Clinical Trial: A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Randomized, Open-Label Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With General

Brief Summary: The purpose of this study are to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome:

• Subjects with Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 [ Time Frame: Week 16 ]
  GPP Clinical Response, defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP.
• Subjects with Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 [ Time Frame: Week 16 ]
  EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP.

Original Primary Outcome:

• Subjects with Generalized Pustular Psoriasis (GPP) Achieving Clinical Response at Week 16 [ Time Frame: Week 16 ]
• Subjects with Erythrodermic Psoriasis (EP) Achieving Clinical Response at Week 16 [ Time Frame: Week 16 ]

Current Secondary Outcome:

• Subjects With GPP Achieving GPP Clinical Response at Week 52 [ Time Frame: Week 52 ]
  GPP Clinical Response, defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP.
• Subjects with GPP Achieving >= 90% Reduction from Baseline Psoriasis Area Severity Index (PASI) score (PASI 90) at Week 16 [ Time Frame: Week 16 ]
  The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
• Subjects with GPP Achieving PASI 90 at Week 52 [ Time Frame: Week 52 ]
  The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
• Subjects with EP Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ]
  EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP.
• Subjects with EP Achieving PASI 90 at Week 16 [ Time Frame: Week 16 ]
  The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
• Subjects with EP Achieving PASI 90 at Week 52 [ Time Frame: Week 52 ]
  The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.

Original Secondary Outcome:

• Subjects With GPP Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ]
• Subjects with GPP Achieving >= 90% Reduction from Baseline Psoriasis Area Severity Index (PASI) score (PASI 90) at Week 16 [ Time Frame: Week 16 ]
• Subjects with GPP Achieving PASI 90 at Week 52 [ Time Frame: Week 52 ]
• Subjects with EP Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ]
• Subjects with EP Achieving PASI 90 at Week 16 [ Time Frame: Week 16 ]
• Subjects with EP Achieving PASI 90 at Week 52 [ Time Frame: Week 52 ]

Dates:
Date Received: January 13, 2017
Date Started: January 26, 2017
Date Completion: October 5, 2021
Last Updated: April 28, 2017
Last Verified: April 2017