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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03169894
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Aevi Genomic Medicine

Brief 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-TNFα) treatment.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: MDGN-002 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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-TNFα Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFα-Resistant Crohn's Disease [TRaCk LIGHT])
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: MDGN-002
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.
Drug: MDGN-002
MDGN-002 is a fully human IgG4 monoclonal antibody specific to human LIGHT.
Other Name: AEVI-002




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Through study completion, up to 12 weeks ]
  2. Incidence of Vital Signs Findings [Safety and Tolerability] [ Time Frame: Through study completion, up to 12 weeks ]
  3. Incidence of Electrocardiogram (ECG) Findings [Safety and Tolerability] [ Time Frame: Through study completion, up to 12 weeks ]
  4. Incidence of Clinical Laboratory Tests Findings [Safety and Tolerability] [ Time Frame: Through study completion, up to 12 weeks ]

Secondary Outcome Measures :
  1. MDGN-002 Plasma Concentration [ Time Frame: Through study completion, up to 12 weeks ]
  2. Change from baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD) [ Time Frame: Baseline to 8 weeeks of treatment ]
  3. Change from baseline in Crohn's Disease Activity Index (CDAI) [ Time Frame: Baseline to 8 weeeks of treatment ]
  4. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). [ Time Frame: Baseline to 8 weeeks of treatment ]
  5. Change from baseline in abdominal pain and loose/watery stool frequency [ Time Frame: Baseline to 8 weeeks of treatment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169894


Locations
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United States, Georgia
Egleston Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Chantrice Rogers    404-727-9270    chroger@emory.edu   
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08900
Contact: Lisa Wagenseller    856-753-7335 ext 321    lwagenseller@hritrials.com   
United States, Pennsylvania
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Reena Rai    215-662-8919    Reena.Rai@uphs.upenn.edu   
The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Caitlin Walsh    267-426-9249    IBDRESEARCH@email.chop.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Erin Landry    615-322-4573    erin.vozar@vumc.org   
Sponsors and Collaborators
Aevi Genomic Medicine

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Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT03169894    
Other Study ID Numbers: MDGN-002-CD-101
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs