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

• Status: Completed
• Trial end date: 2020-04-21
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Participant must be able and willing to provide written informed consent. If the participant is < 20 years old, a parent or legal guardian must be willing to give written informed consent

• Participants must have a diagnosis of ulcerative (classic) PG made by the Investigator

• Participants must have demonstrated an inadequate response to conventional PG therapy or in the opinion of the Investigator they are not a suitable candidate for conventional PG treatment.

Exclusion Criteria:

• Participants with pustular, bullous/atypical, or vegetative variants of PG

• Participants with clinical evidence of ulceration that is non-PG related, vasculitis, thrombosisprone conditions, or monoclonal gammopathy

• Participants with a histopathological finding that is consistent with a diagnosis other than PG

• Participants receiving a therapeutic dose of prednisolone

• Participants with prior exposure to adalimumab or previous participation in an adalimumab clinical study.