Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
78
Countries
3
Sites
4
Rheumatoid Arthritis
Key facts
- Sponsor
- Aboleris Holdco
- Participant type
- Patients, Healthy volunteers
- 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 · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 10 | 1 |
| Germany | Authorised, recruiting | 8 | 2 |
| Netherlands | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Erlangen AöR
Department of Medicine 3 – Rheumatology and Immunology, Ulmenweg 18, Innenstadt, Erlangen
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
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
9 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 |