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Crohn's DiseasePhase 2NCT01466374

Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

A Phase 2 study testing BMS-936557 (Anti-IP-10 Antibody) in people with Crohn's Disease, run by Bristol-Myers Squibb at 33 sites in 8 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 for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
BMS-936557 (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
121 participants
Where
33 sitesin 8 countries
Study dates
Dec 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

  • Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
  • Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
  • In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)

Who cannot join

  • Ulcerative colitis (UC) or indeterminate colitis
  • Short bowel syndrome
  • Known stricture or noninflammatory stenosis leading to symptoms of obstruction
  • Current stoma or current need for colostomy or ileostomy

Trial locations and contacts

33 sites in 8 countries.

33 sites in 8 countries

United States10 sites

  • University Of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr

    Chevy Chase, Maryland, 20815

  • Consultants For Clinical Research

    Cincinnati, Ohio, 45219

  • Nyu Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Gastroenterology Research Of New Orleans

    Hammond, Louisiana, 70403

  • Midwest Center For Clinical Research

    Lees Summit, Missouri, 64064

  • Mount Sinai School Of Medicine

    New York, New York, 10029

  • Gastroenterology Research Of San Antonio

    San Antonio, Texas, 78229

  • Southern California Medical Gastroenterology Group

    Santa Monica, California, 90404

  • Shafran Gasteroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

France6 sites

  • Local Institution

    Amiens, 80054

  • Local Institution

    Clichy, 92110

  • Local Institution

    Nice, 06200

  • Local Institution

    Pessac, 33064

  • Local Institution

    Rouen, 76031

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Hungary4 sites

  • Local Institution

    Budapest, 1083

  • Local Institution

    Budapest, 1088

  • Local Institution

    Budapest, H-1115

  • Local Institution

    Debrecen, 4012

Other trials in Hungary

Poland4 sites

  • Local Institution

    Krakow, 31-501

  • Local Institution

    Rzeszów, 35-068

  • Local Institution

    Warsaw, 02-507

  • Local Institution

    Warsaw, 03-580

Other trials in Poland

Israel3 sites

  • Local Institution

    Haifa, 31048

  • Local Institution

    Kfar Saba, 44281

  • Local Institution

    Nazareth, 16100

Other trials in Israel

South Africa3 sites

  • Local Institution

    Claremont, Western Cape, 7708

  • Local Institution

    Overport, KwaZulu-Natal, 4091

  • Local Institution

    Panorama, Western Cape, 7506

Other trials in South Africa

Belgium2 sites

  • Local Institution

    Brussels, 1090

  • Local Institution

    Leuven, 3000

Other trials in Belgium

Puerto Rico1 site

  • University Of Puerto Rico School Of Medicine

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

Read the detailed description

Anti-IP10: Anti Interferon-inducible ligand 10

Conditions
Crohn's Disease
Being tested
Placebo, BMS-936557 (Anti-IP-10 Antibody)
Medical subject headings
Crohn Disease

What participants receive

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

  • PlaceboDrug

    Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks

  • PlaceboDrug

    Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days

  • BMS-936557 (Anti-IP-10 Antibody)Drug

    Also called Anti-IP-10 Antibody

    Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks

  • BMS-936557 (Anti-IP-10 Antibody)Drug

    Also called Anti-IP-10 Antibody

    Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks

  • BMS-936557 (Anti-IP-10 Antibody)Drug

    Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days

  • BMS-936557 (Anti-IP-10 Antibody)Drug

    Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days

  • BMS-936557 (Anti-IP-10 Antibody)Drug

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

Study groups in NCT01466374
Study groupRoleWhat they receive
Cohort 1: InductionExperimentalPlacebo
Receives: Drug: Placebo
Cohort 2: InductionExperimentalAnti-IP-10 Antibody
Receives: Drug: BMS-936557 (Anti-IP-10 Antibody)
Cohort 3: InductionExperimentalAnti-IP-10 Antibody
Receives: Drug: BMS-936557 (Anti-IP-10 Antibody)
Cohort 1: MaintenanceExperimentalPlacebo
Receives: Drug: Placebo
Cohort 2: MaintenanceExperimentalAnti-IP-10 Antibody
Receives: Drug: BMS-936557 (Anti-IP-10 Antibody)
Cohort 3: MaintenanceExperimentalAnti-IP-10 Antibody
Receives: Drug: BMS-936557 (Anti-IP-10 Antibody)
Cohort 1: Open LabelExperimentalAnti-IP-10 Antibody
Receives: Drug: BMS-936557 (Anti-IP-10 Antibody)

What is being measured

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

  1. Clinical remission (CDAI score of <150)

    CDAI: Crohn's Disease Activity Index

    Measured: Week 11

Secondary outcomes (4)

  1. Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)

    Measured: Week 7 and Week 11

  2. Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)

    Measured: Week 7 and Week 11

  3. Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

    Measured: Week 11

  4. Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values

    AE - Adverse Event SAE - Serious Adverse Event

    Measured: 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 posted8 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJun 2014
  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
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01466374
Sponsor's protocol ID
IM129-008
Other IDs
2011-002981-19
Status last verified
Sep 2015
First submitted
3 Nov 2011
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-gamma-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005.

    PubMed 28333187

  • Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.

    PubMed 25935574

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-936557 (Anti-IP-10 Antibody) in people with Crohn's Disease, run by Bristol-Myers Squibb at 33 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 3 inclusion and 4 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 33 sites in United States, France, Hungary, Poland, Israel 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. 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?

Clinical remission (CDAI score of <150) (time frame: Week 11). 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 NCT01466374, which also lists 2 linked publications.

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.

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