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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Pyoderma Gangrenosum

Treatments: Drug: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03311464

M16-119

Details and patient eligibility

About

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).

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Arm A

Experimental group

Description:

Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).

Treatment:

Drug: adalimumab