A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan

Sponsor
AbbVie
Study ID
NCT03311464
Phase
PHASE3
Status
Completed

Conditions

  • Pyoderma Gangrenosum

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — DRUG
    Study drug will be administered subcutaneously.

Study Details

This study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab in subjects in Japan with active ulcer(s) due to Pyoderma Gangrenosum (PG).

Key Dates

Start date
Oct 27, 2017
Status verified
Mar 2021
Primary completion
Aug 20, 2019
Completion
Apr 21, 2020

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).

Primary Outcome Measure

Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) [ Time Frame: Week 26 ]

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