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


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Verified May 2017 by Aevi Genomic Medicine

Sponsor:

Information provided by (Responsible Party):

Aevi Genomic Medicine

ClinicalTrials.gov Identifier:

NCT03169894

First received: May 24, 2017

Last updated: May 25, 2017

Last verified: May 2017

This is a Phase 1b, open-label, dose-escalation, signal-finding, single 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.

Crohn Disease Drug: MDGN-002 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase Ib 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

Primary Outcome Measures:

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Through study completion, up to 12 weeks ]
  • Incidence of Vital Signs 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 Clinical Laboratory Tests Findings [Safety and Tolerability] [ Time Frame: Through study completion, up to 12 weeks ]

Secondary Outcome Measures:

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Through study completion, up to 12 weeks ]
  • Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Through study completion, up to 12 weeks ]
  • Area under the plasma drug concentration-time curve (AUC0-inf) [ Time Frame: Through study completion, up to 12 weeks ]
  • Terminal Half Life (T½ ) of MDGN-002 [ Time Frame: Through study completion, up to 12 weeks ]
  • 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 Crohn’s Disease Activity Index (CDAI) [ 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 ]
  • Change from baseline in abdominal pain and loose/watery stool frequency [ Time Frame: Baseline to 8 weeeks of treatment ]

Estimated Enrollment: 8
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is male or female, ≥18 to 30 years of age.
  2. Subject has a documented diagnosis of pediatric-onset CD before 18 years of age via endoscopy/colonoscopy.
  3. Subject has moderate to severe, active CD as evidenced by Crohn’s Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03169894

The Center for Pediatric Inflammatory Bowel Disease, Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Contact: Caitlin Walsh    267-426-9249    IBDRESEARCH@email.chop.edu   

Aevi Genomic Medicine

Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT03169894     History of Changes
Other Study ID Numbers: MDGN-002-CD-101
Study First Received: May 24, 2017
Last Updated: May 25, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2017