An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

• Status: Completed
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.

Criteria

Inclusion Criteria:

• Has a diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis, concurrent extra-palmoplantar lesions) for at least 24 weeks before screening

• Has a >= 12 PPPASI total score at screening and at baseline

• Has a moderate or more severe pustules/vesicle on the palms or soles (>= 2 PPPASI severity score) at screening and baseline

• Has inadequate response to the treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or the phototherapy and/or systemic etretinate prior to or at screening. Inadequate response is defined as a case judged by the investigator

• Before the first administration of study drug, a woman must be either: Not of childbearing potential: premenarchal; postmenopausal or Of childbearing potential and practicing a highly effective method of birth control

Exclusion Criteria:

• Has a diagnosis of plaque-type psoriasis

• Has obvious improvement during screening (>= 5 PPPASI total score improvement during the screening)

• Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 12 weeks or a cardiac hospitalization within the last 12 weeks before screening

• Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before screening or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 12 weeks before screening)