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

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease Inflammatory Bowel Disease IBD Colitis	Drug: Group 3: ustekinumab approximately 6 mg/kg Drug: Group 1: Placebo Drug: Group 2 ustekinumab 130 mg	Phase 3


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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Ustekinumab

U.S. FDA Resources

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:

Clinical Response [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical remission [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Clinical improvement/response [ Time Frame: Study visits through Week 8 ] [ Designated as safety issue: No ]


Enrollment:	638
Study Start Date:	July 2011
Study Completion Date:	October 2014
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 001 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: 002 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: 003 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).

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).

Eligibility


Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369342

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Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators


Study Director:	Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC

More Information


Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT01369342 History of Changes
Other Study ID Numbers:	CR018418 CNTO1275CRD3002 2010-022759-42
Study First Received:	June 7, 2011
Last Updated:	November 23, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:


ustekinumab moderately to severely active Crohn's Disease Stelara IBD	colitis crohn UNITI Crohn's

Additional relevant MeSH terms:


Crohn Disease Colitis Intestinal Diseases Inflammatory Bowel Diseases Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Ustekinumab Dermatologic Agents

ClinicalTrials.gov processed this record on September 29, 2016