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This trial 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 trial 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG13909 | Experimental | 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. After data from Part B has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part C will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule. Participants from Part C may be eligible to continue in the optional Treatment Extension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG13909 | Drug | Solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 161 | |
| Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs) | Day 1 up to Day 161 | |
| Parts A and B: Cmax: Maximum Observed Serum Concentration of Lu AG13909 | 0 (predose) up to 24 hours postdose on Day 1 to Day 161 | |
| Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax | 0 (predose) up to 24 hours postdose on Day 1 to Day 161 | |
| Parts A and B: Ctrough: Minimum Observed Serum Concentration of Lu AG13909 | 0 (predose) up to 24 hours postdose on Day 1 to Day 161 | |
| Parts A and B: t½: Apparent Elimination Half-life of Lu AG13909 | 0 (predose) up to 24 hours postdose on Day 1 to Day 161 | |
| Parts A and B: 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 | |
| Parts A and B: CL: Apparent Total Serum Clearance of Lu AG13909 | 0 (predose) up to 24 hours postdose on Day 1 to Day 161 | |
| Parts A and B: 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part C: Lu AG13909 Serum Concentrations Following Multiple IV Doses | Baseline up to Day 352 | |
| Part C: Change From Baseline of Lu AG13909 in Blood Concentrations of 17-OHP and A4 | Baseline up to Day 169 |
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Inclusion Criteria:
Parts A and B:
Part C:
Exclusion Criteria:
Part C Only:
Other inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Contact | +45 36301311 | HQ_Medinfo@Lundbeck.com |
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | HQ_Medinfo@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital-University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States | |
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| Parts A and B: 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 |
| Parts A and B: AUC0-tau: Area under the curve over a dosing interval | 0 (predose) up to 24 hours postdose on Day 1 to Day 161 |
| Part C: Morning Concentration of A4 in Blood <Upper Limit of Normal (ULN) | Day 169 |
| Part C: Number of Participants With TEAEs | Baseline up to Day 352 |
| Part C: Number of Participants With ADAs | Baseline up to Day 352 |
| Rigshospitalet |
| Recruiting |
| Copenhagen |
| 2100 |
| Denmark |
| Chu Angers | Recruiting | Angers | 49933 | France |
| CHU de Lille | Recruiting | Lille | 59000 | France |
| GH Pitié-Salpêtrière | Recruiting | Paris | 75013 | France |
| CHRU Strasbourg | Recruiting | Strasbourg | 67091 | France |
| David Metreveli Medical Centre, Tbilisi | Recruiting | Tbilisi | 0144 | Georgia |
| Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin | Recruiting | Dublin | D02 YN77 | Ireland |
| Azienda Ospedaliero Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma | Recruiting | Roma | 00161 | Italy |
| Centrum Nowoczesnych Terapii, Dobry Lekarz | Recruiting | Dobry Lekarz | 60-324 | Poland |
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 413 45 | Sweden |
| Karolinska University Hospital | Recruiting | Stockholm | 17174 | Sweden |
| NIHR/Wellcome Trust Clinical Research Facility | Recruiting | Birmingham | B15 2TH | United Kingdom |
| Cambridge Clinical Research Centre | Recruiting | Cambridge | CB2 0SL | United Kingdom |
| NIHR Clinical Research Facility | Recruiting | London | SE1 9RT | United Kingdom |
| University College London Hospital - NIHR | Recruiting | London | W1T 7HA | United Kingdom |
| ID | Term |
|---|---|
| D000312 | Adrenal Hyperplasia, Congenital |
| ID | Term |
|---|---|
| D047808 | Adrenogenital Syndrome |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D043202 | Steroid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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