Overview
Sponsor-declared trial summary
Healthy volunteers and patients with renal impairment; Intended indication: autoimmune diseases; systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), as well as dermatomyositis (DM) and polymyositis (PM).
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 4 Sep 2024 → 13 Apr 2026
- Decision date (initial)
- 2024-08-06
- 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
Healthy volunteers and patients with renal impairment; Intended indication: autoimmune diseases; systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), as well as dermatomyositis (DM) and polymyositis (PM).
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2024-09-04 | 2026-04-13 | 2024-09-24 | 2026-04-08 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-04 | Germany | Acceptable 2024-07-15
|
2024-08-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-21 | Germany | Acceptable 2024-11-12
|
2024-11-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-16 | Germany | Acceptable 2024-11-12
|
2025-01-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-14 | Germany | Acceptable 2025-11-17
|
2025-11-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-28 | Germany | Acceptable 2026-03-23
|
2026-03-23 |