A Study of the Effectiveness and Safety of Mongersen (GED-0301) for the Treatment of Patients with Active Crohn's Disease

Overview

About this study

The purpose of this study is to test the effectiveness and safety of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Must satisfy the following to be enrolled in the study
    • Male or female ≥ 18 years
    • Active Crohn's disease as determined by the Crohn's Disease Activity Index score and the Simple Endoscopic Score for Crohn's Disease
    • Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period
    • Must have failed or experienced intolerance to at least one of the following for the treatment of crohn's disease
      • Aminosalicylates
      • Budesonide
      • Systemic corticosteroids
      • Immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate)
      • Biologics for the treatment of CD

Exclusion Criteria

  • Any of the following excludes from enrollment
    • Diagnosis of
      • Ulcerative colitis
      • Indeterminate colitis
      • Ischemic colitis
      • Microscopic colitis
      • Radiation colitis 
      • Diverticular disease-associated colitis
    • Local manifestations of Crohn's Disease such as symptomatic strictures, abscesses, short bowel syndrome or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
    • Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the screening visit
    • Ileostomy or a colostomy
    • A history of any clinically significant medical condition that, in the investigator's opinion, would prevent participation in the study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Shabana Pasha, M.D.

Closed for enrollment

More information

Publications

  • The treatment of perianal fistulas remains a clinical challenge despite the significant advances that have been made in the management of luminal inflammatory bowel disease. In combination with medical therapies, surgical management of perianal fistulas is important for both infection control and definitive repair. Older surgical techniques include the placement of draining and cutting setons and endorectal advancement flaps. Newer surgical techniques that utilize lasers and video-assisted technology are being studied to help patients with chronic, refractory perianal fistulas. In addition to surgical management, less-invasive endoscopic techniques, including endoscopic fistulotomy and endoscopic clipping, are being investigated. Looking forward, allogeneic and autologous adult mesenchymal stem cells are being evaluated to induce fistula healing and improve rates of fistula closure. Here, in the second of a 2-part series on perianal fistulas in patients with Crohn's disease, we discuss the current surgical management of perianal fistulas as well as newer endoscopic techniques and future therapies. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20239995

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