NCT02904902

Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).

Detailed description

Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were completed in the Western countries and market authorization of adalimumab was approved in United States (US) and European Union (EU) for the treatment of subjects with HS. The differences between this study and global studies include sample size, study design, duration, and race.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	adalimumab	Subcutaneous Injection

Timeline

• Start date: 2016-09-06
• Primary completion: 2017-09-01
• Completion: 2019-05-30
• First posted: 2016-09-19
• Last updated: 2020-05-12
• Results posted: 2019-02-27

Locations

8 sites across 1 country: Japan