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Phase 3 N=159 Randomized Double-blind Treatment

An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

Palmoplantar Pustulosis

Enrolled (actual)
159
Serious AEs
6.7%
Results posted
Feb 2019
Primary outcome: Primary: Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 — -7.79; -15.08; -11.07 Units on a scale — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Guselkumab (Drug); Placebo (Drug)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Janssen Pharmaceutical K.K.
Primary completion
Mar 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
-7.79; -15.08; -11.07 <0.001 sig
SECONDARY
Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16
-2.0; -3.9; -3.0
SECONDARY
Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16
34.0; 57.4; 36.5
SECONDARY
Change From Baseline in PPPASI Total Score
-3.58; -2.27; -3.02; -4.39; -6.43; -5.28
SECONDARY
Change From Baseline in PPSI Total Score
-0.5; -0.5; -0.6; -0.7; -1.5; -1.3
SECONDARY
Percentage of Participants Who Achieved a PPPASI-50 Response
1.9; 3.7; 1.9; 5.7; 9.3; 11.5
SECONDARY
Percentage of Participants Who Achieved a PPPASI-75 Response
0; 1.9; 0; 0; 1.9; 1.9
SECONDARY
Percentage of Participants Who Achieved a PPPASI-90 Response
0; 1.9; 0; 0; 1.9; 0
SECONDARY
Percentage of Participants Who Achieved a PPPASI-100 Response
0; 0; 0; 0; 0; 0
SECONDARY
Percentage of Participants Who Achieved a PPSI-50 Response
0; 1.9; 0; 0; 9.3; 5.8
SECONDARY
Percentage of Participants Who Achieved a PPSI-75 Response
0; 0; 0; 0; 0; 1.9
SECONDARY
Percentage of Participants Who Achieved a PPSI-90 Response
0; 0; 0; 0; 0; 0
SECONDARY
Percentage of Participants Who Achieved a PPSI-100 Response
0; 0; 0; 0; 0; 0
SECONDARY
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
0; 0; 0; 0; 0; 0
SECONDARY
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
0; 0; 0; 0; 0; 0
SECONDARY
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
0; 0; 0; 0; 0; 0
SECONDARY
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
-1.8; -5.0; -3.1; -4.3; -4.2; -5.2
SECONDARY
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
1.27; 4.67; 3.34; 5.46; 7.16; 8.31
SECONDARY
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
1.20; 0.64; 0.66; 2.19; 1.10; 0.52
SECONDARY
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
-0.1; 8.3; 8.5; 8.0; 6.5; 10.2

Summary

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

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02641730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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