An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
- Sponsor
- Janssen Pharmaceutical K.K.
- Study ID
- NCT02641730
- Phase
- PHASE3
- Status
- Completed
Conditions
- Palmoplantar Pustulosis
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Guselkumab — DRUGParticipants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
- Placebo — DRUGParticipants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.
Study Details
The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.
Key Dates
- Start date
- Dec 15, 2015
- Status verified
- Jan 2025
- Primary completion
- Mar 28, 2017
- Completion
- Jul 17, 2018
Study Design
- Enrollment
- 159 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1Participants will receive guselkumab 200 milligram (mg) at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, and two syringes of placebo at Week 16 to maintain the blind.
- Experimental: Group 2Participants will receive a syringe of guselkumab 100 mg and a syringe of placebo for guselkumab at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, two syringes of placebo at Week 16 to maintain the blind.
- Experimental: Group 3Participants will receive two syringes of placebo at Week 0, 4 and 12. At Week 16, placebo participants will be randomized in a 1:1 ratio to guselkumab mg arm (Group 3a) or 100 mg arm (Group 3b). Group 3a participants will receive guselkumab 200 mg at Week 16, 20 and every 8 weeks thereafter through Week 60. Group 3b participants will receive guselkumab 100 mg and a syringe of placebo at Week 16, 20 and every 8 weeks thereafter through Week 60.
Primary Outcome Measure
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 [ Time Frame: Baseline and Week 16 ]
Related Studies
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- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar PustulosisPHASE3 · Recruiting · UCB Biopharma SRL · Columbus, Ohio