New therapeutic approach to Toxic Epidermal Necrolysis (TEN) using anti-CD38+ antibodies in the active phase of the disease – Phase I/II study to assess the tolerance and efficacy of DARATUMUMAB - NET-CD38 Study

2024-512164-63-00 Protocol 69HCL23_1000 Phase I and Phase II (Integrated) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol 69HCL23_1000

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Authorised, recruitment pending
Participants planned 9
Countries 1
Sites 2

Toxic Epidermal Necrolysis

Key facts

Sponsor
Hospices Civils De Lyon
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Skin and Connective Tissue Diseases [C17]
Decision date (initial)
2025-04-29
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Toxic Epidermal Necrolysis

VersionLevelCodeTermSystem organ class
20.0 LLT 10028849 Necrolysis epidermal toxic (Lyell type) 10040785
20.0 LLT 10042032 Stevens Jonhson syndrome 10040785

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

39 Total trials 20 Recruiting 11 Ended
Commercial
Sponsor organisation
Hospices Civils De Lyon
Address
3 Quai Des Celestins, Bp 2251 Bp 2251
City
Lyon Cedex 02
Postcode
69229
Country
France

Scientific contact point

Organisation
Hospices Civils De Lyon
Contact name
Dr Benoit BEN SAID

Public contact point

Organisation
Hospices Civils De Lyon
Contact name
Dr Benoit BEN SAID

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 9 2
Rest of world — 0 —

Investigational sites

France

2 sites · Authorised, recruitment pending
Hospices Civils De Lyon
Centre de référence sur les dermatoses bulleuses toxiques et les toxidermies sévères, 5 Place D Arsonval, 69437, Lyon Cedex 03
Hospices Civils De Lyon
Allergy and Clilinical Immunology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-02-04 France Acceptable
2025-04-16
 2025-04-29