Ulcerative ColitisPhase 2MDX1100-06NCT00656890
A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
A Phase 2 study testing sterile saline for injection and MDX-1100 in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 44 sites in 8 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100. 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?
- sterile saline for injection and MDX-1100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 44 sitesin 8 countries
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
- Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
- Subjects on the following medications;
- prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
- 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
- AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
- Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)
Who cannot join
- Anti-TNF therapy within 8 weeks before study drug administration
- Contraindication to colonoscopy or sigmoidoscopy
- Primary or secondary immunodeficiency
- Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
- History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
- Evidence of acute or chronic infection
- Clinically significant disease requiring medication
Trial locations and contacts
44 sites in 8 countries.
44 sites in 8 countries
Hungary9 sites
Study site
Budapest
Study site
Debrecen
Study site
Gyula
Study site
Kaposvár
Study site
Kecskemét
Study site
Nagykanizsa
Study site
Siófok
Study site
Vác
Study site
Zalaegerszeg
Ukraine8 sites
Study site
Chernivtsy
Study site
Dniepropetrovsk
Study site
Donetsk
Study site
Kharkiv
Study site
Kiev
Study site
Kyiv
Study site
Lviv
Study site
Simferopol
United States7 sites
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Dayton Science Institute
Dayton, Ohio, 45415
Mount Sinai School of Medicine
New York, New York, 10029
Advanced Medical Research Center
Port Orange, Florida, 32127
Washington University School of Medicine
St Louis, Missouri, 63110
Florida Medical Clinic-Tampa Clinic
Tampa, Florida, 33613
Czechia6 sites
Study site
Olomouc
Study site
Prague
Study site
Strakonice
Study site
Tábor
Study site
Ústí nad Labem
Study site
Valasske Mezifici
Romania5 sites
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Oradea
Study site
Tg. Mures
Study site
Timișoara
Canada3 sites
Study site
Abbotsford British Columbia, British Columbia, V2S 3N5
Study site
Toronto, Ontario, M3N 2V7
Study site
Vancouver, British Columbia, V5Z 1H2
About this study
Official title: A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis
The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.
- Conditions
- Ulcerative Colitis
- Being tested
- sterile saline for injection, MDX-1100
- Keywords
- ulcerative colitis, rectal bleeding
- Medical subject headings
- Colitis, Ulcerative, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile saline for injectionBiological
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
MDX-1100Biological
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | sterile saline for injection Receives: Biological: sterile saline for injection |
| 1 | Experimental | MDX-1100 for injection Receives: Biological: MDX-1100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mayo score at Day 57 compared with Screening
Measured: Day 57
Secondary outcomes (1)
the remission rate
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656890
- Sponsor's protocol ID
- MDX1100-06
- Other IDs
- IM129-004
- Acronym
- MDX1100-06
- Status last verified
- Sep 2015
- First submitted
- 4 Apr 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mayer L, Sandborn WJ, Stepanov Y, Geboes K, Hardi R, Yellin M, Tao X, Xu LA, Salter-Cid L, Gujrathi S, Aranda R, Luo AY. Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study. Gut. 2014 Mar;63(3):442-50. doi: 10.1136/gutjnl-2012-303424. Epub 2013 Mar 5.
PubMed 23461895
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00656890
- Acronym / sponsor ID
- MDX1100-06 / MDX1100-06
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, rectal bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Biological: sterile saline for injectionsterile saline for injection |
| 1 | Experimental | Biological: MDX-1100MDX-1100 for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
- Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
- Subjects on the following medications;
Key exclusion criteria (7 listed)
- Anti-TNF therapy within 8 weeks before study drug administration
- Contraindication to colonoscopy or sigmoidoscopy
- Primary or secondary immunodeficiency
- Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
- History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
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 |
|---|---|---|
| sterile saline for injection10mg/kg/dose sterile saline injected every other week for a total of 4 doses | Biological | 2 |
| MDX-110010mg/kg/dose MDX-1100 injected every other week for a total of 4 doses | Biological | 1 |
Primary outcome
Change in Mayo score at Day 57 compared with Screening
Time frame: Day 57
1 secondary outcome
the remission rate
Time frame: Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 23461895Mayer L, Sandborn WJ, Stepanov Y, Geboes K, Hardi R, Yellin M, Tao X, Xu LA, Salter-Cid L, Gujrathi S, Aranda R, Luo AY. Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study. Gut. 2014 Mar;63(3):442-50. doi: 10.1136/gutjnl-2012-303424. Epub 2013 Mar 5.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
44 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sterile saline for injection and MDX-1100 in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 44 sites in 8 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Hungary, Ukraine, United States, Czechia, Romania and 3 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Mayo score at Day 57 compared with Screening (time frame: Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656890, which also lists 1 linked publication.
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 12 Oct 2015.