Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT02808390
- Lead Sponsor
- PPM Services S.A.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 160 mg BID GED-0507-34-Levo 160 mg GED-0507-34-Levo 160 mg BID for 8 Weeks Placebo Placebo Placebo BID for 8 Weeks 80 mg BID GED-0507-34-Levo 80 mg GED-0507-34-Levo 80 mg BID for 8 Weeks
- Primary Outcome Measures
Name Time Method Efficacy on Ulcerative Colitis Disease Activity Index 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Medical Centre "Asklepii", OOD
🇧🇬Dupnitsa, Bulgaria
MHAT "Sv. Karidad", EAD
🇧🇬Plovdiv, Bulgaria
Endomedix Diagnosztikai Kozpont
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Bugat Pal Korhaz, Gasztroenterologia
🇭🇺Gyongyos, Hungary
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
🇵🇱Szczecin, Poland
Alian s.r.o.
🇸🇰Bardejov, Slovakia
Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
🇺🇦Vinnytsia, Ukraine
CI City Hospital #1, Dept of Surgery
🇺🇦Zaporizhzhia, Ukraine
Polana D LLC
🇱🇻Daugavpils, Latvia
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
🇵🇱Leszno, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
🇵🇱Warszawa, Poland
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE
🇺🇦Sumy, Ukraine
Center for Advanced Gastroenterology, PLLC
🇺🇸Maitland, Florida, United States
Humber River Hospital
🇨🇦Toronto, Ontario, Canada
MHAT - Pazardzhik AD
🇧🇬Pazardzhik, Bulgaria
Envision Clinical Research, LLC
🇺🇸Laredo, Texas, United States
Mount Sinai
🇺🇸New York, New York, United States
BRCR Medical Center, Inc
🇺🇸Pembroke Pines, Florida, United States
MHAT - Silistra AD
🇧🇬Silistra, Bulgaria
IMIC, Inc
🇺🇸Palmetto Bay, Florida, United States
Sagact, Pllc
🇺🇸San Antonio, Texas, United States
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie
🇫🇷Amiens Cedex, France
Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche
🇮🇹Milano, Italy
Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC
🇮🇹Rome, Italy
Principal SMO Kft.
🇭🇺Baja, Hungary
Health Center 4, Affiliate Diagnostic Center
🇱🇻Riga, Latvia
Riga East Clinical University Hospital
🇱🇻Riga, Latvia
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna
🇮🇹Roma, Italy
Semmelweis Egyetem
🇭🇺Budapest, Hungary
CI of Kyiv RC Kyiv Regional Clinical Hospital
🇺🇦Kyiv, Ukraine
Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif
🇫🇷Lille Cedex, France
Cabinet Médical de Gastro-entérologie Dr.Lesage
🇫🇷Armentières, France
Cabinet Médical de Gastroentérologie Dr. Bismuth
🇫🇷Lille, France
Cabinet Médical de Gastroentérologie Dr. Ben Ali
🇫🇷Roubaix, France
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Clinical Applications Laboratories, Inc.
🇺🇸San Diego, California, United States
Penn State University Milton S. Hershey Medical Center
🇺🇸State College, Pennsylvania, United States
Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille
🇫🇷Tourcoing, France
Mazso-Pharma Kutatasfejlesztesi Kft
🇭🇺Szeged, Hungary
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
🇺🇦Lviv, Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
🇺🇦Zaporizhzhia, Ukraine
MHAT "Sv. Petka" - Vidin, AD
🇧🇬Vidin, Bulgaria
UMHAT "Sv. Georgi", EAD
🇧🇬Plovdiv, Bulgaria
Pauls Stradins Clinical University Hospital SLLC
🇱🇻Riga, Latvia
B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova
🇸🇰Kosice, Slovakia
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
🇵🇱Wroclaw, Poland
Gastromedic, s.r.o
🇸🇰Nove Zamky, Slovakia
J.Seleznovs Doctor Practice
🇱🇻Jelgava, Latvia
Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office
🇵🇱Rzeszow, Poland
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
CI Odesa Regional Clinical Hospital, Center of Gastroenterology
🇺🇦Odesa, Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
🇺🇦Uzhgorod, Ukraine
Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly
🇭🇺Kaposvar, Hungary
CI City Clinical Hospital #6 Dept of Gastroenterology
🇺🇦Zaporizhzhia, Ukraine
Brandon Medical Arts Clinic
🇨🇦Brandon, Manitoba, Canada