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

Condition(s) targeted: Crohn's Disease; Inflammatory Bowel Disease; IBD; Colitis

Intervention: Group 3: ustekinumab approximately 6 mg/kg (Drug); Group 1: Placebo (Drug); Group 2 ustekinumab 130 mg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

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.

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Response

Secondary outcome:

Clinical remission

Clinical improvement/response

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Adelaide, Australia; Recruiting

Cairns, Australia; Recruiting

Central Queensland M C, Australia; Recruiting

Concord, Australia; Recruiting

Fremantle, Australia; Recruiting

Garran, Australia; Recruiting

Liverpool, Australia; Recruiting

Malvern, Australia; Recruiting

Parkville, Australia; Recruiting

Brussel, Belgium; Recruiting

Leuven, Belgium; Recruiting

Goiás, Brazil; Recruiting

Porto Alegre, Brazil; Recruiting

Rio De Janeiro, Brazil; Recruiting

Santo André, Brazil; Withdrawn

Sao Paulo, Brazil; Not yet recruiting

São Paulo, Brazil; Not yet recruiting

Pleven, Bulgaria; Recruiting

Rousse, Bulgaria; Recruiting

Sofia, Bulgaria; Recruiting

Varna, Bulgaria; Recruiting

Montreal N/A, Canada; Not yet recruiting

Toronto, Canada; Withdrawn

Avenija Gojka Suska 6, Croatia; Recruiting

Osijek, Croatia; Recruiting

Rijeka, Croatia; Recruiting

Zagreb, Croatia; Recruiting

Amiens Cedex 1, France; Recruiting

Bordeaux, France; Recruiting

Caen Cedex 9, France; Recruiting

Paris, France; Recruiting

Vandoeuvre Les Nancy, France; Recruiting

Berlin, Germany; Recruiting

Bochum, Germany; Recruiting

Essen, Germany; Withdrawn

Frankfurt Am Main, Germany; Recruiting

Halle, Germany; Recruiting

Hamburg, Germany; Recruiting

Hannover, Germany; Recruiting

Haßloch, Germany; Recruiting

Heidelberg, Germany; Recruiting

Kiel, Germany; Recruiting

Lÿneburg, Germany; Recruiting

Mannheim, Germany; Recruiting

Minden, Germany; Recruiting

München, Germany; Recruiting

Münster, Germany; Recruiting

Oberhausen, Germany; Withdrawn

Regensburg, Germany; Recruiting

Stade, Germany; Recruiting

Ulm, Germany; Recruiting

Budapest, Hungary; Recruiting

Budapest N/A, Hungary; Recruiting

Békéscsaba, Hungary; Recruiting

Gyula, Hungary; Recruiting

Mosonmagyaróvár, Hungary; Recruiting

Pecs, Hungary; Recruiting

Szekesfehervar, Hungary; Recruiting

Szekesfehervar N/A, Hungary; Not yet recruiting

Szekszard, Hungary; Recruiting

Reykjavik, Iceland; Recruiting

Dublin, Ireland; Not yet recruiting

Beer Yaakov, Israel; Not yet recruiting

Haifa, Israel; Recruiting

Jerusalem, Israel; Recruiting

Kfar Saba, Israel; Recruiting

Petah Tikva, Israel; Recruiting

Rehovot, Israel; Recruiting

Tel Aviv, Israel; Recruiting

Chikushino, Japan; Recruiting

Hamamatsu, Japan; Recruiting

Kagoshima, Japan; Recruiting

Kagoshima-Shi, Japan; Recruiting

Nishinomiya, Japan; Recruiting

Ohtsu, Japan; Recruiting

Oita, Japan; Recruiting

Osaka, Japan; Recruiting

Osaka-City, Japan; Recruiting

Sakura, Japan; Recruiting

Sakura-Shi, Japan; Recruiting

Sapporo, Japan; Recruiting

Shinjuku, Japan; Recruiting

Tokyo, Japan; Recruiting

Yokkaichi, Japan; Recruiting

Yokkaichi-Shi, Japan; Recruiting

Daegu, Korea, Republic of; Recruiting

Gyeonggi-Do, Korea, Republic of; Recruiting

Seoul, Korea, Republic of; Recruiting

Amsterdam, Netherlands; Recruiting

Amsterdam Zuidoost, Netherlands; Recruiting

Maastricht, Netherlands; Recruiting

Rotterdam, Netherlands; Recruiting

Auckland, New Zealand; Withdrawn

Christchurch, New Zealand; Recruiting

Dunedin, New Zealand; Recruiting

Dunedin Otago, New Zealand; Not yet recruiting

Grafton, New Zealand; Recruiting

Hamilton, New Zealand; Recruiting

Hastings, New Zealand; Recruiting

Plenty, New Zealand; Recruiting

Wellington, New Zealand; Recruiting

Bydgoszcz, Poland; Recruiting

Elblag, Poland; Recruiting

Krakow, Poland; Withdrawn

Lodz, Poland; Recruiting

Poznan, Poland; Withdrawn

Warszawa, Poland; Recruiting

Wroclaw, Poland; Withdrawn

Kaluga, Russian Federation; Withdrawn

Moscow, Russian Federation; Recruiting

Nizhny Novgorod, Russian Federation; Withdrawn

Novosibirsk, Russian Federation; Recruiting

Saint Petersburg, Russian Federation; Withdrawn

Belgrade, Serbia; Recruiting

Beograd, Serbia; Recruiting

Benoni, South Africa; Withdrawn

Cape Town, South Africa; Recruiting

Cape Town N/A, South Africa; Not yet recruiting

Durban, South Africa; Recruiting

Johannesburg, South Africa; Withdrawn

Johannesburg N/A, South Africa; Not yet recruiting

Pretoria, South Africa; Recruiting

Madrid, Spain; Recruiting

Sabadell, Spain; Recruiting

Santiago De Compostela, Spain; Recruiting

Sevilla, Spain; Withdrawn

Birmingham, United Kingdom; Recruiting

Brighton, United Kingdom; Recruiting

Bristol, United Kingdom; Recruiting

Cambridge, United Kingdom; Recruiting

Gloucester, United Kingdom; Recruiting

Harrow, United Kingdom; Recruiting

Liverpool, United Kingdom; Recruiting

London, United Kingdom; Recruiting

Manchester, United Kingdom; Recruiting

Norwich, United Kingdom; Recruiting

Nottinghamshirecc, United Kingdom; Recruiting

Oxford, United Kingdom; Recruiting

Shrewsbury, United Kingdom; Recruiting

South Shields, United Kingdom; Withdrawn

Southampton, United Kingdom; Recruiting

Sy4, United Kingdom; Recruiting

Birmingham, Alabama, United States; Withdrawn

Calgary, Alberta, Canada; Recruiting

Edmonton, Alberta, Canada; Recruiting

Tucson, Arizona, United States; Recruiting

Little Rock, Arkansas, United States; Completed

Vancouver, British Columbia, Canada; Recruiting

La Jolla, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Orange, California, United States; Withdrawn

San Diego, California, United States; Recruiting

San Francisco, California, United States; Not yet recruiting

Torrance, California, United States; Completed

Lone Tree, Colorado, United States; Recruiting

Gainesville, Florida, United States; Recruiting

Jacksonville, Florida, United States; Recruiting

Naples, Florida, United States; Recruiting

Winter Park, Florida, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Decatur, Georgia, United States; Recruiting

Macon, Georgia, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Clive, Iowa, United States; Recruiting

Iowa City, Iowa, United States; Withdrawn

Pratt, Kansas, United States; Recruiting

Crestview Hills, Kentucky, United States; Recruiting

Lexington, Kentucky, United States; Recruiting

Baton Rouge, Louisiana, United States; Recruiting

New Orleans, Louisiana, United States; Recruiting

Brandon, Manitoba, Canada; Recruiting

Chevy Chase, Maryland, United States; Recruiting

Towson, Maryland, United States; Recruiting

Boston, Massachusetts, United States; Recruiting

Worcester, Massachusetts, United States; Recruiting

Ann Arbor, Michigan, United States; Recruiting

Chesterfield, Michigan, United States; Recruiting

Novi, Michigan, United States; Recruiting

Troy, Michigan, United States; Recruiting

Ypsilanti, Michigan, United States; Recruiting

Ocean Springs, Mississippi, United States; Recruiting

Kansas City, Missouri, United States; Completed

Lees Summit, Missouri, United States; Recruiting

Mexico, Missouri, United States; Recruiting

Saint Louis, Missouri, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

Saint John, New Brunswick, Canada; Withdrawn

Egg Harbor, New Jersey, United States; Recruiting

Marlton, New Jersey, United States; Recruiting

Morristown, New Jersey, United States; Completed

Brooklyn, New York, United States; Withdrawn

Great Neck, New York, United States; Recruiting

New York, New York, United States; Recruiting

Chapel Hill, North Carolina, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Raleigh, North Carolina, United States; Recruiting

Beavercreek, Ohio, United States; Completed

Cincinnati, Ohio, United States; Recruiting

Norman, Oklahoma, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Tulsa, Oklahoma, United States; Completed

Kingston, Ontario, Canada; Recruiting

London, Ontario, Canada; Not yet recruiting

Toronto, Ontario, Canada; Recruiting

Bend, Oregon, United States; Recruiting

Malvern, Pennsylvania, United States; Completed

Philadelphia, Pennsylvania, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Withdrawn

Montreal, Quebec, Canada; Recruiting

Saskatoon, Saskatchewan, Canada; Completed

North Charleston, South Carolina, United States; Recruiting

Germantown, Tennessee, United States; Completed

Nashville, Tennessee, United States; Recruiting

Austin, Texas, United States; Recruiting

Grapevine, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Tyler, Texas, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Chesapeake, Virginia, United States; Recruiting

Virginia Beach, Virginia, United States; Recruiting

Bellevue, Washington, United States; Completed

Seattle, Washington, United States; Recruiting

Madison, Wisconsin, United States; Recruiting

To learn how to participate in this trial please click here.

Starting date: July 2011
Last updated: January 17, 2013