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Completed

NCT Number: NCT03311464

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

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Key information

Conditions

Pyoderma Gangrenosum Pathologic Processes Pathological Conditions, Signs and Symptoms Pyoderma Skin Diseases Skin Diseases, Vascular Skin Ulcer Skin and Connective Tissue Diseases Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya City University Hospital /ID# 164510, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adalimumab

Drug

Study drug will be administered subcutaneously.

Other names: Humira®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 17, 2017
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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