Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
134
Countries
2
Sites
7
Myelodysplastic Syndromes (MDS)
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 17 Feb 2017 → 15 Apr 2026
- Decision date (initial)
- 2023-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507154-32-00
- EudraCT number
- 2016-001657-41
- ClinicalTrials.gov
- NCT02942290
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myelodysplastic Syndromes (MDS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 5 | 2 |
| Germany | Ended | 17 | 5 |
| Rest of world
United States, United Kingdom, Canada, Australia
|
— | 112 | — |
Investigational sites
Hopital Saint Louis
Ile de France, 1 Avenue Claude Vellefaux, 75010, Paris
Hospital Hotel Dieu
Loire-Atlantique, 1 Place Alexis Ricordeau, 44000, Nantes
Universitaet Leipzig
Abteilung Haematologie und Internistische Onkologie, Johannisallee 32a, Zentrum-Südost, Leipzig
University Hospital Cologne AöR
Innere Medizin I Labor fuer molekulare Haematologie und Onkologie, Dr. Kreuzer LFI Gebaeude 13, Kerpener Strasse 62, Lindenthal, Cologne
Universitat Heidelberg
Medizinische Fakultaet Mannheim der Universitaet Heidelberg III. Medizinische Klinik,, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Martin-Luther-Universitaet Halle-Wittenberg
Klinik und Poliklinik für Innere Medizin IV Haematologie und Onkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
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 |
|---|---|---|---|---|---|
| France | 2018-04-17 | 2025-12-02 | 2018-07-17 | 2020-12-16 | |
| Germany | 2017-02-17 | 2026-01-08 | 2017-02-28 | 2020-12-18 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-17 | Germany | Acceptable 2023-11-23
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-10 | Germany | Acceptable 2024-08-23
|
2024-08-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-12 | Germany | Acceptable | 2024-11-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-03 | Germany | Acceptable 2025-05-28
|
2025-05-28 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-27 | Acceptable 2025-05-28
|
2025-10-27 |