* Study of Lu AG13909 in Participants with Congenital Adrenal Hyperplasia
Research type
Research Study
Full title
A multi-site, open-label, sequential-group, multiple-ascending-dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of Lu AG13909 in patients with congenital adrenal hyperplasia.
IRAS ID
1005900
Contact name
Andrew Smith
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2022-000781-18
Research summary
This study will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. The main goals of this study are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909. Based on nonclinical data, Lu AG13909 is expected to reduce the abnormal androgen secretion from the adrenal glands, which is characteristic for CAH patients.
The study will include 2 parts:
• Part A is planned to include 3 to 6 participants for up to 3 dose levels
• Part B is planned to include 6 to 9 participants for 3 dose levels, depending on the number of patients included in Part A.
The planned maximum duration for each patient in this study will be 7.5 months. Each patient will be given 3 doses of Lu AG13909 over a period of 3 months – a dose every 4 to 5 weeks.
To take part in this study, patients must:
• Have a confirmed diagnosis of 21-hydroxylase deficiency CAH
• At the Screening Visit, have a blood concentration of 17-hydroxyprogesterone higher than 4 times the upper limit of normal in the morning before taking their cortisol replacement therapy
• Have been on a stable cortisol replacement therapy and mineralocorticoid replacement therapy (if needed) prior to the Screening Visit.
• Be between ≥18 and ≤55 years of age at the Screening Visit
• Have a BMI ≥ 18.5 (minimum 50 kg) and ≤ 35 kg/m2 at the Screening Visit and at the Baseline Visit
• Apart from CAH, be generally healthy in the opinion of the Investigator and based on medical history, physical examination, vital signs, ECGs and the results of the safety laboratory tests
Lu AG13909 is a monoclonal antibody against adrenocorticotropic hormone (ACTH), that is being developed by Lundbeck for conditions characterized by chronically and abnormally elevated ACTH, like Congenital Adrenal Hyperplasia (CAH).REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/FT/0097
Date of REC Opinion
18 Jul 2022
REC opinion
Further Information Favourable Opinion