palmoplantar pustulosis
Conditions
Interventions
investigational material(s)
Generic name etc : Guselkumab
INN of investigational material :
Therapeutic category code : 269 Other agents for epidermis
Dosage and Administration for Investigational ma
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has a diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis, concurrent extrapalmoplantar 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
Exclusion criteria: - Has a diagnosis of plaquetypepsoriasis - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Palmo-Plantar Area and Severity Index (PPPASI) Total Score at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Palmo-Planter Severity Index (PPSI) Total Score at Week 16 Percentage of Participants who achieve a PPPASI50 at Week 16 | — |
Outcome results
None listed