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

PPM Services S.A.

Status and phase: Terminated; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: GED-0507-34-Levo 80 mg; Drug: GED-0507-34-Levo 160 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02808390

GED0507-UC-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 3 patient groups

80 mg BID

Experimental group

Description:

GED-0507-34-Levo 80 mg BID for 8 Weeks

Treatment:

Drug: GED-0507-34-Levo 80 mg

160 mg BID

Experimental group

Description:

GED-0507-34-Levo 160 mg BID for 8 Weeks

Treatment:

Drug: GED-0507-34-Levo 160 mg

Placebo

Experimental group

Description:

Placebo BID for 8 Weeks

Treatment:

Drug: Placebo