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

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

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 Overview

• Status: Completed
• Conditions: Pyoderma Gangrenosum
• Intervention / Treatment: Drug: adalimumab

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hirakata-shi, Osaka, Japan, 573-1191
    • Kansai Medical Univ Hosp /ID# 165802
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital /ID# 164419
  • Aichi
    • Nagoya-shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 164510
  • Chiba
    • Urayasu Shi, Chiba, Japan, 279-0021
      • Juntendo University Urayasu Hospital /ID# 164422
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital /ID# 164416
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 164358
  • Gunma
    • Maebashi-shi, Gunma, Japan, 371-8511
      • Gunma University Hospital /ID# 164464
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 078-8510
      • Asahikawa Medical University Hospital /ID# 164589
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 227-0043
      • Showa University Fujigaoka Hospital /ID# 164406
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 164389
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-8574
      • Tohoku University Hospital /ID# 164360
  • Nagano
    • Matsumoto-shi, Nagano, Japan, 〒390-8621
      • Shinshu University Hospital /ID# 164852
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital /ID# 167604
  • Okinawa
    • Nakagami-gun, Okinawa, Japan, 903-0215
      • University of the Ryukyus Hospital /ID# 164981
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital /ID# 165890
  • Tokushima
    • Tokushima-shi, Tokushima, Japan, 770-8503
      • Tokushima University Hospital /ID# 164359
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8605
      • Teikyo University Hospital /ID# 165665
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 165810
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital /ID# 165680
  • Yamaguchi
    • Ube-shi, Yamaguchi, Japan, 7558505
      • Yamaguchi University Hospital /ID# 164562

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): April 21, 2020

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Japan; Adalimumab; Ulcer; Humira®; Pyoderma Gangrenosum
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin Diseases, Vascular; Pyoderma; Pyoderma Gangrenosum; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: M16-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No