NCT01845987

A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody, Following Subcutaneous Administration in Subjects With Palmoplantar Pustulosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.

Detailed description

This will be a double-blind (participants and study personnel will not know the identity of the treatments given), multicenter study that is placebo-controlled (a placebo is identical to a study treatment, but has no active ingredients). Participants will be randomly assigned to 1 of 2 treatment groups (CNTO 1959 or placebo). The total duration of participation will be approximately 30 weeks, including a screening period of about 6 weeks before dosing. Participant safety will be monitored throughout the study.

Conditions

• Palmoplantaris Pustulosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
DRUG	CNTO 1959	CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-05-03
• Last updated: 2015-11-20

Locations

8 sites across 1 country: Japan