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

NCT02808390 | Terminated Phase 2 Results

• 1 other identifier: GED0507-UC-001
• Study Type: interventional
• Target: 19
• Locations: 10 countries
• Sites: 60

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

80 mg BID

EXPERIMENTAL

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

Drug: GED-0507-34-Levo 80 mg

160 mg BID

EXPERIMENTAL

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

Drug: GED-0507-34-Levo 160 mg

Placebo

EXPERIMENTAL

Placebo BID for 8 Weeks

Drug: Placebo

Interventions

GED-0507-34-Levo 80 mg DRUG

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

80 mg BID

GED-0507-34-Levo 160 mg DRUG

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

160 mg BID

Placebo DRUG

Placebo BID for 8 Weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PPM Services S.A.: lead

Study Sites (60)

Clinical Applications Laboratories, Inc.

San Diego, California, 92103, United States

Location

Center for Advanced Gastroenterology, PLLC

Maitland, Florida, 32751, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

Location

IMIC, Inc

Palmetto Bay, Florida, 33157, United States

Location

BRCR Medical Center, Inc

Pembroke Pines, Florida, 33028, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Penn State University Milton S. Hershey Medical Center

State College, Pennsylvania, 16803, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Envision Clinical Research, LLC

Laredo, Texas, 78041, United States

Location

Sagact, Pllc

San Antonio, Texas, 78212, United States

Location

Medical Centre "Asklepii", OOD

Dupnitsa, 2600, Bulgaria

Location

MHAT - Pazardzhik AD

Pazardzhik, 4400, Bulgaria

Location

UMHAT "Sv. Georgi", EAD

Plovdiv, 4002, Bulgaria

Location

MHAT "Sv. Karidad", EAD

Plovdiv, 4004, Bulgaria

Location

MHAT - Silistra AD

Silistra, 7500, Bulgaria

Location

MHAT "Sv. Petka" - Vidin, AD

Vidin, 3700, Bulgaria

Location

Brandon Medical Arts Clinic

Brandon, Manitoba, R7A 0N7, Canada

Location

Humber River Hospital

Toronto, Ontario, M3M0B2, Canada

Location

CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie

Amiens, 80054, France

Location

Cabinet Médical de Gastro-entérologie Dr.Lesage

Armentières, 59280, France

Location

Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif

Lille, 59037, France

Location

Cabinet Médical de Gastroentérologie Dr. Bismuth

Lille, 59130, France

Location

Cabinet Médical de Gastroentérologie Dr. Ben Ali

Roubaix, 59100, France

Location

Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille

Tourcoing, 59200, France

Location

Principal SMO Kft.

Baja, 6500, Hungary

Location

Semmelweis Egyetem

Budapest, 1088, Hungary

Location

Endomedix Diagnosztikai Kozpont

Budapest, 1139, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, H-4032, Hungary

Location

Bugat Pal Korhaz, Gasztroenterologia

Gyöngyös, 3200, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly

Kaposvár, 7400, Hungary

Location

Mazso-Pharma Kutatasfejlesztesi Kft

Szeged, 6722, Hungary

Location

Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche

Milan, 20122, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna

Roma, 00133, Italy

Location

Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC

Rome, 00168, Italy

Location

Polana D LLC

Daugavpils, LV-5417, Latvia

Location

J.Seleznovs Doctor Practice

Jelgava, LV-3001, Latvia

Location

Health Center 4, Affiliate Diagnostic Center

Riga, LV-1003, Latvia

Location

Riga East Clinical University Hospital

Riga, LV-1038, Latvia

Location

Pauls Stradins Clinical University Hospital SLLC

Riga, LV1002, Latvia

Location

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, 64-100, Poland

Location

Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office

Rzeszów, 35-302, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

Szczecin, 71-685, Poland

Location

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warsaw, 00-632, Poland

Location

Ars-Medica S.C Rybak Maria, Rybak Zbigniew

Wroclaw, 53-333, Poland

Location

Alian s.r.o.

Bardejov, 08501, Slovakia

Location

B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova

Košice, 04022, Slovakia

Location

Gastromedic, s.r.o

Nové Zámky, 94002, Slovakia

Location

Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU

Kyiv, 03110, Ukraine

Location

CI of Kyiv RC Kyiv Regional Clinical Hospital

Kyiv, 04107, Ukraine

Location

Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

Lviv, 79010, Ukraine

Location

Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU

Lviv, 79013, Ukraine

Location

CI Odesa Regional Clinical Hospital, Center of Gastroenterology

Odesa, 65025, Ukraine

Location

CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE

Sumy, 40022, Ukraine

Location

A. Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, 88018, Ukraine

Location

Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

Vinnytsia, 21005, Ukraine

Location

CI City Clinical Hospital #6 Dept of Gastroenterology

Zaporizhzhia, 69035, Ukraine

Location

CI City Hospital #1, Dept of Surgery

Zaporizhzhia, 69104, Ukraine

Location

CI Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhia, 69600, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Salvatore Bellinvia
• Organization: PPM Services

sbellinvia@ppmservices.ch

+41916961710

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 21, 2016
• Study Start: November 28, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: November 27, 2018
• Results First Posted: October 31, 2018

Record last verified: 2018-10

Locations

HU (7); BU (6); LA (5); SL (3); US (11); CA (2); UA (11); FR (6); PL (5); IT (4)