A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Janssen Inc.
- Study ID
- NCT01483599
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- CNTO 1959 (5 mg) — DRUGSubcutaneous (SC) injections
- CNTO 1959 (15 mg) — DRUGSC injections
- CNTO 1959 (50 mg) — DRUGSC injections
- CNTO 1959 (100 mg) — DRUGSC injections
- CNTO 1959 (200 mg) — DRUGSC injections
- Adalimumab — DRUGSC injections
- Placebo — DRUGSC injections
Study Details
The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.
Key Dates
- Start date
- Nov 10, 2011
- Status verified
- Jul 2017
- Primary completion
- Nov 27, 2012
- Completion
- Aug 5, 2013
Study Design
- Enrollment
- 293 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CNTO 1959 (5 mg)CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
- Experimental: CNTO 1959 (15 mg)CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
- Experimental: CNTO 1959 (50 mg)CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
- Experimental: CNTO 1959 (100 mg)CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
- Experimental: CNTO 1959 (200 mg)CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
- Active Comparator: Adalimumab (approved psoriasis dosing)Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.)
- Placebo Comparator: Placebo to CNTO 1959 (100 mg)Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
Primary Outcome Measure
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Birmingham | Alabama | - | - |
| - | Bakersfield | California | - | - |
| - | Los Angeles | California | - | - |
| - | Santa Monica | California | - | - |
| - | Ocala | Florida | - | - |
| - | Alpharetta | Georgia | - | - |
| - | Arlington Heights | Illinois | - | - |
| - | Skokie | Illinois | - | - |
| - | Indianapolis | Indiana | - | - |
| - | Louisville | Kentucky | - | - |
| - | Andover | Massachusetts | - | - |
| - | Boston | Massachusetts | - | - |
| - | St Louis | Missouri | - | - |
| - | Albuquerque | New Mexico | - | - |
| - | New York | New York | - | - |
| - | Portland | Oregon | - | - |
| - | Pittsburgh | Pennsylvania | - | - |
| - | Houston | Texas | - | - |
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