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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT03169894
• Date of registration: 24/05/2017
• Prospective Registration: Yes
• Primary sponsor: Aevi Genomic Medicine, LLC, a Cerecor company
• Public title: Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease
• Scientific title: 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-TNFa Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFa-Resistant Crohn's Disease [TRaCk LIGHT])
• Date of first enrolment: July 14, 2017
• Target sample size: 8
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03169894
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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-TNFa
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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: MDGN-002

Primary Outcome(s)

Incidence of Vital Signs Findings [Safety and Tolerability] [Time Frame: Through study completion, up to 12 weeks]

Incidence of Clinical Laboratory Tests Findings [Safety and Tolerability] [Time Frame: Through study completion, up to 12 weeks]

Incidence of Electrocardiogram (ECG) Findings [Safety and Tolerability] [Time Frame: Through study completion, up to 12 weeks]

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time Frame: Through study completion, up to 12 weeks]

Secondary Outcome(s)

Change from baseline in abdominal pain and loose/watery stool frequency [Time Frame: Baseline to 8 weeeks of treatment]

Change from baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD) [Time Frame: Baseline to 8 weeeks of treatment]

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). [Time Frame: Baseline to 8 weeeks of treatment]

MDGN-002 Plasma Concentration [Time Frame: Through study completion, up to 12 weeks]

Change from baseline in Crohn's Disease Activity Index (CDAI) [Time Frame: Baseline to 8 weeeks of treatment]

Secondary ID(s)

MDGN-002-CD-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors