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

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ClinicalTrials.gov Identifier: NCT03311464
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

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).

Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Drug: adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : April 21, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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




Primary Outcome Measures :
  1. Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) [ Time Frame: Week 26 ]
    The participants will be assessed whether they meet target PGAR at Week 26 based on PGAR score.


Secondary Outcome Measures :
  1. Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1 [ Time Frame: Week 6 and Week 26 ]
    The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.

  2. Mean time to occurrence of new PG ulcers [ Time Frame: Up to Week 26 ]
    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.

  3. Change from Baseline in total number of active ulcers [ Time Frame: Week 26 ]
    The number of all active PG ulcers will be counted at the specified visits.

  4. Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Week 6 and Week 26 ]
    The DLQI will be used to assess the symptoms and the impact of skin problems on quality of life.

  5. Changes from Baseline in total ulcer area [ Time Frame: Week 6 and Week 26 ]
    The change in total ulcer area is assessed.

  6. Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score [ Time Frame: Up to Week 26 ]
    The Investigator assesses the inflammation status of the target ulcer at the specified visits according to the scales.

  7. Mean time to occurrence of a new PG ulcer(s) [ Time Frame: Up to Week 52 ]
    Mean time to occurrence of a new PG ulcer(s) is assessed.

  8. Mean time to healing of target ulcer [ Time Frame: Up to Week 52 ]
    The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

  9. Proportion of participants achieving healing per PGAR for the target ulcer [ Time Frame: Week 52 ]
    The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

  10. Proportion of participants who have achieved target PGAR [ Time Frame: Up to Week 26 ]
    The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

  11. Percentage change in target Pyoderma Gangrenosum (PG) ulcer area [ Time Frame: Up to Week 26 ]
    The percentage change in target PG ulcer area is assessed.

  12. Proportion of participants achieving PGA 0 [ Time Frame: Week 6 and Week 26 ]
    The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.

  13. Change from Baseline in Pain as measured by Numerical Rating Scale (NRS) [ Time Frame: Week 6 and Week 26 ]
    The Numerical Rating Scale of Pain sheet will be filled out in the office by participants at the designated visits.

  14. Changes from baseline in the proportion of participants taking analgesics [ Time Frame: Week 6 and Week 26 ]
    Proportion of participants taking analgesics is assessed.

  15. Velocities of healing [ Time Frame: Up to Week 26 ]
    This is assessed from baseline.

  16. Proportion of participants achieving ulcer healing as assessed by PGAR [ Time Frame: Week 6 ]
    The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

  17. Proportion of participants achieving PGA 0 of all PG ulcers [ Time Frame: Week 52 ]
    The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.

  18. Mean time to relapse of the target PG ulcer [ Time Frame: Up to Week 26 ]
    The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.

  19. Mean time to healing as defined by PGAR [ Time Frame: Up to Week 26 ]
    The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311464


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03311464    
Other Study ID Numbers: M16-119
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
Pyoderma Gangrenosum
Ulcer
Efficacy
Safety
Adalimumab
Humira®
Japan
Additional relevant MeSH terms:
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Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents