Not recruitingRare disease

Study of Lu AG13909 in Adults with Cushing's Disease to Evaluate Safety and Effectiveness

Verified siteInvestigationalNo placebo

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What is this trial about?

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

The clinical trial investigates a new treatment for Cushing's disease, a rare condition where the body produces too much of a hormone called cortisol. The excess cortisol is caused by high levels of another hormone called adrenocorticotropic hormone (ACTH) that comes from the pituitary gland in the brain. This condition can lead to various health problems if left untreated.

The study will test a new medicine called Lu AG13909, which is a humanized antibody that targets ACTH. The medication will be given in two different ways: as an injection under the skin (subcutaneous use) and through a vein (intravenous use). The study aims to understand how well the medicine works in controlling cortisol levels and how safe it is for patients.

During the trial, participants will receive the study medication for up to 910 days. The researchers will monitor the amount of cortisol in participants' urine and how the medicine moves through the body. They will also track any side effects that may occur during the treatment period. This is a Phase II trial, which means the medication has already been tested for basic safety in humans, and now researchers are studying how well it works for treating Cushing's disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Treatment Phase
You will receive Lu AG13909 through an intravenous (IV) infusion (medicine given directly into a vein).
During this phase, doctors will monitor how your body processes the medication and its effects on cortisol levels (a hormone that is elevated in Cushing's disease).
Your treatment will be adjusted based on how your body responds to the medication.
Step 2
Transition to Injection Phase
After the initial phase, the treatment will change to subcutaneous injections (injections under the skin).
The medication will continue to be Lu AG13909, but delivered in a different way.
Regular monitoring will continue to ensure the treatment is working properly.
Step 3
Monitoring Period
Throughout the study, your hormone levels will be checked regularly through urine tests measuring urinary free cortisol (UFC).
Blood samples will be collected to measure the amount of medication in your system.
Regular health checks will include physical examinations, vital signs, and heart monitoring (ECG).
The total duration of participation may extend up to 1037 days (approximately 2.8 years).
Step 4
Safety Assessments
Any side effects or health changes will be recorded and monitored.
Laboratory tests will be performed regularly to check your overall health.
The effectiveness of the treatment will be measured by checking if your cortisol levels return to normal ranges.

Who can join the trial?

9 criteria

You must be an adult (18 years or older) diagnosed with Cushing's disease confirmed by a doctor
Your blood must show elevated levels of ACTH (a hormone that controls cortisol production) in morning measurements
You must have at least one of these conditions:
- A pituitary tumor larger than 6 millimeters shown on MRI scan
- Specific blood test results from the petrosal sinuses (blood vessels near the pituitary)
- Laboratory confirmation of an ACTH-producing tumor
- Your 24-hour urinary free cortisol (a test measuring cortisol in urine) must be at least 1.5 times higher than the normal upper limit, measured over 3 or more days
- You must be generally healthy except for Cushing's disease and related controlled conditions like diabetes or high blood pressure
- If you are currently taking medications for high cortisol levels, you must stop taking them for a specific period before starting the study tests
- Both men and women may participate in the study

Who cannot join the trial?

15 criteria

Age below 18 or above 65 years
Current pregnancy or breastfeeding
History of pituitary surgery (surgery on a small gland in the brain) within the last 3 months
History of radiation therapy to the pituitary area within the last 2 years
Severe or uncontrolled high blood pressure
Major surgery within the past 3 months
Significant heart, liver, or kidney disease
Active or chronic infections
History of blood clotting disorders
Use of medications that could interfere with the study drug
Mental health conditions that could affect participation
Active substance abuse or addiction
Participation in another clinical trial within the past 30 days
Known allergies to similar medications
Malignant tumors (cancer) in the past 5 years

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy
Semmelweis University
Responsive
Budapest, Hungary
Spitalul Clinic Judetean De Urgenta Cluj
Responsive
Cluj Napoca, Romania

Trial locations

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Investigated drugs

Based on the provided trial information, I can only identify: Lu AG13909 This is an investigational medication being studied for the treatment of Cushing's disease, a condition where the body produces too much cortisol hormone. The medication is being tested to see how it affects cortisol levels in adult patients, and to understand how the body processes the drug. The trial aims to determine if this medication is safe and well-tolerated by patients with Cushing's disease. Note: Since no other medications are mentioned in the source data, I cannot provide information about additional treatments involved in this trial.

Ag13909

What is already known about the treatment

Lu AG13909 - An investigational medication currently in Phase II clinical trials for the treatment of Cushing's Disease, a rare endocrine disorder characterized by excessive cortisol production. The drug is being studied to evaluate its ability to regulate and reduce cortisol levels in adult patients, though its exact mechanism of action is still under investigation through clinical research. This experimental compound is being assessed for safety, tolerability, and effectiveness, with researchers particularly focused on understanding how the body processes the medication (pharmacokinetics) and its potential therapeutic benefits in managing Cushing's Disease symptoms.

Investigated diseases

Cushing's Disease - A rare hormonal disorder that occurs when the body produces too much cortisol hormone over a long period. The condition begins when a tumor forms in the pituitary gland, causing it to release too much ACTH hormone, which in turn stimulates the adrenal glands to make excessive cortisol. This excess cortisol can lead to various physical changes, including weight gain in the face and trunk, thin arms and legs, easy bruising, and purple stretch marks on the skin. People with Cushing's Disease may also experience fatigue, muscle weakness, mood changes, and high blood pressure. The condition develops gradually, with symptoms appearing and progressing over time.