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

Phase 2

Terminated

Interventions: Drug: GED-0507-34-Levo 160 mg
Drug: Placebo
Drug: GED-0507-34-Levo 80 mg

Brief Summary: 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.

Detailed Description: This is a Phase 2, Proof of Concept, 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 Ulcerative Colitis.

The study will consist of 3 phases:

* Screening Phase - up to 4 weeks

* Double-blind Placebo-controlled Phase - Weeks 0 to 8

* Follow-up Phase - Week 9

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Efficacy on Ulcerative Colitis Disease Activity Index	up to 8 Weeks	After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated.

Secondary Outcome Measures

Name	Time	Method

Locations (60): Clinical Applications Laboratories, Inc.
🇺🇸
San Diego, California, United States
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
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Clinical Applications Laboratories, Inc.
🇺🇸San Diego, California, United States