Clinical trial NCT02641730: An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Palmoplantar Pustulosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Palmoplantar Pustulosis
Keywords: Guselkumab
CNTO 1959
Placebo
Palmoplantar Pustulosis
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 159
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a phase 3, randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), multicenter (when more than one hospital works on a medical research study) placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) study in participants with palmoplantar pustulosis. The study will consist of 3 phases: screening phase (up to 6 weeks), treatment period (week 0 - week 60) and observational period (up to week 84). Participants will be assigned to 1 of 3 treatment groups (200 milligram \[mg\] guselkumab, 100 mg guselkumab or placebo group) using a stratified block randomization method in a 1:1:1 ratio at Week 0 and Group III (placebo) participants will be allocated in a 1:1 ratio to 1 of 2 treatment groups at Week 16. Participants will primarily be assessed for change from baseline in Palmo-Plantar Pustular Area and Severity Index (PPPASI) total score at Week 16. Safety will be monitored throughout the study.

Eligibility 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)

Primary outcomes:
measure: Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in PPPASI Total Score
timeFrame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Change From Baseline in PPSI Total Score
timeFrame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPPASI-50 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPPASI-75 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPPASI-90 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPPASI-100 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPSI-50 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPSI-75 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPSI-90 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PPSI-100 Response
timeFrame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 72 and Week 84
measure: Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
timeFrame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
timeFrame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
timeFrame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline, Week 16, 32, 52, 72 and Week 84
measure: Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Week 16, 32, 52, 72 and Week 84
measure: Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
timeFrame: Baseline, Week 16, 32, 52, 72 and Week 84
measure: Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
timeFrame: Baseline, Week 16, 32, 52, 72 and Week 84
Other outcomes:
Locations:
city: Asahikawa
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Hachioji
country: Japan
city: Hokkaido
country: Japan
city: Ichikawa
country: Japan
city: Ichinomiya
country: Japan
city: Kahoku-District
country: Japan
city: Kanazawa
country: Japan
city: Kobe
country: Japan
city: Kochi
country: Japan
city: Kofu
country: Japan
city: Kumamoto-City
country: Japan
city: Kyoto
country: Japan
city: Matsumoto
country: Japan
city: Morioka
country: Japan
city: Nagasaki-shi
country: Japan
city: Nagoya
country: Japan
city: Osaka-Sayama
country: Japan
city: Osaka
country: Japan
city: Sagamihara
country: Japan
city: Saku
country: Japan
city: Shimotsuke
country: Japan
city: Suita-shi
country: Japan
city: Takamatsu
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Toon
country: Japan
city: Toyoake
country: Japan
city: Tsukuba
country: Japan
city: Tsu
country: Japan
city: Yokohama
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Terui T, Kobayashi S, Okubo Y, Murakami M, Zheng R, Morishima H, Goto R, Kimura T. Efficacy and Safety of Guselkumab in Japanese Patients With Palmoplantar Pustulosis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2019 Oct 1;155(10):1153-1161. doi: 10.1001/jamadermatol.2019.1394.