Clinical trial NCT03311464: A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
Ulcer
Efficacy
Safety
Adalimumab
Humira®
Japan
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR)
timeFrame: Week 26
Secondary outcomes:
measure: Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1
timeFrame: Week 6 and Week 26
measure: Mean time to occurrence of new PG ulcers
timeFrame: Up to Week 26
measure: Change from Baseline in total number of active ulcers
timeFrame: Week 26
measure: Change from Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Week 6 and Week 26
measure: Changes from Baseline in total ulcer area
timeFrame: Week 6 and Week 26
measure: Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score
timeFrame: Up to Week 26
measure: Mean time to occurrence of a new PG ulcer(s)
timeFrame: Up to Week 52
measure: Mean time to healing of target ulcer
timeFrame: Up to Week 52
measure: Proportion of participants achieving healing per PGAR for the target ulcer
timeFrame: Week 52
measure: Proportion of participants who have achieved target PGAR
timeFrame: Up to Week 26
measure: Percentage change in target Pyoderma Gangrenosum (PG) ulcer area
timeFrame: Up to Week 26
measure: Proportion of participants achieving PGA 0
timeFrame: Week 6 and Week 26
measure: Change from Baseline in Pain as measured by Numerical Rating Scale (NRS)
timeFrame: Week 6 and Week 26
measure: Changes from baseline in the proportion of participants taking analgesics
timeFrame: Week 6 and Week 26
measure: Velocities of healing
timeFrame: Up to Week 26
measure: Proportion of participants achieving ulcer healing as assessed by PGAR
timeFrame: Week 6
measure: Proportion of participants achieving PGA 0 of all PG ulcers
timeFrame: Week 52
measure: Mean time to relapse of the target PG ulcer
timeFrame: Up to Week 26
measure: Mean time to healing as defined by PGAR
timeFrame: Up to Week 26
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital /ID# 164510
state: Aichi
city: Urayasu Shi
country: Japan
facility: Juntendo University Urayasu Hospital /ID# 164422
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 164416
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 164358
state: Fukushima
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 164464
state: Gunma
city: Asahikawa-shi
country: Japan
facility: Asahikawa Medical University Hospital /ID# 164589
state: Hokkaido
city: Yokohama-shi
country: Japan
facility: Showa University Fujigaoka Hospital /ID# 164406
state: Kanagawa
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 164389
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 164360
state: Miyagi
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital /ID# 164852
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 167604
state: Nagasaki
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 164981
state: Okinawa
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 165890
state: Shizuoka
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital /ID# 164359
state: Tokushima
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital /ID# 165665
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 165810
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 165680
state: Tokyo
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital /ID# 164562
state: Yamaguchi
city: Hirakata-shi, Osaka
country: Japan
facility: Kansai Medical Univ Hosp /ID# 165802
city: Sapporo
country: Japan
facility: Hokkaido University Hospital /ID# 164419
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: