Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
44
Countries
5
Sites
10
Systemic Lupus Erythematosus
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 8 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510025-14-00
- ClinicalTrials.gov
- NCT06335979
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 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
5 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 3 | 1 |
| Germany | Temporarily halted | 16 | 3 |
| Hungary | Temporarily halted | 4 | 2 |
| Netherlands | Temporarily halted | 4 | 1 |
| Spain | Temporarily halted | 5 | 3 |
| Rest of world
United States, China, Switzerland
|
— | 12 | — |
Investigational sites
Universitaetsklinikum Essen AöR
1014:Klinik für Nephrologie und Infektiologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
1002: I. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Charite Research Organisation GmbH
1001, Chariteplatz 1, Mitte, Berlin
University Of Szeged
1010: Szent-Györgyi Albert Klinikai Központ, Klinikai Farmakológiai Központ, Fázis I. vizsgálóhely, Koranyi Fasor 6, 6720, Szeged
Semmelweis University
1011: Belgyógyászati és Onkológiai Klinika, Klinikai Farmakológiai részleg, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Centre for Human Drug Research
#1003: Internal Medicine, Zernikedreef 8, 2333 CL, Leiden
Hospital Universitari Vall D Hebron
#1005: Rheumatology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
#1013; Rheumatology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Complexo Hospitalario Universitario De Santiago
#1006: Rheumatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-11-07 | 2024-11-25 | 2024-11-07 | 2024-11-07 | |
| Germany | 2024-10-08 | 2024-10-08 | 2026-06-09 | ||
| Hungary | 2026-04-21 | 2026-04-21 | 2026-06-09 | ||
| Netherlands | 2025-02-20 | 2025-02-20 | 2026-06-09 | ||
| Spain | 2024-10-31 | 2024-10-31 | 2026-06-09 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-138602
- Halt date
- 2026-06-09
- Member states concerned
- Germany
- Publication date
- 2026-06-12
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Follow-up measures
- Please refer to the attached letter for a detailed description.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-138601
- Halt date
- 2026-06-09
- Member states concerned
- Spain
- Publication date
- 2026-06-12
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Follow-up measures
- Please refer to the attached letter for a detailed description.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-138600
- Halt date
- 2026-06-09
- Member states concerned
- Netherlands
- Publication date
- 2026-06-12
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Follow-up measures
- Please refer to the attached letter for a detailed description.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-138599
- Halt date
- 2026-06-09
- Member states concerned
- Hungary
- Publication date
- 2026-06-12
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Follow-up measures
- Please refer to the attached letter for a detailed description.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Germany | Acceptable 2024-09-09
|
2024-09-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-19 | Acceptable 2024-09-09
|
2024-09-19 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-26 | Acceptable 2024-09-09
|
2024-09-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-11 | Acceptable | 2024-10-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-17 | Germany | Acceptable | 2024-11-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-08 | Germany | Acceptable 2025-03-10
|
2025-03-10 |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-06-04 | 2025-08-22 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-10 | Germany | Acceptable 2025-11-03
|
2025-11-05 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-12 | Germany | Acceptable 2026-04-14
|
2026-04-15 |