World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03311464
Date of registration: 12/10/2017
Prospective Registration: Yes
Primary sponsor: AbbVie
Public title: A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
Scientific 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
Date of first enrolment: October 27, 2017
Target sample size: 22
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03311464
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     AbbVie Inc.
Address: 
Telephone:
Email:
Affiliation:  AbbVie
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Pyoderma Gangrenosum
Intervention(s)
Drug: adalimumab
Primary Outcome(s)
Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) [Time Frame: Week 26]
Secondary Outcome(s)
Change from Baseline in Dermatology Life Quality Index (DLQI) [Time Frame: Week 6 and Week 26]
Change from Baseline in Pain as measured by Numerical Rating Scale (NRS) [Time Frame: Week 6 and Week 26]
Change from Baseline in total number of active ulcers [Time Frame: Week 26]
Changes from baseline in the proportion of participants taking analgesics [Time Frame: Week 6 and Week 26]
Changes from Baseline in total ulcer area [Time Frame: Week 6 and Week 26]
Mean time to healing as defined by PGAR [Time Frame: Up to Week 26]
Mean time to healing of target ulcer [Time Frame: Up to Week 52]
Mean time to occurrence of a new PG ulcer(s) [Time Frame: Up to Week 52]
Mean time to occurrence of new PG ulcers [Time Frame: Up to Week 26]
Mean time to relapse of the target PG ulcer [Time Frame: Up to Week 26]
Percentage change in target Pyoderma Gangrenosum (PG) ulcer area [Time Frame: Up to Week 26]
Proportion of participants achieving healing per PGAR for the target ulcer [Time Frame: Week 52]
Proportion of participants achieving PGA 0 [Time Frame: Week 6 and Week 26]
Proportion of participants achieving PGA 0 of all PG ulcers [Time Frame: Week 52]
Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1 [Time Frame: Week 6 and Week 26]
Proportion of participants achieving ulcer healing as assessed by PGAR [Time Frame: Week 6]
Proportion of participants who have achieved target PGAR [Time Frame: Up to Week 26]
Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score [Time Frame: Up to Week 26]
Velocities of healing [Time Frame: Up to Week 26]
Secondary ID(s)
M16-119
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history