Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669950
• Other study ID #: 19873A
• Status: Recruiting
• Phase: Phase 1
• Start date: December 19, 2022
• Est. completion date: December 28, 2024

Study information

• Verified date: June 2023
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).
• Morning (pre-glucocorticoid [GC] replacement dose) blood concentrations of 17-OHP >4-times upper limit of normal (ULN).
• Body mass index (BMI) =18.5 kilograms (kg)/square meter (m^2) (minimum 50 kg) and =35 kg/m^2.
• Stable GC replacement therapy for =1 month prior to the Screening Visit.
• For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for =3 months prior to the Screening Visit.
• Apart from CAH, the participant is 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.

Exclusion Criteria:

• The participant is pregnant or breastfeeding.
• The participant has a clinically significant abnormal laboratory value, electrocardiogram (ECG) parameter, or vital signs value, or other safety findings at the Screening Visit that indicate a potential risk for the participant if enrolled, in the opinion of the investigator.
• The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients. Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• Congenital Adrenal Hyperplasia
• Hyperplasia

Intervention

Drug:
• Lu AG13909
Solution for infusion

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	University College London Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)		Up to Day 161
Primary	Number of Participants With Anti-Drug Antibodies (ADAs)		Day 1 up to end of study (Day 161)
Primary	Cmax: Maximum Observed Serum Concentration of Lu AG13909		0 (predose) up to 24 hours postdose on Day 1 to Day 161
Primary	Tmax: Nominal Time Corresponding to the Occurrence of Cmax		0 (predose) up to 24 hours postdose on Day 1 to Day 161
Primary	Ctrough: Minimum Observed Serum Concentration of Lu AG13909		0 (predose) up to 24 hours postdose on Day 1 to Day 161
Primary	t½: Apparent Elimination Half-life of Lu AG13909		0 (predose) up to 24 hours postdose on Day 1 to Day 161
Primary	AUC0-infinity: Area under the plasma concentration curve of x from zero to infinity of Lu AG13909		0 (predose) up to 24 hours postdose on Day 1 to Day 161
Primary	CL: Apparent Total Serum Clearance of Lu AG13909		0 (predose) up to 24 hours postdose on Day 1 to Day 161
Primary	Vz: Volume of Distribution During the Terminal Elimination Phase After IV Administration of Lu AG13909		0 (predose) up to 24 hours postdose on Day 1 to Day 161
Primary	Change From Baseline After Each Dose of Lu AG13909 in Blood Concentrations of 17-hydroxyprogesterone (17-OHP) and Androstenedione (A4)		Baseline up to Day 85
Primary	AUC0-tau: Area under the curve over a dosing interval		0 (predose) up to 24 hours postdose on Day 1 to Day 161