NCT05542355

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Exeliom Biosciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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. Due to the low recruitment rate into Part A, the study was discontinued early; Part B did not start.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-20
• Primary completion: 2024-10-02
• Completion: 2024-10-02
• First posted: 2022-09-15
• Last updated: 2024-10-10

Locations

5 sites across 2 countries: Belgium, Poland