Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
9
Countries
1
Sites
2
Severe IgE-mediated food allergy
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- completed 11 Aug 2025
- Decision date (initial)
- 2024-06-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511032-27-00
- ClinicalTrials.gov
- NCT06369467
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Severe IgE-mediated food allergy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10016946 | Food allergy | 100000004870 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 3 | 2 |
| Rest of world
United States
|
— | 6 | — |
Investigational sites
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-15 | Spain | Acceptable with conditions 2024-06-06
|
2024-06-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-26 | Spain | Acceptable with conditions | 2024-07-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-16 | Spain | Acceptable 2024-12-13
|
2024-12-13 |