NCT02343744

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Typical duration for phase_3

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

January 19, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2015

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

January 16, 2015

Last Update Submit

October 22, 2019

Conditions

Pustular Psoriasis

Keywords

Generalized Pustular PsoriasisErythrodermic PsoriasisGuselkumabCNTO1959

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with Treatment Success at Week16

    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).

    Week 16

Secondary Outcomes (14)

  • Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 and Over Time

    Baseline, Week 16, 28, 36, 48 and 52

  • Percentage of Participants with Treatment Success Over Time

    Baseline and Every 4 weeks up to Week 52

  • Percentage of Participants With Investigator's global assessment (IGA) score of 0 or 1 at Week 16 and over time

    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

    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

    Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52

  • +9 more secondary outcomes

Study Arms (1)

Guselkumab

EXPERIMENTAL

Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 through the study end (Week 52) participants who are 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 are defined "No change" or "Worsened" in CGI will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until the study end (Week 52). Participants who are defined "Minimally improved" in CGI will also receive guselkumab 100 mg only if the investigator considers that it is necessary.

Drug: Guselkumab

Interventions

GuselkumabDRUG

Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 through the study end (Week 52) participants who are 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 are defined "No change" or "Worsened" in CGI will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until the study end (Week 52). Participants who are defined "Minimally improved" in CGI will also receive guselkumab 100 mg only if the investigator considers that it is necessary.

Also known as: CNTO 1959
Guselkumab

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Asahikawa, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gifu, Japan

Location

Unknown Facility

Izumo, Japan

Location

Unknown Facility

Kawasaki, Japan

Location

Unknown Facility

Kita-Gun, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Kurume, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Morioka, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Shimotsuke, Japan

Location

Unknown Facility

Tokushima, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Tsu, Japan

Location

Unknown Facility

Tsukuba, Japan

Location

Unknown Facility

Ube, Japan

Location

Unknown Facility

Yokosuka, Japan

Location

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

January 19, 2015

Primary Completion

December 4, 2015

Study Completion

November 2, 2018

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

JP(20)