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

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Exeliom Biosciences
• Collaborator: Alimentiv Inc.

Criteria

Key Inclusion Criteria:

Must meet all of the following criteria at the start of the Induction Period:

• Male or female aged ≥18 years and <75 years at the time of providing informed consent.

• A diagnosis of CD with ileal involvement for at least 3 months prior to Screening.

• A CDAI score >180 and <350.

• Active mucosal inflammation.

Key Exclusion Criteria:

• Stricture with obstructive syndrome <3 months prior to Screening.

• Stenosis making endoscopic access to the terminal ileum difficult.

• Received treatment with high dose corticosteroid (≥40 mg prednisone daily) for >5 weeks within 3 months prior to Screening.

• Received ≥2 prior biologic treatments for CD including infliximab, ustekinumab, vedolizumab, adalimumab, and certolizumab.

• Major surgery or significant trauma ≤4 weeks prior to Screening.

• Small bowel resection >1 m in total or clinical manifestations of short bowel syndrome.

• Current stoma (ileostomy or a colostomy) or had a stoma in the last 6 months or any other intraabdominal surgery within 3 months prior to Screening.

• Started or stopped immunosuppressive therapy (thiopurine, methotrexate, tacrolimus, or other classical immunosuppressant) within 3 months prior to Screening.

• Received faecal microbial transplant within 3 months prior to Screening.

• Systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.

• Pregnant, breastfeeding, or expecting to conceive during the study.