Ulcerative ColitisPhase 2SEGMENTNCT02808390
Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
A Phase 2 study testing GED-0507-34-Levo 80 mg and GED-0507-34-Levo 160 mg in people with Ulcerative Colitis, run by PPM Services S.A. at 60 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- GED-0507-34-Levo 80 mg and GED-0507-34-Levo 160 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 60 sitesin 10 countries
- Study dates
- 28 Nov 2016to 31 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
60 sites in 10 countries.
60 sites in 10 countries
United States11 sites
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
Cook Children's Medical Center
Fort Worth, Texas, 76104
Envision Clinical Research, LLC
Laredo, Texas, 78041
Center for Advanced Gastroenterology, PLLC
Maitland, Florida, 32751
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653
Mount Sinai
New York, New York, 10029
IMIC, Inc
Palmetto Bay, Florida, 33157
BRCR Medical Center, Inc
Pembroke Pines, Florida, 33028
Sagact, Pllc
San Antonio, Texas, 78212
Clinical Applications Laboratories, Inc.
San Diego, California, 92103
Penn State University Milton S. Hershey Medical Center
State College, Pennsylvania, 16803
Ukraine11 sites
Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU
Kyiv, 03110
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, 04107
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
Lviv, 79010
Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
Lviv, 79013
CI Odesa Regional Clinical Hospital, Center of Gastroenterology
Odesa, 65025
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE
Sumy, 40022
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, 88018
Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, 21005
CI City Clinical Hospital #6 Dept of Gastroenterology
Zaporizhzhya, 69035
CI City Hospital #1, Dept of Surgery
Zaporizhzhya, 69104
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhya, 69600
Hungary7 sites
Principal SMO Kft.
Baja, 6500
Semmelweis Egyetem
Budapest, 1088
Endomedix Diagnosztikai Kozpont
Budapest, 1139
Debreceni Egyetem Klinikai Kozpont
Debrecen, H-4032
Bugat Pal Korhaz, Gasztroenterologia
Gyöngyös, 3200
Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly
Kaposvár, 7400
Mazso-Pharma Kutatasfejlesztesi Kft
Szeged, 6722
Bulgaria6 sites
Medical Centre "Asklepii", OOD
Dupnitsa, 2600
MHAT - Pazardzhik AD
Pazardzhik, 4400
UMHAT "Sv. Georgi", EAD
Plovdiv, 4002
MHAT "Sv. Karidad", EAD
Plovdiv, 4004
MHAT - Silistra AD
Silistra, 7500
MHAT "Sv. Petka" - Vidin, AD
Vidin, 3700
France6 sites
CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie
Amiens, 80054
Cabinet Médical de Gastro-entérologie Dr.Lesage
Armentières, 59280
Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif
Lille, 59037
Cabinet Médical de Gastroentérologie Dr. Bismuth
Lille, 59130
Cabinet Médical de Gastroentérologie Dr. Ben Ali
Roubaix, 59100
Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille
Tourcoing, 59200
Latvia5 sites
Polana D LLC
Daugavpils, LV-5417
J.Seleznovs Doctor Practice
Jelgava, LV-3001
Health Center 4, Affiliate Diagnostic Center
Riga, LV-1003
Riga East Clinical University Hospital
Riga, LV-1038
Pauls Stradins Clinical University Hospital SLLC
Riga, LV1002
Poland5 sites
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100
Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office
Rzeszów, 35-302
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin, 71-685
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, 53-333
Italy4 sites
Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche
Milan, 20122
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna
Roma, 00133
Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC
Rome, 00168
Slovakia3 sites
Alian s.r.o.
Bardejov, 08501
B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova
Košice, 04022
Gastromedic, s.r.o
Nové Zámky, 94002
Canada2 sites
Brandon Medical Arts Clinic
Brandon, Manitoba, R7A 0N7
Humber River Hospital
Toronto, Ontario, M3M0B2
About this study
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
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.
Read the 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
- Conditions
- Ulcerative Colitis
- Being tested
- GED-0507-34-Levo 80 mg, GED-0507-34-Levo 160 mg, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GED-0507-34-Levo 80 mgDrug
GED-0507-34-Levo 80 mg BID for 8 Weeks
GED-0507-34-Levo 160 mgDrug
GED-0507-34-Levo 160 mg BID for 8 Weeks
PlaceboDrug
Placebo BID for 8 Weeks
| Study group | Role | What they receive |
|---|---|---|
| 80 mg BID | Experimental | GED-0507-34-Levo 80 mg BID for 8 Weeks Receives: Drug: GED-0507-34-Levo 80 mg |
| 160 mg BID | Experimental | GED-0507-34-Levo 160 mg BID for 8 Weeks Receives: Drug: GED-0507-34-Levo 160 mg |
| Placebo | Experimental | Placebo BID for 8 Weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start28 Nov 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- PPM Services S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808390
- Sponsor's protocol ID
- GED0507-UC-001
- Acronym
- SEGMENT
- Status last verified
- Oct 2018
- First submitted
- 14 Jun 2016
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02808390
- Acronym / sponsor ID
- SEGMENT / GED0507-UC-001
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PPM Services S.A.University, hospital or other
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 31 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 80 mg BID | Experimental | Drug: GED-0507-34-Levo 80 mgGED-0507-34-Levo 80 mg BID for 8 Weeks |
| 160 mg BID | Experimental | Drug: GED-0507-34-Levo 160 mgGED-0507-34-Levo 160 mg BID for 8 Weeks |
| Placebo | Experimental | Drug: PlaceboPlacebo BID for 8 Weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GED-0507-34-Levo 80 mgGED-0507-34-Levo 80 mg BID for 8 Weeks | Drug | 80 mg BID |
| GED-0507-34-Levo 160 mgGED-0507-34-Levo 160 mg BID for 8 Weeks | Drug | 160 mg BID |
| PlaceboPlacebo BID for 8 Weeks | Drug | Placebo |
Primary outcome
Efficacy on Ulcerative Colitis Disease Activity Index
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GED-0507-34-Levo 80 mg and GED-0507-34-Levo 160 mg in people with Ulcerative Colitis, run by PPM Services S.A. at 60 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Ukraine, Hungary, Bulgaria, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy on Ulcerative Colitis Disease Activity Index (time frame: up to 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.