Title
Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis
Phase
Phase 2Lead Sponsor
PPM Services S.A.Study Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Ulcerative ColitisIntervention/Treatment
ged-0507-34-levo ...Study Participants
19This 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.
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
GED-0507-34-Levo 80 mg BID for 8 Weeks
GED-0507-34-Levo 160 mg BID for 8 Weeks
Placebo BID for 8 Weeks
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.
| Event Type | Organ System | Event Term | 80 mg BID | 160 mg BID | Placebo |
|---|
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.
