Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
78
Countries
3
Sites
5
Rheumatoid Arthritis
Key facts
- Sponsor
- Aboleris Holdco
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 31 Jan 2025 → ongoing
- Decision date (initial)
- 2025-08-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rheumatoid Arthritis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aboleris Holdco
- Sponsor organisation
- Aboleris Holdco
- Address
- Rue Antoine De Saint-Exupery 14
- City
- Charleroi
- Postcode
- 6041
- Country
- Belgium
Scientific contact point
- Organisation
- Aboleris Holdco
- Contact name
- Director Clinical Operations
Public contact point
- Organisation
- Aboleris Holdco
- Contact name
- Director Clinical Operations
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 10 | 2 |
| Germany | Authorised, recruiting | 8 | 2 |
| Netherlands | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre hospitalier universitaire de Liege
rheumatology, Avenue De L'Hopital 1, 4000, Liege
SGS Belgium
Clinical Pharmacology Unit, Drie Eikenstraat 655, 2650, Edegem
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Universitaetsklinikum Erlangen AöR
Department of Medicine 3 – Rheumatology and Immunology, Ulmenweg 18, Innenstadt, Erlangen
Centre for Human Drug Research
Immunology, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Belgium | 2025-11-04 | 2026-02-13 | |||
| Germany | 2026-04-01 | ||||
| Netherlands | 2025-01-31 | 2025-02-10 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-16 | Netherlands | Acceptable 2025-01-31
|
2025-01-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-30 | Netherlands | Acceptable 2025-05-15
|
2025-05-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-20 | Netherlands | Acceptable 2025-05-15
|
2025-05-20 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-06-12 | Acceptable 2025-05-15
|
2025-08-14 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-04 | Netherlands | Acceptable 2025-05-15
|
2025-09-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-24 | Netherlands | Acceptable 2025-05-15
|
2025-11-24 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-16 | Netherlands | Acceptable 2025-05-15
|
2025-12-16 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-12-18 | Netherlands | Acceptable 2025-05-15
|
2025-12-18 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-12-19 | Acceptable 2025-05-15
|
2026-03-10 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-30 | Netherlands | Acceptable 2026-06-11
|
2026-06-11 |