A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

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 - IMUNITI

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022760-12-DE

Enrollment

1310

Registered

2011-05-26

Start date

2011-09-13

Completion date

Unknown

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to severely active Crohn's disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Have received study agent at Week 0 in study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 CDAI score evaluation. 2. Be able to complete the Week 0 visit in study CNTO1275CRD3003 within 4 days of the Week 8 visit in study CNTO1275CRD3001 or CNTO1275CRD3002. At the discretion of the investigator, the window may be extended to 8 days to allow appropriate treatment and/or recovery of nonserious infections (eg, acute upper respiratory tract infection, simple urinary tract infection). 3. Be able and willing to adhere to the study visit schedule and comply with other protocol requirements 4. Be capable of providing informed consent, which must be obtained prior to any study-related procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1235 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria: 1. Had any of the following changes to their concomitant medications due to Crohn’s disease (ie, lack of efficacy) since Week 0 of studies CNTO1275CRD3001 and CNTO1275CRD3002 a. Increase in physician-prescribed daily dose of oral corticosteroids of more than 5 mg or more of prednisone (or equivalent increase in prednisone-equivalent dose of other corticosteroids), b. Initiation of oral budesonide or increase in daily dose c. Initiation of parenteral, and oral corticosteroids for Crohn’s disease, except for dose equivalent substitutions among oral corticosteroids d. Initiation or increased physician-prescribed daily dose of methotrexate (MTX), 6-MP, or azathioprine (AZA), except for dose equivalent substitutions 2. Initiated a protocol prohibited medication since Week 0 of studies CNTO1275CRD3001 and CNTO1275CRD3002: a. Immune suppressing immunomodulatory agents other than 6-MP/AZA or MTX (including but not limited to 6-TG, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil) b. Immunosuppressant biologic agents (including but not limited to TNF-antagonists, natalizumab, abatacept, commercial ustekinumab) c. Experimental Crohn’s disease medications (including but not limited to thalidomide, briakinumab, vedolizumab, traficet, AMG-827) 3. Underwent a Crohn’s disease related surgery since Week 0 of induction study CNTO1275CRD3001 or CNTO1275CRD3002. Seton placement and recent cutaneous and perianal abscesses which have been drained and adequately treated at least 3 weeks prior to receiving baseline study agent are not exclusionary provided that there is no anticipated need for any further surgery 4. Subjects from countries with high multidrug-resistant TB burden (eg, South Africa, Bulgaria, and the Russian Federation) diagnosed with latent TB during induction study CNTO1275CRD3001 or CNTO1275CRD3002, or any subject who has discontinued or is noncompliant with appropriate therapy for the treatment of latent TB. 5. Are diagnosed with any medical condition (or signs or symptoms thereof) which would have precluded enrollment in induction studies CNTO1275CRD3001 and CNTO1275CRD3002. This includes any lymphoproliferative disorder or malignancy (other than basal cell carcinoma of the skin), opportunistic or other significant infection, or other severe, progressive, or uncontrolled medical (eg renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, or autoimmune) or psychiatric disease, including recent significant instability in a previous condition. 6. Have signs and symptoms of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis. 7. Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study or within 20 weeks after the last dose of study agent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives are: - To evaluate clinical remission for the 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease induced into clinical response with ustekinumab in the induction studies, CNTO1275CRD3001 and CNTO1275CRD3002. - To evaluate the safety of 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease.;Secondary Objective: The secondary objectives are: - To evaluate the efficacy of ustekinumab in maintaining clinical response in subjects induced into clinical response. - To evaluate the efficacy of ustekinumab in maintaining clinical remission in subjects induced into clinical remission. - To evaluate the efficacy of ustekinumab in achieving corticosteroid free remission. To evaluate the pharmacokinetics, immunogenicity, and pharmacodynamics of Ustekinumab therapy, including changes in C-reactive protein (CRP), fecal calprotectin, fecal lactoferrin, and other pharmacodynamic biomarkers. - To evaluate the effect of ustekinumab on health related quality of life.;Primary end point(s): The primary endpoint analysis and the major secondary endpoint analyses will include only subjects in clinical response to ustekinumab at Week 8 from 1 of the induction studies (CNTO1275CRD3001 or CNTO1275CRD3002) who were randomized at Week 0 of this study into 1 of the maintenance regimens. The primary endpoint is clinical remission at Week 44, where clinical remission is defined as a CDAI score of < 150 points.;Timepoint(s) of evaluation of this end point: At week 44	—

Measure

Time frame

Main Objective: The primary objectives are: - To evaluate clinical remission for the 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease induced into clinical response with ustekinumab in the induction studies, CNTO1275CRD3001 and CNTO1275CRD3002. - To evaluate the safety of 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease.;Secondary Objective: The secondary objectives are: - To evaluate the efficacy of ustekinumab in maintaining clinical response in subjects induced into clinical response. - To evaluate the efficacy of ustekinumab in maintaining clinical remission in subjects induced into clinical remission. - To evaluate the efficacy of ustekinumab in achieving corticosteroid free remission. To evaluate the pharmacokinetics, immunogenicity, and pharmacodynamics of Ustekinumab therapy, including changes in C-reactive protein (CRP), fecal calprotectin, fecal lactoferrin, and other pharmacodynamic biomarkers. - To evaluate the effect of ustekinumab on health related quality of life.;Primary end point(s): The primary endpoint analysis and the major secondary endpoint analyses will include only subjects in clinical response to ustekinumab at Week 8 from 1 of the induction studies (CNTO1275CRD3001 or CNTO1275CRD3002) who were randomized at Week 0 of this study into 1 of the maintenance regimens. The primary endpoint is clinical remission at Week 44, where clinical remission is defined as a CDAI score of < 150 points.;Timepoint(s) of evaluation of this end point: At week 44

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Secondary

Measure	Time frame
Secondary end point(s): The major secondary endpoints in order of importance are: 1. Clinical response at Week 44. 2. Clinical remission at Week 44 among subjects in clinical remission to ustekinumab at Week 0. 3. Corticosteroid-free remission at Week 44. 4. Clinical remission at Week 44 in the subset of subjects who were refractory or intolerant to TNF-antagonist therapy (ie, subjects from induction study CNTO1275CRD3001).;Timepoint(s) of evaluation of this end point: At week 44	—

Measure

Time frame

Secondary end point(s): The major secondary endpoints in order of importance are: 1. Clinical response at Week 44. 2. Clinical remission at Week 44 among subjects in clinical remission to ustekinumab at Week 0. 3. Corticosteroid-free remission at Week 44. 4. Clinical remission at Week 44 in the subset of subjects who were refractory or intolerant to TNF-antagonist therapy (ie, subjects from induction study CNTO1275CRD3001).;Timepoint(s) of evaluation of this end point: At week 44

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Countries

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, European Union, Germany, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Russian Federation, Serbia, South Africa, Spain, United Kingdom, United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com+310715242166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026