Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
60
Countries
3
Sites
8
Lupus Nephritis
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 18 Dec 2025 → ongoing
- Decision date (initial)
- 2025-10-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518288-37-00
- ClinicalTrials.gov
- NCT06975787
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Lupus Nephritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025140 | Lupus nephritis | 100000004857 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Locations
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 6 | 1 |
| Germany | Ongoing, recruiting | 4 | 2 |
| Spain | Authorised, recruitment pending | 9 | 5 |
| Rest of world
Taiwan, Israel, United States, Korea, Republic of, Philippines
|
— | 41 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
250001: Nephrology, Place Amelie Raba Leon, 33000, Bordeaux
Universitaetsklinikum Regensburg AöR
276001: Abteilung für Nephrologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
276002: I.Medizinische Klinik und Poliklinik, Nephrologie, Langenbeckstrasse 1, Oberstadt, Mainz
Hospital Universitario Regional De Malaga
724004;Reumatología, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario 12 De Octubre
724005: Nefrología, Avenida De Cordoba Sn, 28041, Madrid
University Hospital Virgen Del Rocio S.L.
724002;Nefrología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Gregorio Maranon
724001;Nefrología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Clinica Universidad De Navarra
724003;Nefrología, Pio XII Etorbidea 36, 31008, Pamplona
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 | 2025-12-18 | 2025-12-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-19 | Spain | Acceptable 2025-10-03
|
2025-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-17 | Spain | Acceptable | 2025-10-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-21 | Spain | Acceptable 2026-04-27
|
2026-04-28 |