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

Primary Purpose

Pyoderma Gangrenosum

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
adalimumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyoderma Gangrenosum focused on measuring Pyoderma Gangrenosum, Ulcer, Efficacy, Safety, Adalimumab, Humira®, Japan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nagoya City University Hospital /ID# 164510
  • Juntendo University Urayasu Hospital /ID# 164422
  • Fukuoka University Hospital /ID# 164416
  • Fukushima Medical University Hospital /ID# 164358
  • Gunma University Hospital /ID# 164464
  • Asahikawa Medical University Hospital /ID# 164589
  • Showa University Fujigaoka Hospital /ID# 164406
  • Mie University Hospital /ID# 164389
  • Tohoku University Hospital /ID# 164360
  • Shinshu University Hospital /ID# 164852
  • Nagasaki University Hospital /ID# 167604
  • University of the Ryukyus Hospital /ID# 164981
  • Hamamatsu University Hospital /ID# 165890
  • Tokushima University Hospital /ID# 164359
  • Teikyo University Hospital /ID# 165665
  • Tokyo Medical University Hospital /ID# 165810
  • Keio University Hospital /ID# 165680
  • Yamaguchi University Hospital /ID# 164562
  • Kansai Medical Univ Hosp /ID# 165802
  • Hokkaido University Hospital /ID# 164419

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change from Baseline in total number of active ulcers
The number of all active PG ulcers will be counted at the specified visits.
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.
Changes from Baseline in total ulcer area
The change in total ulcer area is assessed.
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.
Mean time to occurrence of a new PG ulcer(s)
Mean time to occurrence of a new PG ulcer(s) is assessed.
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.
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.
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.
Percentage change in target Pyoderma Gangrenosum (PG) ulcer area
The percentage change in target PG ulcer area is assessed.
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.
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.
Changes from baseline in the proportion of participants taking analgesics
Proportion of participants taking analgesics is assessed.
Velocities of healing
This is assessed from baseline.
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.
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.
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.
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.

Full Information

First Posted
October 12, 2017
Last Updated
March 5, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03311464
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyoderma Gangrenosum
Keywords
Pyoderma Gangrenosum, Ulcer, Efficacy, Safety, Adalimumab, Humira®, Japan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
Humira®
Intervention Description
Study drug will be administered subcutaneously.
Primary Outcome Measure Information:
Title
Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR)
Description
The participants will be assessed whether they meet target PGAR at Week 26 based on PGAR score.
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1
Description
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
Title
Mean time to occurrence of new PG ulcers
Description
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
Title
Change from Baseline in total number of active ulcers
Description
The number of all active PG ulcers will be counted at the specified visits.
Time Frame
Week 26
Title
Change from Baseline in Dermatology Life Quality Index (DLQI)
Description
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
Title
Changes from Baseline in total ulcer area
Description
The change in total ulcer area is assessed.
Time Frame
Week 6 and Week 26
Title
Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score
Description
The Investigator assesses the inflammation status of the target ulcer at the specified visits according to the scales.
Time Frame
Up to Week 26
Title
Mean time to occurrence of a new PG ulcer(s)
Description
Mean time to occurrence of a new PG ulcer(s) is assessed.
Time Frame
Up to Week 52
Title
Mean time to healing of target ulcer
Description
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
Title
Proportion of participants achieving healing per PGAR for the target ulcer
Description
The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Time Frame
Week 52
Title
Proportion of participants who have achieved target PGAR
Description
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
Title
Percentage change in target Pyoderma Gangrenosum (PG) ulcer area
Description
The percentage change in target PG ulcer area is assessed.
Time Frame
Up to Week 26
Title
Proportion of participants achieving PGA 0
Description
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
Title
Change from Baseline in Pain as measured by Numerical Rating Scale (NRS)
Description
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
Title
Changes from baseline in the proportion of participants taking analgesics
Description
Proportion of participants taking analgesics is assessed.
Time Frame
Week 6 and Week 26
Title
Velocities of healing
Description
This is assessed from baseline.
Time Frame
Up to Week 26
Title
Proportion of participants achieving ulcer healing as assessed by PGAR
Description
The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Time Frame
Week 6
Title
Proportion of participants achieving PGA 0 of all PG ulcers
Description
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
Title
Mean time to relapse of the target PG ulcer
Description
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
Title
Mean time to healing as defined by PGAR
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital /ID# 164510
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Juntendo University Urayasu Hospital /ID# 164422
City
Urayasu Shi
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Fukuoka University Hospital /ID# 164416
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Fukushima Medical University Hospital /ID# 164358
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gunma University Hospital /ID# 164464
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Asahikawa Medical University Hospital /ID# 164589
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Showa University Fujigaoka Hospital /ID# 164406
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
227-0043
Country
Japan
Facility Name
Mie University Hospital /ID# 164389
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Tohoku University Hospital /ID# 164360
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Shinshu University Hospital /ID# 164852
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
〒390-8621
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 167604
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
University of the Ryukyus Hospital /ID# 164981
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Hamamatsu University Hospital /ID# 165890
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokushima University Hospital /ID# 164359
City
Tokushima-shi
State/Province
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Teikyo University Hospital /ID# 165665
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8605
Country
Japan
Facility Name
Tokyo Medical University Hospital /ID# 165810
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Keio University Hospital /ID# 165680
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Yamaguchi University Hospital /ID# 164562
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
7558505
Country
Japan
Facility Name
Kansai Medical Univ Hosp /ID# 165802
City
Hirakata-shi, Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 164419
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/adalimumab_M16-119.pdf
Description
clinical study report synopsis

Learn more about this trial

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

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