Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
50
Countries
2
Sites
10
Crohn's Disease
Key facts
- Sponsor
- Exeliom Biosciences
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 20 Mar 2023 → 28 May 2024
- Decision date (initial)
- 2023-08-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502241-99-00
- EudraCT number
- 2021-003432-81
- ClinicalTrials.gov
- NCT05542355
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Crohn's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Exeliom Biosciences
- Sponsor organisation
- Exeliom Biosciences
- Address
- 67 Rue Des Godrans
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Exeliom Biosciences
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Exeliom Biosciences
- Contact name
- Clinical Trial Information Desk
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 6 | 2 |
| Poland | Ended | 44 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Imelda
Imeldaziekenhuis Bonheiden - Department of Gastroenterology, Imeldalaan 9, 2820, Bonheiden
CHU de Liege
Gastro-Endoscopie-Digestive, Domaine Universitaire du Sart-Tilman B35, 4000, Liege
Planetmed Sp. z o.o.
Gastroenterology, Ul. Lubinowa 12/8, 52-210, Wroclaw
Oddział Gastroenterologiczny SPZOZ w Łęczne
Gastroenterologii, ul. Krasnystawska 52, 21-010, Lcczna
WIP Warsaw IBD Point Profesor Kierkus
Gastroenterology, ul. Bobrowiecka 9b, 00-728, Warszawa
Endoskopia Sp. z o.o.
Gastroenterology, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Niepubliczny Zakład Opieki Zdrowotnej - Vivamed
Vivamed-Gastroenterology, ul. Zamiejska 17, 03-580, Warszawa
Centrum Medyczne "Medyk" Sp. zo.o. Sp.K
Gastroenterology, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Centrum Zdrowia MDM
Department of Hepatology - Gastroenterology, ul. Inflancka 4 A, 00-189, Warszawa
MEDRISE Sp. z o.o
Gastroenterology, ul. Onyksowa 10, ONYKSOWA Filia nr 2, Lublin
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 | 2023-08-21 | 2023-08-21 | 2024-05-28 | ||
| Poland | 2023-03-20 | 2023-03-20 | 2024-05-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-15 | Belgium | Acceptable 2023-07-20
|
2023-08-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-22 | Belgium | Acceptable 2023-11-17
|
2023-11-20 |