Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults with Severe Immunoglobulin E (IgE)-Mediated Food Allergy

2024-511032-27-00 Protocol R5458-668-ALG-2219 Human pharmacology (Phase I) - Other Ended

End 11 Aug 2025 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol R5458-668-ALG-2219

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

VersionLevelCodeTermSystem 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

CountryMS statusPlanned subjectsSites
Spain Ended 3 2
Rest of world
United States
6

Investigational sites

Spain

2 sites · Ended
Clinica Universidad De Navarra
Allergy and Immunology, Avenue Pio XII 36, 31008, Pamplona
Clinica Universidad De Navarra
Allergy and Immunology, Calle Marquesado De Santa Marta 1, 28027, Madrid

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision 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