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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01369355
First received: June 7, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Colitis
IBD
Inflammatory Bowel Disease
Drug: Placebo
Drug: Ustekinumab
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 Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical remission [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission in patient subgroups such as those in remission at Week 0 or those who previously failed TNF-antagonists (ie, patients entering from study CNTO1275CRD3001) [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]
  • Corticosteroid-free remission [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1310
Study Start Date: September 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 001

Placebo Responders to ustekinumab:

Form=solution for injection route=Subcutaneous use. One SC injection q4w

Drug: Placebo

Responders to ustekinumab:

Form=solution for injection, route=Subcutaneous use. One SC injection q4w

Experimental: 002

Ustekinumab Responders to ustekinumab:

Form=solution for injection route=Subcutaneous use. One SC injection q12w

Drug: Ustekinumab

Responders to ustekinumab:

Form=solution for injection, route=Subcutaneous use. One SC injection q12w

Experimental: 003
Ustekinumab Responders to ustekinumab: type=1 unit=mg number=90 form=solution for injection route=Subcutaneous use. One SC injection q8w
Drug: Ustekinumab
Responders to ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection q8w
Experimental: 004
Ustekinumab Nonresponders to IV induction ustekinumab: type=1 unit=mg number=90 form=solution for injection route=Subcutaneous use. One SC injection at Week 0 if then respond one SC injection q8w
Drug: Ustekinumab
Nonresponders to IV induction ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection at Week 0
Experimental: 005
Ustekinumab Nonresponders to IV placebo: type=1 unit=mg number=130 form=solution for injection route=Intravenous use. One IV administration at Week 0 if then respond one SC injection ustekinumab 90 mg at Week 8 and then q12w
Drug: Ustekinumab
if then respond, one SC injection q8w

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 or UNITI-2 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 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 patients 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 for (up to) 3 additional years. Patients who discontinue study agent, either during the study, or after the full 4 years, 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 Week8

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369355

  Show 249 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01369355     History of Changes
Other Study ID Numbers: CR018421, CNTO1275CRD3003, 2010-022760-12
Study First Received: June 7, 2011
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Ustekinumab
Stelara, Moderately to severely active Crohn's Disease
IBD, Crohn's
UNITI
colitis
IL-12
IL-23

Additional relevant MeSH terms:
Colitis
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014