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Monoclonal Antibodies

Ustekinumab 3 mg/kg (IP) for Crohn's Disease

Phase 2
Waitlist Available
Research Sponsored by Centocor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 22
Awards & highlights
All Individual Drugs Already Approved

Summary

A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Clinical Response at Week 6
Secondary study objectives
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)
Number of Participants With Clinical Remission at Week 6
Number of Participants With Clinical Remission at Week 8
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)Experimental Treatment1 Intervention
Group II: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)Experimental Treatment1 Intervention
Group III: Ustekinumab 6 mg/kg (IP)Experimental Treatment1 Intervention
Group IV: Ustekinumab 3 mg/kg (IP)Experimental Treatment1 Intervention
Group V: Ustekinumab 1mg/kg (IP)Experimental Treatment1 Intervention
Group VI: Ustekinumab IV - Nonresponder - Placebo SC (MP)Placebo Group1 Intervention
Group VII: Placebo (IP)Placebo Group1 Intervention
Group VIII: Placebo IV - Responder - Placebo SC (MP)Placebo Group1 Intervention
Group IX: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SCPlacebo Group1 Intervention
Group X: Ustekinumab IV - Responder - Placebo SC (MP)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
FDA approved
Ustekinumab
FDA approved
Ustekinumab
FDA approved
Ustekinumab
FDA approved
Ustekinumab
FDA approved

Find a Location

Who is running the clinical trial?

Centocor, Inc.Lead Sponsor
112 Previous Clinical Trials
43,023 Total Patients Enrolled
Centocor, Inc. Clinical TrialStudy DirectorCentocor, Inc.
72 Previous Clinical Trials
30,918 Total Patients Enrolled
~31 spots leftby Oct 2025
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