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Monoclonal Antibodies

A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis

Phase 3
Waitlist Available
Research Sponsored by Centocor Research & Development, 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 week 40 to week 52
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved

Summary

The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.

Eligible Conditions
  • Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40 to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 to week 52 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 Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12
Secondary study objectives
Change in Dermatology Life Quality Index (DLQI) at Week 12
Psoriasis
Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group III: Ustekinumab 90 mgExperimental Treatment1 Intervention
Group II: Group II: Ustekinumab 45 mgExperimental Treatment1 Intervention
Group III: Group I: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
FDA approved
Ustekinumab
FDA approved

Find a Location

Who is running the clinical trial?

Centocor Research & Development, Inc.Lead Sponsor
4 Previous Clinical Trials
907 Total Patients Enrolled
1 Trials studying Psoriasis
766 Patients Enrolled for Psoriasis
Centocor, Inc. Clinical TrialStudy DirectorCentocor, Inc.
72 Previous Clinical Trials
30,214 Total Patients Enrolled
10 Trials studying Psoriasis
6,086 Patients Enrolled for Psoriasis
~60 spots leftby Jan 2026
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