Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
46
Countries
4
Sites
11
Systemic Lupus Erythematosus (SLE) With or Without Active Lupus Nephritis (LN)
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus (SLE) With or Without Active Lupus Nephritis (LN)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 4 | 3 |
| Germany | Authorised, recruitment pending | 3 | 2 |
| Italy | Authorised, recruitment pending | 6 | 3 |
| Spain | Authorised, recruitment pending | 4 | 3 |
| Rest of world
Argentina, Brazil, Australia, China
|
— | 29 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Néphrologie et transplantation d'organes, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Hospices Civils De Lyon
Médecine interne, 5 Place D Arsonval, 69437, Lyon Cedex 03
Centre Hospitalier Universitaire De Poitiers
Néphrologie, hémodialyse et transplantation rénale, 2 Rue De La Miletrie, 86000, Poitiers
LMU Klinikum Muenchen AöR
NA, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
NA, Langenbeckstrasse 1, Oberstadt, Mainz
Humanitas Mirasole S.p.A.
Rheumatology and Clinical immunology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UO Nephrology, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Rheumatology, Largo Francesco Vito 1, 00168, Rome
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-17 | Spain | Acceptable 2026-04-20
|
2026-04-22 |