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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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