Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
36
Countries
2
Sites
4
Systemic Lupus Erythematosus
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 24 Nov 2025 → ongoing
- Decision date (initial)
- 2025-08-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
| 21.0 | LLT | 10040766 | Sjogren's disease | 10028395 |
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
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 9 | 2 |
| Netherlands | Authorised, recruiting | 9 | 2 |
| Rest of world
United Kingdom, United States
|
— | 18 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Service de Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Montpellier
Pôle Cancérologie, Médecine et Immunologie, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
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 | 2026-05-13 | ||||
| Netherlands | 2025-11-24 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-13 | Netherlands | Acceptable with conditions 2025-08-28
|
2025-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-30 | Netherlands | Acceptable 2025-12-09
|
2025-12-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-26 | Acceptable | 2026-04-28 |