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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Subcut

Brief 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 Summary: 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.
Sponsor: Janssen Pharmaceutical K.K.

Current Primary Outcome: Change from baseline in PPSI total score at Week 16. [ Time Frame: Baseline to Week 16 ]

The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in PPSI total score over time [ Time Frame: Baseline up to 24 weeks ]
    The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
  • Change from baseline in PPPASI total score [ Time Frame: Baseline up to 24 weeks ]
    The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 72, with higher scores indicating more severity.
  • Proportion of participants who achieve a PPPASI-50 [ Time Frame: Up to 24 weeks ]
    PPPASI-50 is at least 50% reduction in the PPPASI score.
  • Proportion of participants who achieve a PGA score of 1 or less [ Time Frame: Up to 24 weeks ]
    The Physician's Global Assessment (PGA) is used to determine the participant's overall palmoplantar pustulosis lesions, at a given time point. Scores can range from 0 (clear) to 5 (very severe).
  • Proportion of participants who achieve a PPPASI-75 [ Time Frame: Up to 24 weeks ]
    PPPASI-75 is at least 75% reduction in the PPPASI score.
  • Change from baseline in PA (each score) [ Time Frame: Baseline up to 24 weeks ]
    The Physician's Assessment (PA) is used to determine the participant's pustule, vesicle, and nail lesions at a given time point. Scores can range from 0 (clear) to 5 (very severe).
  • Change from baseline in Patient's VAS-PPP severity [ Time Frame: Baseline up to 24 weeks ]
    The Patient's Visual Analogue Scale (VAS) assessment of palmoplantar pustulosis severity will be recorded on a 10-cm VAS.
  • Change from baseline in Physician's VAS-PAO activity [ Time Frame: Baseline up to 24 weeks ]
    Physician's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity will be recorded on a 10-cm VAS.
  • Change from baseline in Patient's VAS-PAO activity and pain [ Time Frame: Baseline up to 24 weeks ]
    Patient's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain will be recorded on each 10-cm VAS.
  • Change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline up to 24 weeks ]
    The DLQI is a 10-item questionnaire that in addition to evaluating overall quality of life (QOL), can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
  • Change form baseline in SF-36 score [ Time Frame: Baseline up to 24 weeks ]
    The 36-Item Short Form Health Survey (SF-36) consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception.


Original Secondary Outcome: Same as current

Information By: Janssen Pharmaceutical K.K.

Dates:
Date Received: April 30, 2013
Date Started: June 2013
Date Completion:
Last Updated: October 26, 2015
Last Verified: October 2015