Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease
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.
- Crohn Disease
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 1
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|MDGN-002 will be supplied in vials of 150 mg/mL. MDGN-002 will be administered by SQ injection in the abdomen every 14 days at 1 of 2 dose levels: 1.0 mg/kg or 3.0 mg/kg.||
- Aevi Genomic Medicine, LLC, a Cerecor company