Clinical Trial: An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

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

Official Title: A Phase 3, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of CNTO1959 (Guselkumab) in the Treatment of Subjects With Generalized Pustular Psoriasis or Er

Brief Summary: The purpose of this study is to examine descriptively the efficacy of CNTO 1959 in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Detailed Summary: This is a phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), open-label study evaluating the efficacy and safety of CNTO1959 (Guselkumab) in the treatment of participants with GPP or EP. Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 up to Week 52 participants who will be defined "Very much improved" or "Much improved" in Clinical Global Impression (CGI) will continue to receive guselkumab 50 mg every 8 weeks from Week 20 to the study end (Week 52). At each visit timing from Week 20, participants who will be defined "No change" or "Worsened" will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until Week 52. Participants who are "Minimally improved" will also receive guselkumab 100 mg only if investigator considers it necessary. Participants will primarily be assessed for the treatment success. Participants' safety will be monitored throughout the study.
Sponsor: Janssen Pharmaceutical K.K.

Current Primary Outcome: Percentage of Participants with Treatment Success at Week16 [ Time Frame: Week 16 ]

Treatment success is defined as "Very much improved", "Much improved" or "Minimally improved" in Clinical Global Impression (CGI) scale. The CGI scale is a brief clinician-rated instrument which has five categories (Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Worsened (5).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 and Over Time [ Time Frame: Baseline, Week 16, 28, 36, 48 and 52 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score less than (<) 6 indicates that psoriasis has small or no effect at all on participant's life. 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.
  • Percentage of Participants with Treatment Success Over Time [ Time Frame: Baseline and Every 4 weeks up to Week 52 ]
    Treatment success is defined as "Very much improved", "Much improved" or "Minimally improved" in Clinical Global Impression (CGI) scale. The CGI scale is a brief clinician-rated instrument which has five categories (Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Worsened (5).
  • Percentage of Participants With Investigator's global assessment (IGA) score of 0 or 1 at Week 16 and over time [ Time Frame: Week 16, 28, 36, 48 and 52 ]
    Investigator's global assessment (IGA) score is Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  • Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 and over time [ Time Frame: Week 16, 28, 36, 48 and 52 ]
    The Psoriasis Area and Severity Index (PASI) is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a total numeric score that can range from 0 to 72.
  • Change From Baseline in Total and Component Japanese Dermatological Association (JDA) Severity Index for Generalized Pustular Psoriasis (GPP) Over Time [ Time Frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52 ]
    Japanese Dermatological Association (JDA) severity index for GPP consists of area of etythema with pustules, area of erythema (total), area of edema, fever, white blood cells (WBC), high sensitivity C-reactive protein (hsCRP) and serum albumin. The total score of JDA severity index for GPP is assigned a score of 0-17 (0=best, 17=worst).
  • Change From Baseline in Components of the JDA Severity Index for GPP Over Time [ Time Frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52 ]
    Area of erythema with pustules, area of erythema (total), area of edema are rated as 0 to 3. Fever, WBC, hsCRP and serum albumin are rated as 0 to 2.
  • Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP Over Time [ Time Frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52 ]
    Area of erythema with pustules, area of erythema (total), area of edema are rated as 0 to 3. Fever, WBC, hsCRP and serum albumin are rated as 0 to 2.
  • Change From Baseline in Body Surface Area (BSA) of Involvement of Lesion for Erythrodermic Psoriasis (EP) Over Time [ Time Frame: Baseline, Week 1, 2, 4, 6, 8, 16, 28, 36, 48 and 52 ]
    Calculation of BSA involvement in dermatological lesion is used to measure disease severity and treatment responses for participants with EP.
  • Percentage of Participants with DLQI Score of 0 or 1 Over Time in Participants With Baseline DLQI More Than 1 [ Time Frame: Baseline, Week 8, 16, 28, 36, 48 and 52 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score less than (<) 6 indicates that psoriasis has small or no effect at all on participant's life. 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.
  • Percent

    Original Secondary Outcome: Same as current

    Information By: Janssen Pharmaceutical K.K.

    Dates:
    Date Received: January 16, 2015
    Date Started: January 19, 2015
    Date Completion: September 21, 2018
    Last Updated: March 7, 2017
    Last Verified: March 2017