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

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What is this study about?

This clinical trial is focused on studying a condition called , a genetic disorder affecting the adrenal glands, which are responsible for producing important hormones. The trial will evaluate a new treatment called , which is an . This means it works by blocking a specific receptor involved in hormone production. The study aims to assess the safety and effectiveness of in managing this condition.

Participants in the study will receive over a period of 12 weeks. The treatment will be given in a sequential dose manner, meaning the dose may be adjusted as the study progresses. The study will also involve monitoring the levels of certain hormones in the blood, such as androstenedione, to see how they change with the treatment. This will help determine how well the treatment is working.

In addition to , other medications may be used in the study, including , , , , and . These medications are commonly used to manage symptoms and hormone levels in people with . Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The study will help gather important information about the potential benefits and any side effects of for people with this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current treatment regimen.

Participants must have a stable glucocorticoid replacement regimen and meet other health requirements.

2 initial assessment

An initial assessment is conducted to establish baseline health metrics, including serum androstenedione (A4) levels.

This assessment helps in evaluating the effectiveness of the treatment over the course of the study.

3 treatment phase

Participants receive CRN04894 treatment orally for a duration of 12 weeks.

The treatment aims to evaluate safety, tolerability, and efficacy in managing congenital adrenal hyperplasia.

4 monitoring and follow-up

Regular monitoring is conducted to track any treatment-emergent adverse events (TEAEs) and changes in health status.

Participants’ serum A4 levels are measured before 11:00 AM at Week 12 to assess the primary efficacy endpoint.

5 final evaluation

At the end of the 12-week period, a final evaluation is performed to determine the overall impact of the treatment.

The study concludes with an analysis of the collected data to assess the primary and secondary endpoints.

Who Can Join the Study?

Participants must be male or female and between 18 to 75 years old. In the United States, participants can be as young as 16 years old.
Participants must have a condition called classic 21-hydroxylase deficiency, which needs to be confirmed by a doctor and approved by a medical expert.
Participants should be on a stable treatment plan for replacing certain hormones called glucocorticoids. This means no changes in the dose of more than 5 mg per day of a medicine like hydrocortisone in the last 6 months before the study starts.
Participants must follow their hormone replacement treatment plan as judged by the doctor during the Screening Period.
Participants need to take at least 15 mg of hydrocortisone (or an equivalent medicine) every day.
If participants are on estrogen therapy (a hormone treatment), the dose must not have changed for at least 3 months before the study starts.

Who Cannot Join the Study?

Individuals who are not diagnosed with Congenital Adrenal Hyperplasia. This is a condition present from birth that affects the adrenal glands, which are small glands located on top of each kidney.
Individuals who are not within the specified age range for the study.
Individuals who are not part of the specified clinical trial groups.
Individuals who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country	Status
Ludwig Maximilian University Of Munich	Munich	Germany
Uvbzzdbamz Dfxde Sluiy Do Ryea Le Skaktjno	Rome	Italy

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	29.09.2023
Italy	Not recruiting	29.09.2023

Trial locations

Investigated drugs:

CRN04894 is a medication being studied for its safety and effectiveness in treating individuals with Congenital Adrenal Hyperplasia. This trial aims to understand how well the medication works by observing changes in specific hormone levels in the blood. The study also focuses on ensuring that the medication is safe and well-tolerated by participants.

Congenital Adrenal Hyperplasia – This is a group of genetic disorders affecting the adrenal glands, which are responsible for producing certain hormones. In this condition, the adrenal glands produce an insufficient amount of cortisol and sometimes aldosterone, while producing an excess of androgen. This hormonal imbalance can lead to symptoms such as ambiguous genitalia in newborns, early onset of puberty, and rapid growth during childhood. Over time, individuals may experience issues with fertility, irregular menstrual cycles, and other hormone-related problems. The severity of symptoms can vary widely, depending on the specific genetic mutation and the level of enzyme deficiency.

Trial ID:

2023-503488-40-00

Protocol code:

CRN04894-03

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?