Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
43
Countries
6
Sites
16
Congenital adrenal hyperplasia
Key facts
- Sponsor
- H. Lundbeck A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 25 Jan 2024 → ongoing
- Decision date (initial)
- 2023-05-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503711-15-00
- EudraCT number
- 2022-000781-18
- ClinicalTrials.gov
- NCT05669950
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Congenital adrenal hyperplasia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10010323 | Congenital adrenal hyperplasia | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
H. Lundbeck A/S
- Sponsor organisation
- H. Lundbeck A/S
- Address
- Ottiliavej 9
- City
- Valby
- Postcode
- 2500
- Country
- Denmark
Scientific contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- Clinical Trial Information
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 2 | 2 |
| France | Ongoing, recruitment ended | 4 | 4 |
| Ireland | Ongoing, recruitment ended | 1 | 1 |
| Italy | Ongoing, recruitment ended | 7 | 6 |
| Poland | Ongoing, recruitment ended | 1 | 1 |
| Sweden | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
United States, United Kingdom, Georgia
|
— | 22 | — |
Investigational sites
Steno Trials; Steno Diabetes Center Aarhus
Endocrinology, Palle Juul-Jensens Boulevard 11, Entrance A, Aarhus N
Copenhagen University Hospital
Department of Nephrology and Endocrinology 2132, Blegdamsvej 9, 2100, Copenhagen Oe
Assistance Publique Hopitaux De Paris
Endocrinology and reproductive medicine, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier Universitaire De Lille
Endocrinologie, Diabétologie, Oncologie endocrinienne, Métabolism, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire D'Angers
CHU Angers - Départment d´Endocrinologie - Diabétologie et Nutrition, 4 Rue Larrey, 49100, Angers
Les Hopitaux Universitaires De Strasbourg
Service Endocrinologie, Diabéte et Nutrition, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Bambino Gesu Childrens Hospital
Endocrinology and Diabetology Unit, Piazza Sant'onofrio 4, 00165, Rome
Azienda Ospedaliera di Padova
DIDAS Medicina dei sistemi, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department of Medical and Surgical Sciences (DIMEC), Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department of Experimental Medicine, Sapienza University of Rome, Viale Del Policlinico 155, 00161, Rome
Ospedale San Raffaele S.r.l.
Department of Pediatrics, Via Olgettina 60, 20132, Milan
ASST Papa Giovanni XXIII
Malattie Endocrine - Diabetologia, Piazza Oms, 1, Bergamo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-01-26 | 2026-01-26 | 2026-03-02 | ||
| France | 2025-12-17 | 2025-12-17 | 2026-03-02 | ||
| Ireland | 2025-12-15 | 2025-12-15 | 2026-03-02 | ||
| Italy | 2025-12-17 | 2025-12-17 | 2026-03-02 | ||
| Poland | 2026-01-31 | 2026-01-31 | 2026-03-02 | ||
| Sweden | 2024-01-25 | 2024-01-25 | 2026-03-02 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-12 | Denmark | Acceptable 2023-05-02
|
2023-05-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-06 | Denmark | Acceptable 2023-07-14
|
2023-07-17 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-07-27 | Acceptable 2023-05-02
|
2023-10-18 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2023-07-27 | Acceptable 2023-05-02
|
2023-10-10 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-20 | Acceptable 2023-05-02
|
2023-10-20 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-07 | Denmark | Acceptable 2024-01-11
|
2024-01-19 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-22 | Denmark | Acceptable 2024-07-08
|
2024-07-08 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-22 | Denmark | Acceptable 2025-04-24
|
2025-04-25 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-05-19 | Acceptable 2025-04-24
|
2025-08-13 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-05-19 | 2025-08-18 | ||
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-05-20 | Acceptable 2025-04-24
|
2025-08-15 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-21 | Acceptable | 2025-06-27 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-29 | Acceptable | 2025-07-23 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-09 | Denmark | Acceptable | 2025-10-02 |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-16 | Denmark | Acceptable 2025-12-09
|
2025-12-10 |