Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Overview

About this study

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study.

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:

Subjects must satisfy the following criteria to be enrolled in the study:

Male or female ≥ 18 years
Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period
Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
Local manifestations of Crohn's Disease (CD) such as symptomatic/severe 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
Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating 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
Rochester, Minn. Mayo Clinic principal investigator Edward Loftus, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, 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

Clinical Trials