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

• Sponsor: PPM Services S.A. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02808390
• Collaborator: (none)
• Enrollment: 19
• Locations: 60
• Arms: 3
• Actual Duration (Months): 8
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: GED-0507-34-Levo 80 mg; Drug: GED-0507-34-Levo 160 mg; Drug: Placebo	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 28, 2016
• Actual Primary Completion Date: Jul 31, 2017
• Actual Study Completion Date: Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 80 mg BID GED-0507-34-Levo 80 mg BID for 8 Weeks	Drug: GED-0507-34-Levo 80 mg; GED-0507-34-Levo 80 mg BID for 8 Weeks
Experimental: 160 mg BID GED-0507-34-Levo 160 mg BID for 8 Weeks	Drug: GED-0507-34-Levo 160 mg; GED-0507-34-Levo 160 mg BID for 8 Weeks
Experimental: Placebo Placebo BID for 8 Weeks	Drug: Placebo; Placebo BID for 8 Weeks

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Applications Laboratories, Inc.	San Diego	California	United States	92103
2	Center for Advanced Gastroenterology, PLLC	Maitland	Florida	United States	32751
3	Advanced Research Institute, Inc.	New Port Richey	Florida	United States	34653
4	IMIC, Inc	Palmetto Bay	Florida	United States	33157
5	BRCR Medical Center, Inc	Pembroke Pines	Florida	United States	33028
6	Mount Sinai	New York	New York	United States	10029
7	Penn State University Milton S. Hershey Medical Center	State College	Pennsylvania	United States	16803
8	Texas Clinical Research Institute, LLC	Arlington	Texas	United States	76012
9	Cook Children's Medical Center	Fort Worth	Texas	United States	76104
10	Envision Clinical Research, LLC	Laredo	Texas	United States	78041
11	Sagact, Pllc	San Antonio	Texas	United States	78212
12	Medical Centre "Asklepii", OOD	Dupnitsa		Bulgaria	2600
13	MHAT - Pazardzhik AD	Pazardzhik		Bulgaria	4400
14	UMHAT "Sv. Georgi", EAD	Plovdiv		Bulgaria	4002
15	MHAT "Sv. Karidad", EAD	Plovdiv		Bulgaria	4004
16	MHAT - Silistra AD	Silistra		Bulgaria	7500
17	MHAT "Sv. Petka" - Vidin, AD	Vidin		Bulgaria	3700
18	Brandon Medical Arts Clinic	Brandon	Manitoba	Canada	R7A 0N7
19	Humber River Hospital	Toronto	Ontario	Canada	M3M0B2
20	CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie	Amiens Cedex		France	80054
21	Cabinet Médical de Gastro-entérologie Dr.Lesage	Armentières		France	59280
22	Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif	Lille Cedex		France	59037
23	Cabinet Médical de Gastroentérologie Dr. Bismuth	Lille		France	59130
24	Cabinet Médical de Gastroentérologie Dr. Ben Ali	Roubaix		France	59100
25	Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille	Tourcoing		France	59200
26	Principal SMO Kft.	Baja		Hungary	6500
27	Semmelweis Egyetem	Budapest		Hungary	1088
28	Endomedix Diagnosztikai Kozpont	Budapest		Hungary	1139
29	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	H-4032
30	Bugat Pal Korhaz, Gasztroenterologia	Gyongyos		Hungary	3200
31	Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly	Kaposvar		Hungary	7400
32	Mazso-Pharma Kutatasfejlesztesi Kft	Szeged		Hungary	6722
33	Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche	Milano		Italy	20122
34	Fondazione IRCCS Policlinico San Matteo	Pavia		Italy	27100
35	Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna	Roma		Italy	00133
36	Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC	Rome		Italy	00168
37	Polana D LLC	Daugavpils		Latvia	LV-5417
38	J.Seleznovs Doctor Practice	Jelgava		Latvia	LV-3001
39	Health Center 4, Affiliate Diagnostic Center	Riga		Latvia	LV-1003
40	Riga East Clinical University Hospital	Riga		Latvia	LV-1038
41	Pauls Stradins Clinical University Hospital SLLC	Riga		Latvia	LV1002
42	Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS	Leszno		Poland	64-100
43	Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office	Rzeszow		Poland	35-302
44	Niepubliczny Zaklad Opieki Zdrowotnej SONOMED	Szczecin		Poland	71-685
45	Centrum Zdrowia Matki, Dziecka i Mlodziezy	Warszawa		Poland	00-632
46	Ars-Medica S.C Rybak Maria, Rybak Zbigniew	Wroclaw		Poland	53-333
47	Alian s.r.o.	Bardejov		Slovakia	08501
48	B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova	Kosice		Slovakia	04022
49	Gastromedic, s.r.o	Nove Zamky		Slovakia	94002
50	Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU	Kyiv		Ukraine	03110
51	CI of Kyiv RC Kyiv Regional Clinical Hospital	Kyiv		Ukraine	04107
52	Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU	Lviv		Ukraine	79010
53	Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU	Lviv		Ukraine	79013
54	CI Odesa Regional Clinical Hospital, Center of Gastroenterology	Odesa		Ukraine	65025
55	CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE	Sumy		Ukraine	40022
56	A. Novak Transcarpathian Regional Clinical Hospital	Uzhgorod		Ukraine	88018
57	Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU	Vinnytsia		Ukraine	21005
58	CI City Clinical Hospital #6 Dept of Gastroenterology	Zaporizhzhia		Ukraine	69035
59	CI City Hospital #1, Dept of Surgery	Zaporizhzhia		Ukraine	69104
60	CI Zaporizhzhia Regional Clinical Hospital of ZRC	Zaporizhzhia		Ukraine	69600

Sponsors and Collaborators

• PPM Services S.A.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 24, 2017

More Information

Publications

None provided.

• Responsible Party: PPM Services S.A.
• ClinicalTrials.gov Identifier: NCT02808390
• Other Study ID Numbers: GED0507-UC-001
• First Posted: Jun 21, 2016
• Last Update Posted: Nov 27, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

Participant Flow

Recruitment Details	First Patient IN: 28 November 2016 ; Last patient OUT: 31 July 2017
Pre-assignment Detail	The study consisted of 3 phases: Screening Phase - up to 4 weeks Double-blind Placebo-controlled Phase - Weeks 0 to 8 Follow-up Phase - Week 9

Arm/Group Title	80 mg BID	160 mg BID	Placebo
Arm/Group Description	GED-0507-34-Levo 80 mg BID for 8 Weeks GED-0507-34-Levo 80 mg: GED-0507-34-Levo 80 mg BID for 8 Weeks	GED-0507-34-Levo 160 mg BID for 8 Weeks GED-0507-34-Levo 160 mg: GED-0507-34-Levo 160 mg BID for 8 Weeks	Placebo BID for 8 Weeks Placebo: Placebo BID for 8 Weeks
Period Title: Overall Study
STARTED	4	8	7
COMPLETED	2	2	4
NOT COMPLETED	2	6	3

Baseline Characteristics

Arm/Group Title	80 mg BID	160 mg BID	Placebo	Total
Arm/Group Description	GED-0507-34-Levo 80 mg BID for 8 Weeks GED-0507-34-Levo 80 mg: GED-0507-34-Levo 80 mg BID for 8 Weeks	GED-0507-34-Levo 160 mg BID for 8 Weeks GED-0507-34-Levo 160 mg: GED-0507-34-Levo 160 mg BID for 8 Weeks	Placebo BID for 8 Weeks Placebo: Placebo BID for 8 Weeks	Total of all reporting groups
Overall Participants	4	8	7	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	8 100%	7 100%	19 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex/Gender, Customized (participants) [Number]
Female	2 50%	3 37.5%	5 71.4%	10 52.6%
Male	2 50%	5 62.5%	2 28.6%	9 47.4%
Race/Ethnicity, Customized (participants) [Number]
White	4 100%	7 87.5%	6 85.7%	17 89.5%
Black or African American	0 0%	1 12.5%	0 0%	1 5.3%
Not reported	0 0%	0 0%	1 14.3%	1 5.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population 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

Arm/Group Title	80 mg BID	160 mg BID	Placebo
Arm/Group Description	80 mg BID treatment group	160 mg BID treatment group	Placebo treatment group
Measure Participants	0	0	0

Adverse Events

Time Frame	8 weeks
Arm/Group Title	80 mg BID		160 mg BID		Placebo
Arm/Group Description	GED-0507-34-Levo 80 mg BID		GED-0507-34-Levo 160 mg BID		Placebo treatment
All Cause Mortality
	80 mg BID		160 mg BID		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/8 (0%)		0/7 (0%)
Serious Adverse Events
	80 mg BID		160 mg BID		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/8 (0%)		1/7 (14.3%)
Gastrointestinal disorders
Colitis ulcerative	0/4 (0%)	0	0/8 (0%)	0	1/7 (14.3%)	1
Other (Not Including Serious) Adverse Events
	80 mg BID		160 mg BID		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/8 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.