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

A Phase 3 Multicenter, Open-Label, Single Arm Study of the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Subjects in Japan

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).

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.