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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• 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.
• 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]

Mean time to relapse of the target PG ulcer [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]

Changes from Baseline in total ulcer area [Time Frame: Week 6 and Week 26]

Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1 [Time Frame: Week 6 and Week 26]

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

Proportion of participants achieving PGA 0 [Time Frame: Week 6 and Week 26]

Proportion of participants achieving healing per PGAR for the target ulcer [Time Frame: Week 52]

Changes from baseline in the proportion of participants taking analgesics [Time Frame: Week 6 and Week 26]

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

Proportion of participants achieving PGA 0 of all PG ulcers [Time Frame: Week 52]

Mean time to healing as defined by PGAR [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 ulcer healing as assessed by PGAR [Time Frame: Week 6]

Change from Baseline in Pain as measured by Numerical Rating Scale (NRS) [Time Frame: Week 6 and Week 26]

Proportion of participants who have achieved target PGAR [Time Frame: Up to Week 26]

Change from Baseline in total number of active ulcers [Time Frame: Week 26]

Mean time to healing of target ulcer [Time Frame: Up to Week 52]

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