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

Status:	Recruiting
Conditions:	Gastrointestinal, Crohns Disease
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 65
Updated:	3/10/2019
Start Date:	July 14, 2017
End Date:	July 2019

Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFα Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFα-Resistant Crohn's Disease [TRaCk LIGHT])

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.

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.

We found this trial at

sites

Hassman Research Institute

Berlin, New Jersey

Phone: 856-753-7335

from

Berlin, NJ