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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02808390
• Date of registration: 14/06/2016
• Prospective Registration: Yes
• Primary sponsor: PPM Services S.A.
• Public title: Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC SEGMENT
• Scientific title: 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
• Date of first enrolment: November 28, 2016
• Target sample size: 19
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02808390
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Canada, France, Hungary, Italy, Latvia, Poland, Slovakia, Ukraine, United States

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: GED-0507-34-Levo 160 mg

Drug: GED-0507-34-Levo 80 mg

Drug: Placebo

Primary Outcome(s)

Efficacy on Ulcerative Colitis Disease Activity Index [Time Frame: up to 8 Weeks]

Secondary ID(s)

GED0507-UC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02808390