Status:
COMPLETED
A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
Lead Sponsor:
AbbVie
Conditions:
Pyoderma Gangrenosum
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03311464
Start Date
October 27 2017
End Date
April 21 2020
Last Update
March 9 2021
Active Locations (20)
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1
Nagoya City University Hospital /ID# 164510
Nagoya, Aichi-ken, Japan, 467-8602
2
Juntendo University Urayasu Hospital /ID# 164422
Urayasu Shi, Chiba, Japan, 279-0021
3
Fukuoka University Hospital /ID# 164416
Fukuoka, Fukuoka, Japan, 814-0180
4
Fukushima Medical University Hospital /ID# 164358
Fukushima, Fukushima, Japan, 960-1295