8
Participants
Start Date
March 20, 2023
Primary Completion Date
October 2, 2024
Study Completion Date
October 2, 2024
EXL01
Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
Placebo
Oral EXL01 matching placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
SoC corticosteroid - Induction Period
Oral prednisone 40 mg or budesonide 9 mg once daily for 3 to 7 weeks, as assigned by the investigator
SoC corticosteroid - Tapering
"Same product as the Induction Period.~Oral prednisone: 30 mg for 1 week, 25 mg for 1 week, 20 mg for 1 week, 15 mg for 1 week, 10 mg for 1 week, 5 mg for 1 week and stop.~OR~Oral budesonide: 6 mg for 3 weeks, 3 mg for 3 weeks, stop."
CHU de Liege, Liège
Zespół Poradni Specjalistycznych REUMED, Lublin
"Centrum Medyczne Medyk Sp. zo.o. Sp.K", Rzeszów
Endoskopia Sp. z o. o., Ul. B.Chrobrego 6/8, Sopot
PlanetMed Sp.z.o.o. Gastroenterology, Ul.Lubinowa 12/8, Wroclaw
Lead Sponsor
Collaborators (1)
Alimentiv Inc.
OTHER
Exeliom Biosciences
INDUSTRY