Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.

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

Details

• Lead Sponsor: Aevi Genomic Medicine; Aevi Genomic Medicine, LLC, a Cerecor company
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

1. Subject is male or female, ≥ 18 to ≤ 75 years of age.

2. Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation.

3. Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation.

4. Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.

Exclusion Criteria:

1. Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

2. Subject with signs or symptoms of bowel obstruction.

3. Subject has short bowel syndrome.

4. Subject has a current functional colostomy or ileostomy.

5. Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period.

6. Subject is pregnant or a nursing mother.

7. Subject is sexually active and not using effective contraception as defined in the protocol.