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

NCT ID: NCT01369355

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-13
• Study Completion Date: 2019-10-01

Brief Summary

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.

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.

Conditions

Crohn's Disease; Colitis; IBD; Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Placebo SC

Intervention Type: DRUG

Placebo will be administered subcutaneously.

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).

Group Type: EXPERIMENTAL

Ustekinumab 90 mg SC q12w

Intervention Type: DRUG

Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

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).

Group Type: EXPERIMENTAL

Ustekinumab 90 mg SC q8w

Intervention Type: DRUG

Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

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.

Group Type: EXPERIMENTAL

Placebo IV

Intervention Type: DRUG

Placebo will be administered as a single Intravenous infusion at week 0.

Ustekinumab 90 mg SC q8w

Intervention Type: DRUG

Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

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.

Group Type: EXPERIMENTAL

Placebo SC

Intervention Type: DRUG

Placebo will be administered subcutaneously.

Ustekinumab 130 mg IV

Intervention Type: DRUG

Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

Ustekinumab 90 mg SC q12w

Intervention Type: DRUG

Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

006

Participants who were responders to IV placebo induction will receive one dose of placebo SC q4w.

Group Type: PLACEBO_COMPARATOR

Placebo SC

Intervention Type: DRUG

Placebo will be administered subcutaneously.

Interventions

Placebo SC

Placebo will be administered subcutaneously.

Intervention Type: DRUG

Placebo IV

Placebo will be administered as a single Intravenous infusion at week 0.

Intervention Type: DRUG

Ustekinumab 90 mg SC q8w

Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

Intervention Type: DRUG

Ustekinumab 130 mg IV

Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

Intervention Type: DRUG

Ustekinumab 90 mg SC q12w

Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Tucson, Arizona, United States

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

Lone Tree, Colorado, United States

New Haven, Connecticut, United States

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

Atlanta, Georgia, United States

Decatur, Georgia, United States

Macon, Georgia, United States

Idaho Falls, Idaho, United States

Chicago, Illinois, United States

Evanston, Illinois, United States

Clive, Iowa, United States

Pratt, Kansas, United States

Crestview Hills, Kentucky, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Baton Rouge, Louisiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Chevy Chase, Maryland, United States

Towson, Maryland, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Ann Arbor, Michigan, United States

Chesterfield, Michigan, United States

Detroit, Michigan, United States

Troy, Michigan, United States

Ypsilanti, Michigan, United States

Rochester, Minnesota, United States

Jackson, Mississippi, United States

Ocean Springs, Mississippi, United States

Columbia, Missouri, United States

Lee's Summit, Missouri, United States

Urbana, Missouri, United States

Las Vegas, Nevada, United States

Lebanon, New Hampshire, United States

Marlton, New Jersey, United States

Great Neck, New York, United States

New York, New York, United States

Poughkeepsie, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Mentor, Ohio, United States

Oklahoma City, Oklahoma, United States

Bend, Oregon, United States

Portland, Oregon, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Charleston, South Carolina, United States

Columbia, South Carolina, United States

North Charleston, South Carolina, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Grapevine, Texas, United States

Houston, Texas, United States

Tyler, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Chesapeake, Virginia, United States

Virginia Beach, Virginia, United States

Seattle, Washington, United States

Madison, Wisconsin, United States

Adelaide, , Australia

Bedford Park, , Australia

Box Hill, , Australia

Central Queensland M C, , Australia

Concord, , Australia

Garran, , Australia

Liverpool, , Australia

Malvern, , Australia

Parkville, , Australia

Innsbruck, , Austria

Vienna, , Austria

Brussels, , Belgium

Leuven, , Belgium

Liège, , Belgium

Goiânia, , Brazil

Porto Alegre, , Brazil

Rio de Janeiro, , Brazil

São Paulo, , Brazil

Pleven, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Brandon, Manitoba, Canada

Winnipeg, Manitoba, Canada

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

London, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Saskatoon, Saskatchewan, Canada

Rijeka, , Croatia

Zagreb, , Croatia

Hradec Králové, , Czechia

Ústí nad Labem, , Czechia

Herlev, , Denmark

Silkeborg, , Denmark

Lille, , France

Marseille, , France

Paris, , France

Pessac, , France

Reims, , France

Rouen, , France

Toulouse, , France

Vandœuvre-lès-Nancy, , France

Berlin, , Germany

Erlangen, , Germany

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Halle, , Germany

Hamburg, , Germany

Hanover, , Germany

Haßloch, , Germany

Heidelberg, , Germany

Jena, , Germany

Kiel, , Germany

LÿNEBURG, , Germany

Mannheim, , Germany

München, , Germany

Münster, , Germany

Regensburg, , Germany

Stade, , Germany

Ulm, , Germany

Békéscsaba, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Mosonmagyaróvár, , Hungary

Pécs, , Hungary

Szeksz Rd N/a, , Hungary

Székesfehérvár, , Hungary

Reykjavik, , Iceland

Dublin, , Ireland

Jerusalem, , Israel

Kfar Saba, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Rehovot, , Israel

Tel Aviv, , Israel

Tzrifin, , Israel

Chikushino-shi, , Japan

Fukuoka, , Japan

Hachiōji, , Japan

Hamamatsu, , Japan

Hirosaki, , Japan

Hiroshima, , Japan

Kagoshima, , Japan

Nishinomiya, , Japan

Ohtsu, , Japan

Osaka, , Japan

Ōita, , Japan

Sakura, , Japan

Sapporo, , Japan

Sendai, , Japan

Suita-shi, , Japan

Tokyo, , Japan

Tsu, , Japan

Uruma, , Japan

Yokkaichi, , Japan

Yokohama, , Japan

Yokosuka, , Japan

Amsterdam, , Netherlands

Maastricht, , Netherlands

Rotterdam, , Netherlands

Auckland, , New Zealand

Christchurch, , New Zealand

Dunedin, , New Zealand

Grafton, , New Zealand

Hamilton, , New Zealand

Hastings, , New Zealand

Plenty, , New Zealand

Elblag, , Poland

Krakow, , Poland

Lodz, , Poland

Warsaw, , Poland

Moscow, , Russia

Novosibirsk, , Russia

Saint Petersburg, , Russia

Belgrade, , Serbia

Cape Town, , South Africa

Cape Town Western Cape, , South Africa

Pretoria, , South Africa

Somerset West, , South Africa

Daegu, , South Korea

Gyeonggi-do, , South Korea

Seoul, , South Korea

Madrid, , Spain

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

Countries

United States; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; Croatia; Czechia; Denmark; France; Germany; Hungary; Iceland; Ireland; Israel; Japan; Netherlands; New Zealand; Poland; Russia; Serbia; South Africa; South Korea; Spain; United Kingdom

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Other Identifiers

CNTO1275CRD3003

Identifier Type: OTHER

Identifier Source: secondary_id

2010-022760-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR018421

Identifier Type: -

Identifier Source: org_study_id