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) — DRUG
    Subcutaneous (SC) injections
  • CNTO 1959 (15 mg) — DRUG
    SC injections
  • CNTO 1959 (50 mg) — DRUG
    SC injections
  • CNTO 1959 (100 mg) — DRUG
    SC injections
  • CNTO 1959 (200 mg) — DRUG
    SC injections
  • Adalimumab — DRUG
    SC injections
  • Placebo — DRUG
    SC 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)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-BakersfieldCalifornia--
-Los AngelesCalifornia--
-Santa MonicaCalifornia--
-OcalaFlorida--
-AlpharettaGeorgia--
-Arlington HeightsIllinois--
-SkokieIllinois--
-IndianapolisIndiana--
-LouisvilleKentucky--
-AndoverMassachusetts--
-BostonMassachusetts--
-St LouisMissouri--
-AlbuquerqueNew Mexico--
-New YorkNew York--
-PortlandOregon--
-PittsburghPennsylvania--
-HoustonTexas--

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