Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
57
Countries
7
Sites
13
Rheumatoid Arthritis
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
- 1 Oct 2025 → ongoing
- Decision date (initial)
- 2025-07-25
- 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
Rheumatoid Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 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
7 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Temporarily halted | 3 | 1 |
| France | Authorised, recruitment pending | 5 | 3 |
| Germany | Temporarily halted | 4 | 2 |
| Hungary | Temporarily halted | 6 | 2 |
| Netherlands | Authorised, recruitment pending | 8 | 1 |
| Romania | Temporarily halted | 10 | 2 |
| Spain | Temporarily halted | 4 | 2 |
| Rest of world
Argentina, United Kingdom, China
|
— | 17 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
1101: Department of Internal Diseases, Bulevard Bilgariya 104, 1404, Sofiya
Bicetre Hospital
2001:Rheumatology, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Regional Et Universitaire De Brest
2002:Rheumatology, Boulevard Tanguy Prigent, 29200, Brest
Assistance Publique Hopitaux De Paris
2003:Rheumatology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Universitaetsklinikum Jena KöR
1001:Klinik für Innere Medizin III, Rheumatologie/Osteologie, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
1002:I. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
50002:Phase I unit, Frankel Leo Ut 17-19, 1027, Budapest II
University Of Szeged
5001 : Phase I unit, Koranyi Fasor 6, 6720, Szeged
Centre for Human Drug Research
9001: Internal Medicine, Zernikedreef 8, 2333 CL, Leiden
Spitalul Clinic Judetean De Urgenta Cluj
6002: Rheumatology, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
6001: Internal Medicin, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Complexo Hospitalario Universitario De Santiago
8001:Rheumatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Vall D Hebron
8002:Rheumatology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2025-10-02 | 2025-10-02 | 2026-06-23 | ||
| Germany | 2025-10-01 | 2025-10-01 | 2026-06-23 | ||
| Hungary | 2026-06-16 | 2026-06-16 | 2026-06-23 | ||
| Romania | 2026-04-03 | 2026-04-03 | 2026-06-23 | ||
| Spain | 2025-10-06 | 2025-10-06 | 2026-06-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 5 · Art. 38 CTR
Temporary halt TH-140776
- Halt date
- 2026-06-23
- Member states concerned
- Bulgaria
- Publication date
- 2026-06-26
- 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-140777
- Halt date
- 2026-06-23
- Member states concerned
- Romania
- Publication date
- 2026-06-26
- 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-140774
- Halt date
- 2026-06-23
- Member states concerned
- Germany
- Publication date
- 2026-06-26
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Follow-up measures
- Please refer to the attached letter for a detailed description
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-140775
- Halt date
- 2026-06-23
- Member states concerned
- Hungary
- Publication date
- 2026-06-26
- 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-140778
- Halt date
- 2026-06-23
- Member states concerned
- Spain
- Publication date
- 2026-06-26
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Follow-up measures
- Please refer to the attached letter for a detailed description
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-27 | Germany | Acceptable 2025-07-21
|
2025-07-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-07 | Germany | Acceptable 2025-07-21
|
2025-08-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-10 | Germany | Acceptable 2026-01-19
|
2026-01-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-01 | Acceptable 2026-01-19
|
2026-04-01 |