Clinical trial NCT02808390: Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: PPM Services S.A.
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Efficacy on Ulcerative Colitis Disease Activity Index
timeFrame: up to 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: Maitland
country: United States
facility: Center for Advanced Gastroenterology, PLLC
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc
state: Florida
city: Pembroke Pines
country: United States
facility: BRCR Medical Center, Inc
state: Florida
city: New York
country: United States
facility: Mount Sinai
state: New York
city: State College
country: United States
facility: Penn State University Milton S. Hershey Medical Center
state: Pennsylvania
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Laredo
country: United States
facility: Envision Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Sagact, Pllc
state: Texas
city: Dupnitsa
country: Bulgaria
facility: Medical Centre "Asklepii", OOD
city: Pazardzhik
country: Bulgaria
facility: MHAT - Pazardzhik AD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sv. Georgi", EAD
city: Plovdiv
country: Bulgaria
facility: MHAT "Sv. Karidad", EAD
city: Silistra
country: Bulgaria
facility: MHAT - Silistra AD
city: Vidin
country: Bulgaria
facility: MHAT "Sv. Petka" - Vidin, AD
city: Brandon
country: Canada
facility: Brandon Medical Arts Clinic
state: Manitoba
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Amiens Cedex
country: France
facility: CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie
city: Armentières
country: France
facility: Cabinet Médical de Gastro-entérologie Dr.Lesage
city: Lille Cedex
country: France
facility: Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif
city: Lille
country: France
facility: Cabinet Médical de Gastroentérologie Dr. Bismuth
city: Roubaix
country: France
facility: Cabinet Médical de Gastroentérologie Dr. Ben Ali
city: Tourcoing
country: France
facility: Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille
city: Baja
country: Hungary
facility: Principal SMO Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Endomedix Diagnosztikai Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz, Gasztroenterologia
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly
city: Szeged
country: Hungary
facility: Mazso-Pharma Kutatasfejlesztesi Kft
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC
city: Daugavpils
country: Latvia
facility: Polana D LLC
city: Jelgava
country: Latvia
facility: J.Seleznovs Doctor Practice
city: Riga
country: Latvia
facility: Health Center 4, Affiliate Diagnostic Center
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital SLLC
city: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office
city: Szczecin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy
city: Wroclaw
country: Poland
facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew
city: Bardejov
country: Slovakia
facility: Alian s.r.o.
city: Kosice
country: Slovakia
facility: B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova
city: Nove Zamky
country: Slovakia
facility: Gastromedic, s.r.o
city: Kyiv
country: Ukraine
facility: Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Kyiv Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
city: Lviv
country: Ukraine
facility: Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
city: Odesa
country: Ukraine
facility: CI Odesa Regional Clinical Hospital, Center of Gastroenterology
city: Sumy
country: Ukraine
facility: CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE
city: Uzhgorod
country: Ukraine
facility: A. Novak Transcarpathian Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
city: Zaporizhzhia
country: Ukraine
facility: CI City Clinical Hospital #6 Dept of Gastroenterology
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1, Dept of Surgery
city: Zaporizhzhia
country: Ukraine
facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC
Study officials:
References: