NCT02533375

Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not have an adequate response to their currently approved treatment.

Detailed description

This was a Phase 3, multicenter, open-label, single-arm study of adalimumab in Japanese participants with generalized pustular psoriasis (GPP). The study included a 30-day screening period, a 52-week treatment period, and a 70-day follow-up period. The dose regimen of adalimumab used in this study was 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.

Conditions

• Generalized Pustular Psoriasis (GPP)
• Adalimumab
• Japanese

Interventions

Type	Name	Description
DRUG	Adalimumab	Adalimumab pre-filled syringe, administered by subcutaneous injection

Timeline

• Start date: 2015-09-28
• Primary completion: 2016-09-15
• Completion: 2017-07-20
• First posted: 2015-08-26
• Last updated: 2019-01-14
• Results posted: 2019-01-14