A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg; Ustekinumab (CNTO 1275) 45 mg; Ustekinumab (CNTO 1275) 90 mg
Intervention description: Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264; Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264; Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to Severe Plaque-Type Psoriasis; interleukin 23; IL-12; interleukin-12; interleukin-23; CNTO1275; biologic; Psoriasis; CNTO 1275; IL23; interleukin 12; IL-23; IL12; ustekinumab

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plaque-type psoriasis diagnosed >= 6 months prior

          -  Plaque-type psoriasis covering at least 10% of total body surface areas

          -  Psoriasis area-and-severity index score of >=12 at screening and baseline

          -  Considered by treating dermatologist to be a candidate for phototherapy or systemic
             treatment of psoriasis

          -  Women of childbearing potential and all men must agree to use adequate birth control
             measures throughout the trials and for 12 months following the last injection of study
             agent

          -  Have no history of latent or active tuberculosis (TB)

        Exclusion Criteria:

          -  Currently have nonplaque forms of psoriasis or drug-induced psoriasis

          -  Women who are pregnant or nursing, or men and women planning pregnancy while enrolled
             in the study

          -  Patients who have used any therapeutic agent targeted at reducing IL-12 or IL-23

          -  Patients who have had a Bacillus Calmette-Guerin (BCG) vaccination within the previous
             12 months prior to screening

          -  Patients who have a history of chronic or recurrent infectious disease or who have or
             have had a serious infection requiring hospitalization or intravenous antibiotics
             within the previous 2 months prior to screening

          -  Patients who have or ever have had a nontuberculous mycobacterial infection or
             opportunistic infection

          -  Patients known to be infected with human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C

          -  Patients who have current signs or symptoms of severe, progressive, or uncontrolled
             renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,
             neurologic, cerebral, or psychiatric disease

          -  Patients with a malignancy or who have a history of malignancy (with the exception of
             certain skin cancers and pre-invasive cervical cancer)

          -  Patients participating in another trial using an investigational agent or procedure

          -  Systemic immunosuppressants within 4 weeks of the first administration of study agent