NCT01483599

A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis

A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO 1959 for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: Janssen Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	CNTO 1959 (5 mg)	Subcutaneous (SC) injections
DRUG	CNTO 1959 (15 mg)	SC injections
DRUG	CNTO 1959 (50 mg)	SC injections
DRUG	CNTO 1959 (100 mg)	SC injections
DRUG	CNTO 1959 (200 mg)	SC injections
DRUG	Adalimumab	SC injections
DRUG	Placebo	SC injections

Timeline

• Start date: 2011-11-10
• Primary completion: 2012-11-27
• Completion: 2013-08-05
• First posted: 2011-12-01
• Last updated: 2017-08-02
• Results posted: 2017-08-02

Locations

40 sites across 5 countries: United States, Belgium, Canada, Germany, Poland