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

Conditions

• Pustular Psoriasis

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Guselkumab — 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.

Study Details

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).

Key Dates

Start date

Jan 19, 2015

Status verified

Oct 2019

Primary completion

Dec 4, 2015

Completion

Nov 2, 2018

Study Design

Enrollment

21 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

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