search
Back to results

Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Primary Purpose

Congenital Adrenal Hyperplasia

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Lu AG13909
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Adrenal Hyperplasia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University College London Hospital NHS Foundation TrustRecruiting
  • Guy's and St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lu AG13909

Arm Description

Participants in Part A will receive multiple intravenous (IV) doses of Lu AG13909 per a prespecified dosing schedule. After data from Part A has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part B will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of Participants With Anti-Drug Antibodies (ADAs)
Cmax: Maximum Observed Serum Concentration of Lu AG13909
Tmax: Nominal Time Corresponding to the Occurrence of Cmax
Ctrough: Minimum Observed Serum Concentration of Lu AG13909
t½: Apparent Elimination Half-life of Lu AG13909
AUC0-infinity: Area under the plasma concentration curve of x from zero to infinity of Lu AG13909
CL: Apparent Total Serum Clearance of Lu AG13909
Vz: Volume of Distribution During the Terminal Elimination Phase After IV Administration of Lu AG13909
Change From Baseline After Each Dose of Lu AG13909 in Blood Concentrations of 17-hydroxyprogesterone (17-OHP) and Androstenedione (A4)
AUC0-tau: Area under the curve over a dosing interval

Secondary Outcome Measures

Full Information

First Posted
December 20, 2022
Last Updated
June 13, 2023
Sponsor
H. Lundbeck A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT05669950
Brief Title
Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
December 28, 2024 (Anticipated)
Study Completion Date
December 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Adrenal Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lu AG13909
Arm Type
Experimental
Arm Description
Participants in Part A will receive multiple intravenous (IV) doses of Lu AG13909 per a prespecified dosing schedule. After data from Part A has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part B will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule.
Intervention Type
Drug
Intervention Name(s)
Lu AG13909
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to Day 161
Title
Number of Participants With Anti-Drug Antibodies (ADAs)
Time Frame
Day 1 up to end of study (Day 161)
Title
Cmax: Maximum Observed Serum Concentration of Lu AG13909
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161
Title
Tmax: Nominal Time Corresponding to the Occurrence of Cmax
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161
Title
Ctrough: Minimum Observed Serum Concentration of Lu AG13909
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161
Title
t½: Apparent Elimination Half-life of Lu AG13909
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161
Title
AUC0-infinity: Area under the plasma concentration curve of x from zero to infinity of Lu AG13909
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161
Title
CL: Apparent Total Serum Clearance of Lu AG13909
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161
Title
Vz: Volume of Distribution During the Terminal Elimination Phase After IV Administration of Lu AG13909
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161
Title
Change From Baseline After Each Dose of Lu AG13909 in Blood Concentrations of 17-hydroxyprogesterone (17-OHP) and Androstenedione (A4)
Time Frame
Baseline up to Day 85
Title
AUC0-tau: Area under the curve over a dosing interval
Time Frame
0 (predose) up to 24 hours postdose on Day 1 to Day 161

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Email contact via H. Lundbeck A/S
Phone
+45 36301311
Email
LundbeckClinicalTrials@Lundbeck.com
Facility Information:
Facility Name
University College London Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

We'll reach out to this number within 24 hrs