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

Ulcerative Colitis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02808390
• Other study ID #: GED0507-UC-001
• Status: Terminated
• Phase: Phase 2
• Start date: November 28, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: October 2018
• Source: PPM Services S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• GED-0507-34-Levo 80 mg
GED-0507-34-Levo 80 mg BID for 8 Weeks
• GED-0507-34-Levo 160 mg
GED-0507-34-Levo 160 mg BID for 8 Weeks
• Placebo
Placebo BID for 8 Weeks

Locations

Country	Name	City	State
Bulgaria	Medical Centre "Asklepii", OOD	Dupnitsa
Bulgaria	MHAT - Pazardzhik AD	Pazardzhik
Bulgaria	MHAT "Sv. Karidad", EAD	Plovdiv
Bulgaria	UMHAT "Sv. Georgi", EAD	Plovdiv
Bulgaria	MHAT - Silistra AD	Silistra
Bulgaria	MHAT "Sv. Petka" - Vidin, AD	Vidin
Canada	Brandon Medical Arts Clinic	Brandon	Manitoba
Canada	Humber River Hospital	Toronto	Ontario
France	CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie	Amiens Cedex
France	Cabinet Médical de Gastro-entérologie Dr.Lesage	Armentières
France	Cabinet Médical de Gastroentérologie Dr. Bismuth	Lille
France	Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif	Lille Cedex
France	Cabinet Médical de Gastroentérologie Dr. Ben Ali	Roubaix
France	Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille	Tourcoing
Hungary	Principal SMO Kft.	Baja
Hungary	Endomedix Diagnosztikai Kozpont	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bugat Pal Korhaz, Gasztroenterologia	Gyongyos
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly	Kaposvar
Hungary	Mazso-Pharma Kutatasfejlesztesi Kft	Szeged
Italy	Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche	Milano
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna	Roma
Italy	Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC	Rome
Latvia	Polana D LLC	Daugavpils
Latvia	J.Seleznovs Doctor Practice	Jelgava
Latvia	Health Center 4, Affiliate Diagnostic Center	Riga
Latvia	Pauls Stradins Clinical University Hospital SLLC	Riga
Latvia	Riga East Clinical University Hospital	Riga
Poland	Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS	Leszno
Poland	Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office	Rzeszow
Poland	Niepubliczny Zaklad Opieki Zdrowotnej SONOMED	Szczecin
Poland	Centrum Zdrowia Matki, Dziecka i Mlodziezy	Warszawa
Poland	Ars-Medica S.C Rybak Maria, Rybak Zbigniew	Wroclaw
Slovakia	Alian s.r.o.	Bardejov
Slovakia	B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova	Kosice
Slovakia	Gastromedic, s.r.o	Nove Zamky
Ukraine	CI of Kyiv RC Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU	Kyiv
Ukraine	Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU	Lviv
Ukraine	Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU	Lviv
Ukraine	CI Odesa Regional Clinical Hospital, Center of Gastroenterology	Odesa
Ukraine	CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE	Sumy
Ukraine	A. Novak Transcarpathian Regional Clinical Hospital	Uzhgorod
Ukraine	Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU	Vinnytsia
Ukraine	CI City Clinical Hospital #6 Dept of Gastroenterology	Zaporizhzhia
Ukraine	CI City Hospital #1, Dept of Surgery	Zaporizhzhia
Ukraine	CI Zaporizhzhia Regional Clinical Hospital of ZRC	Zaporizhzhia
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Envision Clinical Research, LLC	Laredo	Texas
United States	Center for Advanced Gastroenterology, PLLC	Maitland	Florida
United States	Advanced Research Institute, Inc.	New Port Richey	Florida
United States	Mount Sinai	New York	New York
United States	IMIC, Inc	Palmetto Bay	Florida
United States	BRCR Medical Center, Inc	Pembroke Pines	Florida
United States	Sagact, Pllc	San Antonio	Texas
United States	Clinical Applications Laboratories, Inc.	San Diego	California
United States	Penn State University Milton S. Hershey Medical Center	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
PPM Services S.A.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 8 Weeks