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

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    8
  • sponsor
    Aevi Genomic Medicine, LLC, a Cerecor company
Updated on 13 July 2021
Investigator
Christine Arel
Primary Contact
Advanced Research Institute, Inc. (4.5 mi away) Contact
+11 other location
monoclonal antibodies
endoscopy
tumor necrosis factor
crohn's disease
tumor necrosis factor alpha
tumour necrosis

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-TNF) treatment.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment MDGN-002
Clinical Study IdentifierNCT03169894
SponsorAevi Genomic Medicine, LLC, a Cerecor company
Last Modified on13 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is male or female, 18 to 75 years of age
Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation
Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of 7, and histological confirmation
Subject has failed treatment with an approved therapeutic dose of an anti-TNF monoclonal antibody treatment

Exclusion Criteria

Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis
Subject with signs or symptoms of bowel obstruction
Subject has short bowel syndrome
Subject has a current functional colostomy or ileostomy
Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period
Subject is pregnant or a nursing mother
Subject is sexually active and not using effective contraception as defined in the protocol
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