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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GED-0507-34-Levo 80 mg
GED-0507-34-Levo 160 mg
Placebo
Sponsored by
PPM Services S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinical Applications Laboratories, Inc.
  • Center for Advanced Gastroenterology, PLLC
  • Advanced Research Institute, Inc.
  • IMIC, Inc
  • BRCR Medical Center, Inc
  • Mount Sinai
  • Penn State University Milton S. Hershey Medical Center
  • Texas Clinical Research Institute, LLC
  • Cook Children's Medical Center
  • Envision Clinical Research, LLC
  • Sagact, Pllc
  • Medical Centre "Asklepii", OOD
  • MHAT - Pazardzhik AD
  • UMHAT "Sv. Georgi", EAD
  • MHAT "Sv. Karidad", EAD
  • MHAT - Silistra AD
  • MHAT "Sv. Petka" - Vidin, AD
  • Brandon Medical Arts Clinic
  • Humber River Hospital
  • CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie
  • Cabinet Médical de Gastro-entérologie Dr.Lesage
  • Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif
  • Cabinet Médical de Gastroentérologie Dr. Bismuth
  • Cabinet Médical de Gastroentérologie Dr. Ben Ali
  • Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille
  • Principal SMO Kft.
  • Semmelweis Egyetem
  • Endomedix Diagnosztikai Kozpont
  • Debreceni Egyetem Klinikai Kozpont
  • Bugat Pal Korhaz, Gasztroenterologia
  • Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly
  • Mazso-Pharma Kutatasfejlesztesi Kft
  • Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna
  • Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC
  • Polana D LLC
  • J.Seleznovs Doctor Practice
  • Health Center 4, Affiliate Diagnostic Center
  • Riga East Clinical University Hospital
  • Pauls Stradins Clinical University Hospital SLLC
  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
  • Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office
  • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
  • Alian s.r.o.
  • B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova
  • Gastromedic, s.r.o
  • Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU
  • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
  • Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
  • CI Odesa Regional Clinical Hospital, Center of Gastroenterology
  • CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE
  • A. Novak Transcarpathian Regional Clinical Hospital
  • Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
  • CI City Clinical Hospital #6 Dept of Gastroenterology
  • CI City Hospital #1, Dept of Surgery
  • CI Zaporizhzhia Regional Clinical Hospital of ZRC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

80 mg BID

160 mg BID

Placebo

Arm Description

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

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

Placebo BID for 8 Weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2016
Last Updated
October 31, 2018
Sponsor
PPM Services S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02808390
Brief Title
Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
Acronym
SEGMENT
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
November 28, 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PPM Services S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
80 mg BID
Arm Type
Experimental
Arm Description
GED-0507-34-Levo 80 mg BID for 8 Weeks
Arm Title
160 mg BID
Arm Type
Experimental
Arm Description
GED-0507-34-Levo 160 mg BID for 8 Weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo BID for 8 Weeks
Intervention Type
Drug
Intervention Name(s)
GED-0507-34-Levo 80 mg
Intervention Description
GED-0507-34-Levo 80 mg BID for 8 Weeks
Intervention Type
Drug
Intervention Name(s)
GED-0507-34-Levo 160 mg
Intervention Description
GED-0507-34-Levo 160 mg BID for 8 Weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID for 8 Weeks
Primary Outcome Measure Information:
Title
Efficacy on Ulcerative Colitis Disease Activity Index
Description
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.
Time Frame
up to 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clinical Applications Laboratories, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Center for Advanced Gastroenterology, PLLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
IMIC, Inc
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
BRCR Medical Center, Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Penn State University Milton S. Hershey Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Envision Clinical Research, LLC
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Sagact, Pllc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Medical Centre "Asklepii", OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
MHAT - Pazardzhik AD
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
UMHAT "Sv. Georgi", EAD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MHAT "Sv. Karidad", EAD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
MHAT - Silistra AD
City
Silistra
ZIP/Postal Code
7500
Country
Bulgaria
Facility Name
MHAT "Sv. Petka" - Vidin, AD
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
Brandon Medical Arts Clinic
City
Brandon
State/Province
Manitoba
ZIP/Postal Code
R7A 0N7
Country
Canada
Facility Name
Humber River Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M0B2
Country
Canada
Facility Name
CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie
City
Amiens Cedex
ZIP/Postal Code
80054
Country
France
Facility Name
Cabinet Médical de Gastro-entérologie Dr.Lesage
City
Armentières
ZIP/Postal Code
59280
Country
France
Facility Name
Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Cabinet Médical de Gastroentérologie Dr. Bismuth
City
Lille
ZIP/Postal Code
59130
Country
France
Facility Name
Cabinet Médical de Gastroentérologie Dr. Ben Ali
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille
City
Tourcoing
ZIP/Postal Code
59200
Country
France
Facility Name
Principal SMO Kft.
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Endomedix Diagnosztikai Kozpont
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Bugat Pal Korhaz, Gasztroenterologia
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Mazso-Pharma Kutatasfejlesztesi Kft
City
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Polana D LLC
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
J.Seleznovs Doctor Practice
City
Jelgava
ZIP/Postal Code
LV-3001
Country
Latvia
Facility Name
Health Center 4, Affiliate Diagnostic Center
City
Riga
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
Riga East Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital SLLC
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
City
Szczecin
ZIP/Postal Code
71-685
Country
Poland
Facility Name
Centrum Zdrowia Matki, Dziecka i Mlodziezy
City
Warszawa
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
City
Wroclaw
ZIP/Postal Code
53-333
Country
Poland
Facility Name
Alian s.r.o.
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova
City
Kosice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
Gastromedic, s.r.o
City
Nove Zamky
ZIP/Postal Code
94002
Country
Slovakia
Facility Name
Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
CI of Kyiv RC Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
CI Odesa Regional Clinical Hospital, Center of Gastroenterology
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
A. Novak Transcarpathian Regional Clinical Hospital
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
CI City Clinical Hospital #6 Dept of Gastroenterology
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
CI City Hospital #1, Dept of Surgery
City
Zaporizhzhia
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
CI Zaporizhzhia Regional Clinical Hospital of ZRC
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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