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

AbbVie22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pyoderma Gangrenosum

Interventions

adalimumabDRUG

Study drug will be administered subcutaneously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Nagoya City University Hospital /ID# 164510

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR)

The participants will be assessed whether they meet target PGAR at Week 26 based on PGAR score.

Time frame: Week 26

Secondary Outcomes

Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1

The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.

Time frame: Week 6 and Week 26

Mean time to occurrence of new PG ulcers

A new PG ulcer is defined as not present at Baseline and not caused by the epithelial bridging of an existing ulcer at Baseline. The time after Baseline when the new lesion was observed will be recorded.

Time frame: Up to Week 26

Change from Baseline in total number of active ulcers

The number of all active PG ulcers will be counted at the specified visits.

Time frame: Week 26

Change from Baseline in Dermatology Life Quality Index (DLQI)

The DLQI will be used to assess the symptoms and the impact of skin problems on quality of life.

Time frame: Week 6 and Week 26

Changes from Baseline in total ulcer area

The change in total ulcer area is assessed.

Time frame: Week 6 and Week 26

Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score

The Investigator assesses the inflammation status of the target ulcer at the specified visits according to the scales.

Data from ClinicalTrials.gov

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Juntendo University Urayasu Hospital /ID# 164422

Urayasu Shi, Chiba, Japan

Fukuoka University Hospital /ID# 164416

Fukuoka, Fukuoka, Japan

Fukushima Medical University Hospital /ID# 164358

Fukushima, Fukushima, Japan

Gunma University Hospital /ID# 164464

Maebashi, Gunma, Japan

Asahikawa Medical University Hospital /ID# 164589

Asahikawa-shi, Hokkaido, Japan

Showa University Fujigaoka Hospital /ID# 164406

Yokohama, Kanagawa, Japan

Mie University Hospital /ID# 164389

Tsu, Mie-ken, Japan

Tohoku University Hospital /ID# 164360

Sendai, Miyagi, Japan

Shinshu University Hospital /ID# 164852

Matsumoto-shi, Nagano, Japan

...and 10 more locations

Time frame: Up to Week 26

Mean time to occurrence of a new PG ulcer(s)

Mean time to occurrence of a new PG ulcer(s) is assessed.

Time frame: Up to Week 52

Mean time to healing of target ulcer

The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

Time frame: Up to Week 52

Proportion of participants achieving healing per PGAR for the target ulcer

The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

Time frame: Week 52

Proportion of participants who have achieved target PGAR

The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

Time frame: Up to Week 26

Percentage change in target Pyoderma Gangrenosum (PG) ulcer area

The percentage change in target PG ulcer area is assessed.

Time frame: Up to Week 26

Proportion of participants achieving PGA 0

The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.

Time frame: Week 6 and Week 26

Change from Baseline in Pain as measured by Numerical Rating Scale (NRS)

The Numerical Rating Scale of Pain sheet will be filled out in the office by participants at the designated visits.

Time frame: Week 6 and Week 26

Changes from baseline in the proportion of participants taking analgesics

Proportion of participants taking analgesics is assessed.

Time frame: Week 6 and Week 26

Velocities of healing

This is assessed from baseline.

Time frame: Up to Week 26

Proportion of participants achieving ulcer healing as assessed by PGAR

The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

Time frame: Week 6

Proportion of participants achieving PGA 0 of all PG ulcers

The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.

Time frame: Week 52

Mean time to relapse of the target PG ulcer

The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

Time frame: Up to Week 26

Mean time to healing as defined by PGAR

The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

Time frame: Up to Week 26