Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
144
Countries
1
Sites
1
Atopic Dermatits
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-04-30
- 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
Atopic Dermatits
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 64 | 1 |
| Rest of world
United States
|
— | 80 | — |
Investigational sites
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-13 | Belgium | Acceptable with conditions 2026-04-30
|
2026-04-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-06 | Belgium | Acceptable with conditions 2026-04-30
|
2026-05-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-05-07 | Belgium | Acceptable 2026-05-21
|
2026-05-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-28 | Belgium | Acceptable 2026-05-21
|
2026-05-28 |