An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis (NCT02641730) | Clinical Trial Compass
CompletedPhase 3
An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
Japan159 participantsStarted 2015-12-15
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mal…
What they're measuring
1
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16