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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Pyoderma Gangrenosum

Intervention / Treatment
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* Drug: adalimumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s). | Drug: adalimumab<br>* Study drug will be administered subcutaneously.<br>* Other names: Humira®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Week 6 and Week 26 | 
| Changes from Baseline in total ulcer area | The change in total ulcer area is assessed. | 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. | 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. | 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. | 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. | 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. | Up to Week 26 | 
| Percentage change in target Pyoderma Gangrenosum (PG) ulcer area | The percentage change in target PG ulcer area is assessed. | 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. | 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. | Week 6 and Week 26 | 
| Changes from baseline in the proportion of participants taking analgesics | Proportion of participants taking analgesics is assessed. | Week 6 and Week 26 | 
| Velocities of healing | This is assessed from baseline. | 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. | 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. | 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. | 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. | Up to Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pyoderma Gangrenosum, Ulcer, Efficacy, Safety, Adalimumab, Humira®, Japan