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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02343744
• Date of registration: 16/01/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Pharmaceutical K.K.
• Public title: An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
• Scientific 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 Erythrodermic Psoriasis
• Date of first enrolment: January 19, 2015
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02343744
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Janssen Pharmaceutical K.K., Japan Clinical Trial
• Affiliation: Janssen Pharmaceutical K.K.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis
(EP) at screening. A diagnosis of GPP must be classified on the basis of the criteria
for diagnosis of GPP by Japanese Dermatological Association (JDA)

- Have a history of plaque-type psoriasis if subjects have a diagnosis of EP

- Have an involved body surface area (BSA) of lesion greater than or equal to (>=) 80
percent (%) at baseline if subjects have a diagnosis of EP.

- Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or
history of previous treatment)

- Before the first administration of study drug, a woman must be either not of
childbearing potential or of childbearing potential and practicing a highly effective
methods of birth control, consistent with local regulations regarding the use of birth
control methods for subjects participating in clinical studies

Exclusion Criteria:

- Has a total score of JDA severity index for GPP >=14 at baseline if subjects have a
diagnosis of GPP

- Has a differential diagnosis of the erythroderma (exmaple (eg), erythroderma caused by
lymphoma or drug eruption) other than EP.

- Has refused hospitalization though the investigator needed hospitalization

- Has body mass index (BMI) less than (<) 18 kilogram per square meters (kg/m^2) or
meets the following modified criteria for cachexia.

- Has a BMI < 20 kg/m^2 and has lost more than 5% of their body weight in the previous
months, and 4 out of the following are present: a) decreased muscle strength b)
fatigue or reduced physical activity c) anorexia d) low muscle mass e) CRP greater
than (>) 7 mg/L 6) hemoglobin (Hb) <12 gram per deciliters (g/dL) f) serum albumin <
3.0 g/dL

- Has Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Grade 2 or higher
heart failure or CTCAE v.4 Grade 3 or higher kidney failure



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pustular Psoriasis

Intervention(s)

Drug: Guselkumab

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Psoriasis (PSO) Over Time [Time Frame: Baseline, Week 16, 28, 36 and 48]

Number of Participants With Guselkumab Antibodies [Time Frame: Baseline, Pre-dose on Week 4, 16, 28, 48 and 52]

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]

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]

Observed Serum Guselkumab Concentrations [Time Frame: Baseline, Pre-dose on Week 4, 8, 12, 16, 20, 24, 28, 36, 44, 48 and 52]

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]

Change From Baseline in Physical and Mental Component Summary Scores of SF-36 Over Time [Time Frame: Baseline, Week 16, 28, 36 and 48]

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]

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]

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]

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]

Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time [Time Frame: Baseline, Week 8, 16, 28, 36, 48 and 52]

Percentage of Participants with Treatment Success Over Time [Time Frame: Baseline and Every 4 weeks up to Week 52]

Secondary ID(s)

CR104128

CNTO1959PSO3005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors