EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease

PHASE1TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 20, 2023

Primary Completion Date

October 2, 2024

Study Completion Date

October 2, 2024

Conditions
Crohn Disease
Interventions
DRUG

EXL01

Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

DRUG

Placebo

Oral EXL01 matching placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

OTHER

SoC corticosteroid - Induction Period

Oral prednisone 40 mg or budesonide 9 mg once daily for 3 to 7 weeks, as assigned by the investigator

OTHER

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."

Trial Locations (5)

4000

CHU de Liege, Liège

20582

Zespół Poradni Specjalistycznych REUMED, Lublin

35-326

"Centrum Medyczne Medyk Sp. zo.o. Sp.K", Rzeszów

81-756

Endoskopia Sp. z o. o., Ul. B.Chrobrego 6/8, Sopot

52-210

PlanetMed Sp.z.o.o. Gastroenterology, Ul.Lubinowa 12/8, Wroclaw

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alimentiv Inc.

OTHER

lead

Exeliom Biosciences

INDUSTRY

NCT05542355 - EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease | Biotech Hunter | Biotech Hunter