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

Crohn Disease Clinical Trial

Official title:
A Phase 1, Multicentre, 2-Part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants With Mild to Moderate Crohn's Disease

Clinical Trial Summary

A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to moderate Crohn's Disease (CD).

Clinical Trial Description

Initially, all participants will received standard of care (SoC) corticosteroid induction therapy for 3 to 7 weeks. Participants who meet the protocol defined criteria for response after corticosteroid therapy will enter a Maintenance Period. Participants not in clinical response/remission at the end of the Induction Period will discontinue the study without further study treatment. In the Maintenance Period, participants will receive oral EXL01 or placebo in combination with corticosteroid treatment (that is progressively tapered) and be monitored for safety and efficacy. The study will be conducted in 2 parts: - Part A: Participants eligible for maintenance treatment will receive open-label oral EXL01 for up to 24 weeks. - Part B: Participants eligible for maintenance treatment will be randomised 2:1 to receive double blind oral EXL01 or placebo for up to 24 weeks. Participants will be monitored for 30 days after end-of-treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05542355
Study type Interventional
Source Exeliom Biosciences
Contact Benjamin Hadida
Phone +33 6 72 43 72 94
Email bhadida@exeliombio.com
Status Recruiting
Phase Phase 1
Start date March 20, 2023
Completion date October 2025
View Details
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