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

Stopped early · Phase 1

Conditions studied: Crohn Disease, Ulcerative Colitis

In brief

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 or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.

Key facts

Study ID

NCT03169894

Run by

Avalo Therapeutics, Inc.

People needed

8

Starts

2017-07-14

Expected to finish

2021-10-12

Last updated by the study team

2024-02-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is male or female, ≥ 18 to ≤ 75 years of age.
• Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation, or subject has received a diagnosis of UC for 90 days or greater prior to Visit 1, confirmed by endoscopy during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy.
• Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation, or subject has moderately to severely active UC, as defined by a Modified Mayo Score (excluding the PGA component) of 5 to 9 points at Visit 1.
• Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.

You may not qualify if…

• Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease 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.

Where it is running

• Sweet Hope Research Specialty, Inc. — Hialeah, Florida, United States
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• Egleston Hospital — Atlanta, Georgia, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Clinical Associates in Research Therapeutics of America, LLC — San Antonio, Texas, United States
• Care Access Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.