Clinical trial NCT02343744: An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
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 Erythrodermic Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pustular Psoriasis
Keywords: Generalized Pustular Psoriasis
Erythrodermic Psoriasis
Guselkumab
CNTO1959
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants with Treatment Success at Week16
timeFrame: Week 16
Secondary outcomes:
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 and Over Time
timeFrame: Baseline, Week 16, 28, 36, 48 and 52
measure: Percentage of Participants with Treatment Success Over Time
timeFrame: Baseline and Every 4 weeks up to Week 52
measure: Percentage of Participants With Investigator's global assessment (IGA) score of 0 or 1 at Week 16 and over time
timeFrame: Week 16, 28, 36, 48 and 52
measure: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 and over time
timeFrame: Week 16, 28, 36, 48 and 52
measure: Change From Baseline in Total and Component Japanese Dermatological Association (JDA) Severity Index for Generalized Pustular Psoriasis (GPP) Over Time
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52
measure: Change From Baseline in Components of the JDA Severity Index for GPP Over Time
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52
measure: Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP Over Time
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52
measure: Change From Baseline in Body Surface Area (BSA) of Involvement of Lesion for Erythrodermic Psoriasis (EP) Over Time
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 16, 28, 36, 48 and 52
measure: Percentage of Participants with DLQI Score of 0 or 1 Over Time in Participants With Baseline DLQI More Than 1
timeFrame: Baseline, Week 8, 16, 28, 36, 48 and 52
measure: Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time
timeFrame: Baseline, Week 8, 16, 28, 36, 48 and 52
measure: Change From Baseline in Physical and Mental Component Summary Scores of SF-36 Over Time
timeFrame: Baseline, Week 16, 28, 36 and 48
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Psoriasis (PSO) Over Time
timeFrame: Baseline, Week 16, 28, 36 and 48
measure: Observed Serum Guselkumab Concentrations
timeFrame: Baseline, Pre-dose on Week 4, 8, 12, 16, 20, 24, 28, 36, 44, 48 and 52
measure: Number of Participants With Guselkumab Antibodies
timeFrame: Baseline, Pre-dose on Week 4, 16, 28, 48 and 52
Other outcomes:
Locations:
city: Asahikawa
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Izumo
country: Japan
city: Kawasaki
country: Japan
city: Kita-Gun
country: Japan
city: Kochi
country: Japan
city: Kurume
country: Japan
city: Matsumoto
country: Japan
city: Miyagi
country: Japan
city: Morioka
country: Japan
city: Nagoya
country: Japan
city: Sapporo
country: Japan
city: Shimotsuke
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Tsukuba
country: Japan
city: Tsu
country: Japan
city: Ube
country: Japan
city: Yokosuka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: