomy or 'tubes tied'), or be past menopause for at least a year. If it's less than a year since your last period, blood tests will be needed to confirm menopause. Otherwise, you must agree to use highly effective contraception from before the study starts until at least two weeks after your last dose of the study medicine. Men must also agree to use a condom if they are sexually active with a female partner who could become pregnant, from the start of the study until at least two weeks after their last dose.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you taken part in a previous atumelnant (CRN04894) study and completed it?
Are you currently on a stable dose of your regular steroid medication for CAH?
If you are a woman and could become pregnant, are you using highly effective contraception, or are you postmenopausal/surgically sterile?
If you are a man, are you willing to use a condom if sexually active with a female partner who could become pregnant?

Answer every question to see your result.

What does participation involve?

If you are invited to participate, you will receive the study medicine, atumelnant (CRN04894), on an ongoing basis. This is an 'open-label' study, meaning both you and the study doctors will know you are receiving atumelnant. The study will involve regular check-ups, which will include physical examinations, blood tests, and other assessments to monitor your health, how the medicine is affecting your CAH, and to check for any side effects. The exact number and timing of visits will be explained by the study team. You will continue to take your regular steroid medication for CAH alongside the study drug. The total duration of your participation in this study will depend on how the study progresses and how you respond to the treatment.

Potential risks and benefits

Participating in this study might offer potential benefits, such as continued access to a new medication that could help manage your Congenital Adrenal Hyperplasia. However, like all medicines, atumelnant may have side effects, some of which may be currently unknown or only become apparent with longer-term use. The study team will closely monitor your health to identify any potential risks. You will be fully informed about all known risks and benefits before deciding to take part, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Crinetics Study Site, Minneapolis, Minnesota 55454
Verified postcode
Minneapolis, United States· Active not recruiting
Crinetics Study Site
Verified postcode
Morehead City, United States· Active not recruiting
Crinetics Study Site
Verified postcode
Córdoba, Argentina· Recruiting
Crinetics Study Site
Verified postcode
Botucatu, Brazil· Recruiting
Crinetics Study Site
Verified postcode
São Paulo, Brazil· Recruiting
Crinetics Study Site
Verified postcode
Munich, Germany· Recruiting
Crinetics Study Site
Verified postcode
Roma, Italy· Recruiting
Crinetics Study Site
Verified postcode
Birmingham, United Kingdom· Recruiting
Crinetics Study Site
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Congenital Adrenal Hyperplasia (CAH)?

CAH is a group of inherited conditions where the adrenal glands (small glands above your kidneys) don't make enough of certain important hormones.

What is atumelnant (CRN04894)?

Atumelnant is a new medicine being investigated to help manage Congenital Adrenal Hyperplasia. This study is looking at its long-term effects.

Why is this study only for people who were in a previous study?

This is an 'extension study,' designed to follow up on people who have already taken atumelnant in an earlier study to see its long-term safety and effectiveness.

Will I know if I'm getting the active medicine?

Yes, this is an 'open-label' study, meaning everyone, including you and your doctors, will know you are receiving atumelnant.

Can I stop participating in the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

How to find out more

Crinetics Clinical Trials Crinetics Clinical Trials

clinicaltrials@crinetics.com 833-827-9741 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.