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Colitis, UlcerativePhase 2NCT01294410

Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

A Phase 2 study testing Anti-IP-10 Antibody in people with Colitis, Ulcerative, run by Bristol-Myers Squibb at 75 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Anti-IP-10 Antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
75 sitesin 14 countries
Study dates
Mar 2011to Dec 2014
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

  • Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
  • Mayo score ≥6 with an endoscopic subscore of ≥2
  • Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Who cannot join

  • Diagnosis of Crohn's Disease or Indeterminate Colitis
  • Diagnosis of UC that is limited to the rectum
  • Evidence of fulminant colitis, toxic megacolon, or bowel perforation
  • Current need for a colostomy or ileostomy
  • Previous total or subtotal colectomy

Trial locations and contacts

75 sites in 14 countries.

75 sites in 14 countries

United States23 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • University Of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Charlotte Gastroenterology & Hepatology, Pllc

    Charlotte, North Carolina, 28207

  • Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr

    Chevy Chase, Maryland, 20815

  • Consultants For Clinical Research

    Cincinnati, Ohio, 45219

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • University Of Florida

    Gainesville, Florida, 32610

  • Long Island Clinical Research Assoc., Llp

    Great Neck, New York, 11021

  • Gastroenterology Research Of New Orleans

    Hammond, Louisiana, 70403

  • University Of California, San Diego

    La Jolla, California, 92093

  • Westglen Gastrointestinal Consultants

    Lee's Summit, Missouri, 64064

  • University Of Kentucky

    Lexington, Kentucky, 40536

  • Gastroenterology Research Of Lima

    Lima, Ohio, 45806

  • University Of Louisville

    Louisville, Kentucky, 40202

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Mount Sinai School Of Medicine

    New York, New York, 10029

  • Minnesota Gastroenterology, Pa

    Plymouth, Minnesota, 55446

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Gastroenterology Research Of San Antonio

    San Antonio, Texas, 78229

  • Santa Monica Research Institute

    Santa Monica, California, 90404

  • Gastroenterology Research Of Tyler (Gerty)

    Tyler, Texas, 75701

  • Western States Clinical Research Inc.

    Wheat Ridge, Colorado, 80033

  • Shafran Gasteroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

Australia6 sites

  • Local Institution

    Concord, New South Wales, 2139

  • Local Institution

    Fremantle, Western Australia, 6959

  • Local Institution

    Garran, Australian Capital Territory, 2605

  • Local Institution

    Herston, Queensland, 4029

  • Local Institution

    Parkville, Victoria, 3050

  • Local Institution

    South Brisbane, Victoria, 4101

Other trials in Australia

Mexico6 sites

  • Local Institution

    Guadalajara, Jalisco, 44340

  • Local Institution

    Guadalajara, Jalisco, 45040

  • Local Institution

    Mexico City, Mexico City, 14080

  • Local Institution

    Mexico, D. F., Mexico City, 06726

  • Local Institution

    Monterrey, Nuevo León, 64460

  • Local Institution

    Veracruz, Veracruz, 91900

Other trials in Mexico

France5 sites

  • Local Institution

    Clichy, 92110

  • Local Institution

    Lille, 59037

  • Local Institution

    Nice, 06200

  • Local Institution

    Pessac, 33600

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Canada4 sites

  • Local Institution

    Calgary, Alberta, T2N 4Z6

  • Local Institution

    Kingston, Ontario, K7L 5G2

  • Local Institution

    Vancouver, British Columbia, V6Z 2K5

  • Local Institution

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Germany4 sites

  • Local Institution

    Hamburg, 20148

  • Local Institution

    Kiel, 24105

  • Local Institution

    Münster, 48149

  • Local Institution

    Münster, 48155

Other trials in Germany

Hungary4 sites

  • Local Institution

    Budapest, 1088

  • Local Institution

    Budapest, 1115

  • Local Institution

    Debrecen, 4012

  • Local Institution

    Szeged, 6720

Other trials in Hungary

Italy4 sites

  • Local Institution

    Padova, 35128

  • Local Institution

    Roma, 00152

  • Local Institution

    San Donato Milanese (mi), 20097

  • Local Institution

    San Giovanni Rotondo (fg), 71013

Other trials in Italy

Poland4 sites

  • Local Institution

    Rzeszów, 35-068

  • Local Institution

    Sosnowiec, 41-200

  • Local Institution

    Warsaw, 02-507

  • Local Institution

    Warsaw, 03-580

Other trials in Poland

South Africa4 sites

  • Local Institution

    Claremont, Western Cape, 7708

  • Local Institution

    Overport, KwaZulu-Natal, 4091

  • Local Institution

    Paarl, 7646

  • Local Institution

    Panorama, Western Cape, 7506

Other trials in South Africa

Belgium3 sites

  • Local Institution

    Bonheiden, 2820

  • Local Institution

    Edegem, 2650

  • Local Institution

    Leuven, B-3000

Other trials in Belgium

Brazil3 sites

  • Local Institution

    Botucatu, São Paulo, 18618

  • Local Institution

    Goiânia, Goiás, 74535

  • Local Institution

    Rio de Janeiro, Rio de Janeiro, 21941

Other trials in Brazil

Netherlands3 sites

  • Local Institution

    Amsterdam, 1081 HV

  • Local Institution

    Amsterdam, 1105 AZ

  • Local Institution

    Rotterdam, 3015 CE

Other trials in Netherlands

Austria2 sites

  • Local Institution

    Graz, 8036

  • Local Institution

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

Being tested
Placebo, Anti-IP-10 Antibody
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks

  • PlaceboDrug

    Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days

  • Anti-IP-10 AntibodyDrug

    Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks

  • Anti-IP-10 AntibodyDrug

    Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks

  • Anti-IP-10 AntibodyDrug

    Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days

  • Anti-IP-10 AntibodyDrug

    Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days

  • Anti-IP-10 AntibodyDrug

    Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days

  • Anti-IP-10 AntibodyDrug

    Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open

Study groups in NCT01294410
Study groupRoleWhat they receive
Cohort 1: InductionExperimentalPlacebo or Anti-IP-10 Antibody
Receives: Drug: Placebo; Drug: Anti-IP-10 Antibody
Cohort 2: InductionExperimentalPlacebo or Anti-IP-10 Antibody
Receives: Drug: Placebo; Drug: Anti-IP-10 Antibody
Cohort 3: InductionExperimentalPlacebo or Anti-IP-10 Antibody
Receives: Drug: Placebo; Drug: Anti-IP-10 Antibody
MaintenanceExperimentalPlacebo or Anti-IP-10 Antibody
Receives: Drug: Placebo; Drug: Anti-IP-10 Antibody
Open LabelOtherNot described
Receives: Drug: Anti-IP-10 Antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo

    Measured: End of Induction [Week 11, Induction Period-78 (IP-78)]

Secondary outcomes (4)

  1. Proportion of the subjects with clinical response of BMS-936557 with that of the placebo

    Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point

    Measured: IP-78 (Week 11)

  2. Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo

    Measured: IP-78 (Week 11)

  3. Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values

    Measured: IP-78 (Week 11)

  4. Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo

    Measured: Baseline (IP-1, Week 1) and IP-78 (Week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2012
  4. Study completionDec 2014

Resources

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
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01294410
Sponsor's protocol ID
IM129-005
Other IDs
2010-022506-41
Status last verified
Jun 2015
First submitted
10 Feb 2011
Last updated
25 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hebuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.

    PubMed 26721935

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-IP-10 Antibody in people with Colitis, Ulcerative, run by Bristol-Myers Squibb at 75 sites in 14 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 3 inclusion and 5 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 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Australia, Mexico, France, Canada and 9 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?

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?

Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo (time frame: End of Induction [Week 11, Induction Period-78 (IP-78)]). 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 NCT01294410, 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 25 Jun 2015.

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