Clinical Trial: Palmoplantar Pustular Psoriasis Efficacy and Safety wIth Secukinumab

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psori

Brief Summary: Was to demonstrate superiority of secukinumab compared to placebo in patients with moderate to severe chronic palmoplantar pustular psoriasis with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) [ Time Frame: Baseline to Week 16 ]

Primary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who archieve a 75% reduction in ppPASI score from Baseline to Week 16 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • palmoplantar pustulosis Psoriasis Area and Severity Index response rate (ppPASI) [ Time Frame: Baseline to Week 16 ]
    A secondary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
  • palmoplantar pustulosis Psoriasis Area and Severity Index response rate (ppPASI) [ Time Frame: Baseline to Week 52 ]
    A secondary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 52 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
  • patient's safety [ Time Frame: Baseline to Week 60 ]
    Clinical safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, electrocardiograms (ECGs), and adverse events monitoring are measured as number of events


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: December 8, 2013
Date Started: December 2013
Date Completion: June 2017
Last Updated: September 23, 2016
Last Verified: September 2016