Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
32
Countries
1
Sites
3
Lupus Nephritis
Key facts
- Sponsor
- Kyverna Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 20 Jul 2023 → 22 Dec 2025
- Decision date (initial)
- 2024-06-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513329-22-00
- EudraCT number
- 2022-003686-38
- ClinicalTrials.gov
- NCT05938725
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
Kyverna Therapeutics Inc.
- Sponsor organisation
- Kyverna Therapeutics Inc.
- Address
- 5980 Horton Street Ste 550
- City
- Emeryville
- Postcode
- 94608-2045
- Country
- United States
Scientific contact point
- Organisation
- Kyverna Therapeutics Inc.
- Contact name
- Medical Kyverna
Public contact point
- Organisation
- Kyverna Therapeutics Inc.
- Contact name
- Medical Kyverna
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 32 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Leipzig AöR
Clinic and Polyclinic for Endocrinology, Nephrology, Rheumatology Rheumatology, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Duesseldorf AöR
Clinic for Rheumatology, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Erlangen AöR
Medical Clinic 3 - Rheumatology and Immunology, Ulmenweg 18, Innenstadt, Erlangen
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 | 2023-07-20 | 2025-12-22 | 2023-09-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-07 | Germany | Acceptable 2024-06-26
|
2024-06-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-15 | Germany | Acceptable 2025-01-09
|
2025-01-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-21 | Germany | Acceptable | 2025-04-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-05 | Germany | Acceptable | 2025-12-02 |