A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

November 9, 2016 updated by: Janssen Research & Development, LLC

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study (CNTO1275CRD3002 or "UNITI-2") examines ustekinumab (an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical except without the ustekinumab antibody) given intravenously (by an IV) in adults with moderately to severely active Crohn's disease. Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab can provide benefit in Crohn's disease and also assess for any risks or side effects. Both the positive and negative outcomes of IV placebo versus two different doses of IV ustekinumab will be tracked and compared over eight weeks, in approximately 612 patients who have previously failed or were intolerant to corticosteroids or immunomodulators (methotrexate, azathioprine, or 6-mercaptopurine) or are dependent on corticosteroid medications. Patients enrolling in this study will be assigned to one of the 3 treatment groups by chance (randomly, like rolling dice), and all will receive a single IV administration of study agent at the first study visit (after the screening period), and then will be asked to return for 3 additional visits through Week 8. Patients who complete this study through the Week 8 visit and remain eligible can enter the maintenance study (CNTO1275CRD3003 or "IM-UNITI"), where they will receive additional study agent, including the administration of ustekinumab in patients who receive placebo in this study and have not had improvement in their Crohn's disease. Patients who do not enter the CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after they received study agent when they entered into this study at the Week 0 visit. .All patients will receive a single intravenous (IV) administration of study drug (placebo or ustekinumab) at the start of the study.There are 3 treatment groups in this study: Group 1: Placebo; Group 2: ustekinumab 130 mg, Group 3: weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
640

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Cairns, Australia
      • Central Queensland M C, Australia
      • Concord, Australia
      • Fremantle, Australia
      • Garran, Australia
      • Liverpool, Australia
      • Malvern, Australia
      • Parkville, Australia
  • Belgium
      • Brussel, Belgium
      • Leuven, Belgium
  • Brazil
      • Goiânia, Brazil
      • Porto Alegre, Brazil
      • Rio De Janeiro, Brazil
      • Sao Paulo, Brazil
      • São Paulo, Brazil
  • Bulgaria
      • Pleven, Bulgaria
      • Rousse, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
      • Saskatoon N/A, Canada
      • Winnipeg N/A, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Brandon, Manitoba, Canada
    • Ontario
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Croatia
      • Osijek, Croatia
      • Rijeka, Croatia
      • Zagreb, Croatia
  • France
      • Amiens Cedex 1, France
      • Bordeaux, France
      • Caen Cedex 9, France
      • Lille, France
      • Paris, France
      • Paris Cedex 18, France
      • Rouen, France
      • Vandoeuvre Les Nancy, France
  • Germany
      • Berlin, Germany
      • Bochum, Germany
      • Frankfurt, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Haßloch, Germany
      • Heidelberg, Germany
      • Kiel, Germany
      • Lÿneburg, Germany
      • Mannheim, Germany
      • Minden, Germany
      • München, Germany
      • Münster, Germany
      • Regensburg, Germany
      • Stade, Germany
      • Ulm, Germany
  • Hungary
      • Budapest, Hungary
      • Budapest N/A, Hungary
      • Békéscsaba, Hungary
      • Debrecen, Hungary
      • Gyula, Hungary
      • Mosonmagyaróvár, Hungary
      • Pecs, Hungary
      • Szekesfehervar, Hungary
      • Szekszard, Hungary
  • Iceland
      • Reykjavik, Iceland
  • Israel
      • Beer Yaakov, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petah Tikva, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
  • Japan
      • Chikushino, Japan
      • Hachioji, Japan
      • Hamamatsu, Japan
      • Hirosaki, Japan
      • Hiroshima, Japan
      • Kagoshima, Japan
      • Nishinomiya, Japan
      • Ohtsu, Japan
      • Oita, Japan
      • Osaka, Japan
      • Sakura, Japan
      • Sapporo, Japan
      • Sendai, Japan
      • Suita-Shi, Japan
      • Tokyo, Japan
      • Tsu, Japan
      • Uruma, Japan
      • Yokkaichi, Japan
      • Yokohama, Japan
      • Yokosuka, Japan
  • Korea, Republic of
      • Daegu, Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
      • Seoul, Korea, Republic of
  • Netherlands
      • Amsterdam, Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Grafton, New Zealand
      • Hamilton, New Zealand
      • Hastings, New Zealand
      • Plenty, New Zealand
      • Wellington, New Zealand
  • Poland
      • Bydgoszcz, Poland
      • Elblag, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Warszawa, Poland
  • Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Beograd, Serbia
  • South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Pretoria, South Africa
  • Spain
      • Madrid, Spain
      • Sabadell, Spain
      • Santiago De Compostela, Spain
  • United Kingdom
      • Birmingham, United Kingdom
      • Brighton, United Kingdom
      • Bristol, United Kingdom
      • Cambridge, United Kingdom
      • Gloucester, United Kingdom
      • Harrow, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
      • Nottinghamshirecc, United Kingdom
      • Oxford, United Kingdom
      • Shrewsbury, United Kingdom
      • Southampton, United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • San Diego, California, United States
      • Santa Monica, California, United States
      • Torrance, California, United States
    • Colorado
      • Lone Tree, Colorado, United States
    • Florida
      • Boca Raton, Florida, United States
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Largo, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • Port Orange, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Athens, Georgia, United States
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
      • Macon, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Iowa
      • Clive, Iowa, United States
    • Kansas
      • Pratt, Kansas, United States
      • Topeka, Kansas, United States
    • Kentucky
      • Crestview Hills, Kentucky, United States
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Houma, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Chevy Chase, Maryland, United States
      • Columbia, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Chesterfield, Michigan, United States
      • Novi, Michigan, United States
      • Troy, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
      • Ocean Springs, Mississippi, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
      • Lees Summit, Missouri, United States
      • Urbana, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Egg Harbor, New Jersey, United States
      • Marlton, New Jersey, United States
      • Morristown, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
      • Poughkeepsie, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Beavercreek, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Mentor, Ohio, United States
    • Oklahoma
      • Norman, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Malvern, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • North Charleston, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Grapevine, Texas, United States
      • Houston, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Chesapeake, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Bellevue, Washington, United States
      • Seattle, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
  • Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
  • Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
  • Have screening laboratory test results within protocol-specified parameters

Exclusion Criteria:

  • Patients who have had any kind of bowel resection within 6 months
  • Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
  • Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug
  • Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
  • Patients with a history of or ongoing chronic or recurrent infectious disease
  • Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo IV
Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
Drug: Group 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.
EXPERIMENTAL: Ustekinumab 130 milligram (mg)
Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
Drug: Group 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
EXPERIMENTAL: Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg)
Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg) 390 mg (weight > 55 kg and <= 85 kg) and 520 mg (weight > 85 kg).
Drug: Group 3: ustekinumab approximately 6 mg/kg
Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Response at Week 6
Time Frame: Week 6
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants in Clinical Remission at Week 8
Time Frame: Week 8
Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points.
Week 8
Number of Participants in Clinical Response at Week 8
Time Frame: Week 8
Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Week 8
Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6
Time Frame: Week 6
70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 6
Number of Participants With CDAI 70 Point Response at Week 3
Time Frame: Week 3
70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR018418
  • CNTO1275CRD3002 (OTHER: Janssen Research & Development, LLC)
  • 2010-022759-42 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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