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

NCT ID: NCT02343744

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-19
• Study Completion Date: 2018-11-02

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.

Conditions

Pustular Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guselkumab

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.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

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.

Interventions

Guselkumab

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.

Intervention Type: DRUG

Other Intervention Names

CNTO 1959

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Asahikawa, , Japan

Fukuoka, , Japan

Gifu, , Japan

Izumo, , Japan

Kawasaki, , Japan

Kita-Gun, , Japan

Kochi, , Japan

Kurume, , Japan

Matsumoto, , Japan

Miyagi, , Japan

Morioka, , Japan

Nagoya, , Japan

Sapporo, , Japan

Shimotsuke, , Japan

Tokushima, , Japan

Tokyo, , Japan

Tsu, , Japan

Tsukuba, , Japan

Ube, , Japan

Yokosuka, , Japan

Countries

Japan

Other Identifiers

CNTO1959PSO3005

Identifier Type: OTHER

Identifier Source: secondary_id

CR104128

Identifier Type: -

Identifier Source: org_study_id