Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
2
Sites
12
ULCERATIVE COLITIS
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 30 May 2023 → 11 Nov 2025
- Decision date (initial)
- 2023-03-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501047-32-00
- ClinicalTrials.gov
- NCT05549323
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
ULCERATIVE COLITIS
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
2 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 16 | 1 |
| Poland | Ended | 19 | 11 |
| Rest of world
United States
|
— | 13 | — |
Investigational sites
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Zakład Endoskopii NSSU, Ul. Macieja Jakubowskiego 2, 30-688, Krakow
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
-, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Klimed MK Sp. z o.o.
-, Aleja Jana Pawla II 59/6u, 15-704, Bialystok
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
-, Ul. Polskiej Organizacji Wojskowej 12 C, 97-300, Piotrkow Trybunalski
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Gastroenterologii i Chorob Wewnetrznych, Ulica Szaserow 128, 04-141, Warsaw
Med Sp. z o.o.
-, Ul. Polnej Rozy 6/u2, 02-798, Warsaw
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
Ul. Elizy Orzeszkowej 13, Ul. Elizy Orzeszkowej 13, 82-300, Elblag
Centrum Medyczne Med-Gastr Sp. z o.o.
-, Ul. Mokra 4, 91-034, Lodz
Mz Badania Slowik Zymla Sp. j.
-, Ul. Ks. Alojzego Kozielka 8, 44-190, Knurow
H-T.Centrum Medyczne Sp. z o.o. sp.k.
-, Aleja Bielska 105, 43-100, Tychy
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 |
|---|---|---|---|---|---|
| Germany | 2023-07-04 | 2025-10-24 | 2023-08-08 | 2025-09-15 | |
| Poland | 2023-05-30 | 2025-11-05 | 2023-06-20 | 2025-09-15 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-15 | Germany | Acceptable 2023-03-13
|
2023-03-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-03-23 | Germany | Acceptable 2023-03-13
|
2023-03-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-04-04 | Acceptable | 2023-05-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-04-12 | Germany | Acceptable | 2023-05-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-07-05 | Germany | Acceptable | 2023-07-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-08-18 | Germany | Acceptable 2023-10-19
|
2023-10-23 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-11-27 | Acceptable 2023-10-19
|
2023-11-27 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-04-15 | Germany | Acceptable 2023-10-19
|
2024-04-15 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-04-26 | Acceptable | 2024-06-14 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-15 | Germany | Acceptable 2024-10-09
|
2024-10-10 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-10-17 | Germany | Acceptable 2024-10-09
|
2024-10-17 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-10-29 | Germany | Acceptable 2024-10-09
|
2024-10-29 |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-04 | Germany | Acceptable 2025-04-16
|
2025-04-22 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-10-08 | Germany | Acceptable 2025-04-16
|
2025-10-08 |