Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
76
Countries
3
Sites
5
Light Chain Amyloidosis
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] - Neoplasms [C04]
- Trial duration
- 31 Jul 2024 → ongoing
- Decision date (initial)
- 2024-05-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Light Chain Amyloidosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10002022 | Amyloidosis | 100000004870 |
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 Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 6 | 2 |
| Greece | Ongoing, recruiting | 3 | 1 |
| Italy | Ongoing, recruiting | 7 | 2 |
| Rest of world
Australia, United States, Japan
|
— | 60 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Département de néphrologie et transplantation d'organes, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Service d'Hématologie Clinique et Thérapie Cellulaire, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Alexandra Hospital
Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
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 | 2024-07-31 | 2024-08-28 | |||
| Greece | 2024-08-02 | 2025-01-17 | |||
| Italy | 2024-10-30 | 2026-03-30 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | France | Acceptable 2024-05-06
|
2024-05-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-24 | France | Acceptable 2024-11-07
|
2024-11-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-07 | France | Acceptable 2025-05-12
|
2025-05-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-10 | France | Acceptable with conditions 2025-11-27
|
2025-11-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-18 | France | Acceptable 2026-02-04
|
2026-02-05 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-20 | France | Acceptable 2026-02-04
|
2026-05-20 |