Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

Key facts

Study ID

NCT02808390

Run by

PPM Services S.A.

People needed

19

Starts

2016-11-28

Expected to finish

2017-07-31

Last updated by the study team

2018-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18 and over at the time of signing the informed consent.
• Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.
• MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study
• Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
• Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

You may not qualify if…

• Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis.
• UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).
• Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
• Clinical signs suggestive of fulminant colitis or toxic megacolon.
• Evidence of pathogenic enteric infection.
• History of colorectal cancer or colorectal dysplasia.
• Prior use of any TNF inhibitor (or any biologic agent).
• Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
• Use of budesonide-MMx within the last 8 weeks.
• Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
• Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) within 8 weeks of the Screening Visit.

Where it is running

• Center for Advanced Gastroenterology, PLLC — Maitland, Florida, United States
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• IMIC, Inc — Palmetto Bay, Florida, United States
• BRCR Medical Center, Inc — Pembroke Pines, Florida, United States
• Mount Sinai — New York, New York, United States
• Penn State University Milton S. Hershey Medical Center — State College, Pennsylvania, United States
• Texas Clinical Research Institute, LLC — Arlington, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Envision Clinical Research, LLC — Laredo, Texas, United States
• Sagact, Pllc — San Antonio, Texas, United States
• Medical Centre "Asklepii", OOD — Dupnitsa, Bulgaria
• MHAT - Pazardzhik AD — Pazardzhik, Bulgaria
• UMHAT "Sv. Georgi", EAD — Plovdiv, Bulgaria
• MHAT "Sv. Karidad", EAD — Plovdiv, Bulgaria
• MHAT - Silistra AD — Silistra, Bulgaria
• MHAT "Sv. Petka" - Vidin, AD — Vidin, Bulgaria
• Brandon Medical Arts Clinic — Brandon, Manitoba, Canada
• Humber River Hospital — Toronto, Ontario, Canada
• CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie — Amiens, France
• Cabinet Médical de Gastro-entérologie Dr.Lesage — Armentières, France
• Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif — Lille, France
• Cabinet Médical de Gastroentérologie Dr. Bismuth — Lille, France
• Cabinet Médical de Gastroentérologie Dr. Ben Ali — Roubaix, France
• Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille — Tourcoing, France
• Clinical Applications Laboratories, Inc. — San Diego, California, United States

Full record on ClinicalTrials.gov

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