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

October 31, 2018 updated by: PPM Services S.A.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Medical Centre "Asklepii", OOD
      • Pazardzhik, Bulgaria, 4400
        • MHAT - Pazardzhik AD
      • Plovdiv, Bulgaria, 4002
        • UMHAT "Sv. Georgi", EAD
      • Plovdiv, Bulgaria, 4004
        • MHAT "Sv. Karidad", EAD
      • Silistra, Bulgaria, 7500
        • MHAT - Silistra AD
      • Vidin, Bulgaria, 3700
        • MHAT "Sv. Petka" - Vidin, AD
  • Canada
    • Manitoba
      • Brandon, Manitoba, Canada, R7A 0N7
        • Brandon Medical Arts Clinic
    • Ontario
      • Toronto, Ontario, Canada, M3M0B2
        • Humber River Hospital
  • France
      • Amiens Cedex, France, 80054
        • CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie
      • Armentières, France, 59280
        • Cabinet Médical de Gastro-entérologie Dr.Lesage
      • Lille, France, 59130
        • Cabinet Médical de Gastroentérologie Dr. Bismuth
      • Lille Cedex, France, 59037
        • Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif
      • Roubaix, France, 59100
        • Cabinet Médical de Gastroentérologie Dr. Ben Ali
      • Tourcoing, France, 59200
        • Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille
  • Hungary
      • Baja, Hungary, 6500
        • Principal SMO Kft.
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
      • Budapest, Hungary, 1139
        • Endomedix Diagnosztikai Kozpont
      • Debrecen, Hungary, H-4032
        • Debreceni Egyetem Klinikai Kozpont
      • Gyongyos, Hungary, 3200
        • Bugat Pal Korhaz, Gasztroenterologia
      • Kaposvar, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly
      • Szeged, Hungary, 6722
        • Mazso-Pharma Kutatasfejlesztesi Kft
  • Italy
      • Milano, Italy, 20122
        • Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna
      • Rome, Italy, 00168
        • Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC
  • Latvia
      • Daugavpils, Latvia, LV-5417
        • Polana D LLC
      • Jelgava, Latvia, LV-3001
        • J.Seleznovs Doctor Practice
      • Riga, Latvia, LV-1003
        • Health Center 4, Affiliate Diagnostic Center
      • Riga, Latvia, LV-1038
        • Riga East Clinical University Hospital
      • Riga, Latvia, LV1002
        • Pauls Stradins Clinical University Hospital SLLC
  • Poland
      • Leszno, Poland, 64-100
        • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
      • Rzeszow, Poland, 35-302
        • Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office
      • Szczecin, Poland, 71-685
        • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
      • Warszawa, Poland, 00-632
        • Centrum Zdrowia Matki, Dziecka i Mlodziezy
      • Wroclaw, Poland, 53-333
        • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
  • Slovakia
      • Bardejov, Slovakia, 08501
        • ALIAN s.r.o.
      • Kosice, Slovakia, 04022
        • B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova
      • Nove Zamky, Slovakia, 94002
        • Gastromedic, s.r.o
  • Ukraine
      • Kyiv, Ukraine, 03110
        • Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU
      • Kyiv, Ukraine, 04107
        • CI of Kyiv RC Kyiv Regional Clinical Hospital
      • Lviv, Ukraine, 79013
        • Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
      • Lviv, Ukraine, 79010
        • Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
      • Odesa, Ukraine, 65025
        • CI Odesa Regional Clinical Hospital, Center of Gastroenterology
      • Sumy, Ukraine, 40022
        • CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE
      • Uzhgorod, Ukraine, 88018
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21005
        • Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
      • Zaporizhzhia, Ukraine, 69600
        • CI Zaporizhzhia Regional Clinical Hospital of ZRC
      • Zaporizhzhia, Ukraine, 69035
        • CI City Clinical Hospital #6 Dept of Gastroenterology
      • Zaporizhzhia, Ukraine, 69104
        • CI City Hospital #1, Dept of Surgery
  • United States
    • California
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc.
    • Florida
      • Maitland, Florida, United States, 32751
        • Center for Advanced Gastroenterology, PLLC
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc.
      • Palmetto Bay, Florida, United States, 33157
        • IMIC, Inc
      • Pembroke Pines, Florida, United States, 33028
        • BRCR Medical Center, INC
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai
    • Pennsylvania
      • State College, Pennsylvania, United States, 16803
        • Penn State University Milton S. Hershey Medical Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • Laredo, Texas, United States, 78041
        • Envision Clinical Research, LLC
      • San Antonio, Texas, United States, 78212
        • Sagact, Pllc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PPM Services S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2016

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GED0507-UC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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