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

September 30, 2020 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 Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main purpose of this study is to determine whether additional ustekinumab treatment is beneficial in patients with moderately to severely active Crohn's disease who initially had a clinical response to IV ustekinumab in one of the 2 initial induction studies (the CNTO1275CRD3001 ["UNITI-1"] or CNTO1275CRD3002 ["UNITI-2"] induction studies). The maintenance treatment will be injections in the skin (given subcutaneously, or "SC") of 90 mg ustekinumab either every 8 weeks or 12 weeks, and the effects (both the benefits and any side effects or adverse events) will be compared to SC placebo injections (otherwise identical except without ustekinumab). Patients who responded to IV ustekinumab in the UNITI-1 (NCT01369329) or UNITI-2 (NCT01369342) induction studies will be put into one of these 3 groups by chance (randomly, like rolling dice). The study will be double-blinded (so that neither patients nor study personnel know the identity of the assigned treatment). Patients who are randomized to either SC placebo or 90mg ustekinumab SC every 12 weeks who experience worsening in their Crohn's Disease symptoms (per the study loss of response criteria) will have their treatment adjusted so that they will instead start to receive 90mg ustekinumab SC every 8 weeks. All patients from the UNITI-1 or UNITI-2 studies (in addition to the patients described above who responded to IV ustekinumab) will be eligible to enter this study, provided the Week 8 visit in those trials was completed and study requirements are still met. Patients who are not in clinical response to IV placebo or ustekinumab in UNITI-1 or UNITI-2 will receive both IV and SC study agent at the first visit of this study (week 0). Patients previously receiving IV placebo will receive ustekinumab 130 mg IV at week 0 (and SC placebo), and patients previously receiving IV ustekinumab will receive 90 mg ustekinumab SC at week 0 (as well as IV placebo). If these patients are in clinical response 8 weeks later, they will receive 90 SC ustekinumab at that week8 visit, and will continue to receive Ustekinumab (every 8 weeks for participants not in response to IV Ustekinumab and every 12 weeks for participants not in response to IV Placebo) throughout the rest of the study (provided they otherwise remain eligible). Patients in clinical response to IV placebo induction dosing will continue to receive SC placebo. The main part of this study, also called the maintenance portion, will last 44 weeks. After week 44, all participants who are continuing to do well will be eligible to continue to receive study agent in the second part of the study, a long term extension where the study agent will continue to be administered up to week 252. Participants who discontinue study agent, either during the study, or after week 252, will be asked to return for a final safety follow-up visit 20 weeks after they last received study agent.

Patients in response to IV ustekinumab will be randomized to receive either placebo (Group 1), Ustekinumab 90 mg SC every 12 weeks (Group 2), or Ustekinumab 90mgSC every 8 weeks (Group 3). If patients in Groups 1 or 2 lose response, they will cross over to receive ustekinumab 90mg every 8 weeks. Other populations (nonresponders to prior IV ustekinumab or IV placebo) will receive ustekinumab at Week0 (either 90mg SC or 130mg IV, respectively) and continue SC ustekinumab if in response at Week 8, Placebo IV responders will continue to receive Placebo SC q4w.

Study Type

Interventional

Enrollment (Actual)

1282

Phase

  • 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
      • Bedford Park, Australia
      • Box Hill, Australia
      • Central Queensland M C, Australia
      • Concord, Australia
      • Garran, Australia
      • Liverpool, Australia
      • Malvern, Australia
      • Parkville, Australia
  • Austria
      • Innsbruck, Austria
      • Wien, Austria
  • Belgium
      • Brussel, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • Brazil
      • Goiânia, Brazil
      • Porto Alegre, Brazil
      • Rio de Janeiro, Brazil
      • São Paulo, Brazil
  • Bulgaria
      • Pleven, Bulgaria
      • Rousse, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
      • Winnipeg, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Brandon, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Croatia
      • Rijeka, Croatia
      • Zagreb, Croatia
  • Czechia
      • Hradec Kralove, Czechia
      • Usti nad Labem, Czechia
  • Denmark
      • Herlev, Denmark
      • Silkeborg, Denmark
  • France
      • Lille, France
      • Marseille, France
      • Paris, France
      • Pessac, France
      • Reims, France
      • Rouen, France
      • Toulouse, France
      • Vandoeuvre les Nancy, France
  • Germany
      • Berlin, Germany
      • Erlangen, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Haßloch, Germany
      • Heidelberg, Germany
      • Jena, Germany
      • Kiel, Germany
      • LÿNEBURG, Germany
      • Mannheim, Germany
      • München, Germany
      • Münster, Germany
      • Regensburg, Germany
      • Stade, Germany
      • Ulm, Germany
  • Hungary
      • Budapest, Hungary
      • Békéscsaba, Hungary
      • Debrecen, Hungary
      • Mosonmagyarovar, Hungary
      • Pecs, Hungary
      • Szekesfehervar, Hungary
      • Szeksz Rd N/a, Hungary
  • Iceland
      • Reykjavik, Iceland
  • Ireland
      • Dublin 9, Ireland
  • Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petah Tikva, Israel
      • Ramat-Gan, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
      • Zerifin, Israel
  • Japan
      • Chikushino, Japan
      • Fukuoka, 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
      • 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
  • Poland
      • Elblag, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Warszawa, Poland
  • Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Saint-Petersburg, Russian Federation
  • Serbia
      • Belgrade, Serbia
  • South Africa
      • Cape Town, South Africa
      • Cape Town Western Cape, South Africa
      • Pretoria, South Africa
      • Somerset West, South Africa
  • Spain
      • Madrid, Spain
  • United Kingdom
      • Birmingham, United Kingdom
      • Brighton, United Kingdom
      • Bristol, United Kingdom
      • Cambridge, United Kingdom
      • Cardiff, United Kingdom
      • Exeter, United Kingdom
      • Gloucester, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
      • Nottinghamshirecc, United Kingdom
      • Oxford, United Kingdom
      • Shropshire, United Kingdom
      • Southampton, United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • San Carlos, California, United States
      • San Diego, California, United States
      • Santa Monica, California, United States
    • Colorado
      • Lone Tree, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Florida
      • Boca Raton, Florida, United States
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Naples, Florida, United States
      • Weston, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
      • Macon, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Evanston, Illinois, United States
    • Iowa
      • Clive, Iowa, United States
    • Kansas
      • Pratt, Kansas, United States
    • Kentucky
      • Crestview Hills, Kentucky, United States
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Chevy Chase, 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
      • Detroit, 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
      • Lee's Summit, Missouri, United States
      • Urbana, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Marlton, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
      • Poughkeepsie, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Mentor, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • North Charleston, South Carolina, United States
    • Tennessee
      • 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
      • 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

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who received study agent at the start of study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:
  • Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002
  • Patients who started a protocol prohibited medication since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
  • Patients with protocol-specified changes to their concomitant medications due to Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 001
Participants who were responders to Intravenous (IV) infusion of ustekinumab induction will be randomized to receive a single dose of placebo subcutaneously (SC) every 4 weeks (q4w).
Drug: Placebo SC
Placebo will be administered subcutaneously.
Experimental: 002
Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 milligram (mg) SC every 12 weeks (q12w).
Drug: Ustekinumab 90 mg SC q12w
Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
Experimental: 003
Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 mg SC every 8 weeks (q8w).
Drug: Ustekinumab 90 mg SC q8w
Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.
Experimental: 004
Participants who were nonresponders to IV ustekinumab induction will receive a single dose of ustekinumab 90 mg SC and one placebo IV at week 0, if then respond will continue to receive one ustekinumab 90 mg SC q8w.
Drug: Ustekinumab 90 mg SC q8w
Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.
Drug: Placebo IV
Placebo will be administered as a single Intravenous infusion at week 0.
Experimental: 005
Participants who were nonresponders to IV placebo induction will receive a single dose of ustekinumab 130 mg IV and one placebo SC at week 0, if then respond will continue to receive one ustekinumab 90 mg SC at week 8 then q12w.
Drug: Placebo SC
Placebo will be administered subcutaneously.
Drug: Ustekinumab 90 mg SC q12w
Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
Drug: Ustekinumab 130 mg IV
Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.
Placebo Comparator: 006
Participants who were responders to IV placebo induction will receive one dose of placebo SC q4w.
Drug: Placebo SC
Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Remission at Week 44
Time Frame: Week 44
Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.
Week 44

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Response at Week 44
Time Frame: Week 44
Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. 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 CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Week 44
Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study
Time Frame: Week 44
Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to ustekinumab at week 0 of maintenance study.
Week 44
Number of Participants With Corticosteroid-free Remission at Week 44
Time Frame: Week 44
Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.
Week 44
Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy
Time Frame: Week 44
Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.
Week 44

Collaborators and Investigators

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

Sponsor

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 (Actual)

September 13, 2011

Primary Completion (Actual)

June 10, 2015

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR018421
  • CNTO1275CRD3003 (Other Identifier: Janssen Research & Development, LLC)
  • 2010-022760-12 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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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