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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: GED-0507-34-Levo 80 mg
* Drug: GED-0507-34-Levo 160 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 80 mg BID<br>GED-0507-34-Levo 80 mg BID for 8 Weeks | Drug: GED-0507-34-Levo 80 mg<br>* GED-0507-34-Levo 80 mg BID for 8 Weeks<br>|
| Experimental: 160 mg BID<br>GED-0507-34-Levo 160 mg BID for 8 Weeks | Drug: GED-0507-34-Levo 160 mg<br>* GED-0507-34-Levo 160 mg BID for 8 Weeks<br>|
| Experimental: Placebo<br>Placebo BID for 8 Weeks | Drug: Placebo<br>* Placebo BID for 8 Weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy on Ulcerative Colitis Disease Activity Index | 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. | up to 8 Weeks |