Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
8
Countries
1
Sites
1
immune-mediated inflammatory disorders, including ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 18 Dec 2023 → 2 Mar 2024
- Decision date (initial)
- 2023-10-26
- 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
immune-mediated inflammatory disorders, including ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
| 20.0 | PT | 10001761 | Alopecia areata | 100000004858 |
| 20.1 | PT | 10064212 | Eosinophilic oesophagitis | 100000004856 |
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2023-12-18 | 2024-03-01 | 2023-12-20 | 2024-01-17 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-18 | Belgium | Acceptable 2023-10-25
|
2023-10-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-15 | Belgium | Acceptable 2023-12-05
|
2023-12-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-04 | Belgium | Acceptable 2023-12-05
|
2024-01-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-20 | Belgium | Acceptable 2024-03-26
|
2024-03-27 |