A Phase 3, Multicenter, Open Label, Study to Evaluate the EFficacy and SaFEty of Leukotac® (Inolimomab) in Pediatric Patients With Steroid Resistant Acute Graft Versus Host Disease (SR-aGvHD) (EiFFEL)

NCT04289103 Phase 3 UNKNOWN

A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)

Details

Lead sponsor	ElsaLys Biotech
Phase	Phase 3
Status	UNKNOWN
Enrolment	65
Start date	2021-10
Completion	2024-06

Conditions

• Steroid Refractory GVHD

Interventions

• Inolimomab (Leukotac)

Primary outcomes

• Overall response — Day 29 post inclusion
  Complete response + very good partial response + partial response