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

Pyoderma Gangrenosum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311464
• Other study ID #: M16-119
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2017
• Est. completion date: April 21, 2020

Study information

• Verified date: March 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 21, 2020
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

Intervention

Drug:
• adalimumab
Study drug will be administered subcutaneously.

Locations

Country	Name	City	State
Japan	Asahikawa Medical University Hospital /ID# 164589	Asahikawa-shi	Hokkaido
Japan	Fukuoka University Hospital /ID# 164416	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 164358	Fukushima-shi	Fukushima
Japan	Hamamatsu University Hospital /ID# 165890	Hamamatsu-shi	Shizuoka
Japan	Kansai Medical Univ Hosp /ID# 165802	Hirakata-shi, Osaka
Japan	Teikyo University Hospital /ID# 165665	Itabashi-ku	Tokyo
Japan	Gunma University Hospital /ID# 164464	Maebashi-shi	Gunma
Japan	Shinshu University Hospital /ID# 164852	Matsumoto-shi	Nagano
Japan	Nagasaki University Hospital /ID# 167604	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital /ID# 164510	Nagoya-shi	Aichi
Japan	University of the Ryukyus Hospital /ID# 164981	Nakagami-gun	Okinawa
Japan	Hokkaido University Hospital /ID# 164419	Sapporo
Japan	Tohoku University Hospital /ID# 164360	Sendai-shi	Miyagi
Japan	Keio University Hospital /ID# 165680	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital /ID# 165810	Shinjuku-ku	Tokyo
Japan	Tokushima University Hospital /ID# 164359	Tokushima-shi	Tokushima
Japan	Mie University Hospital /ID# 164389	Tsu-shi	Mie
Japan	Yamaguchi University Hospital /ID# 164562	Ube-shi	Yamaguchi
Japan	Juntendo University Urayasu Hospital /ID# 164422	Urayasu Shi	Chiba
Japan	Showa University Fujigaoka Hospital /ID# 164406	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 26
Secondary	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.	Week 6 and Week 26
Secondary	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.	Up to Week 26
Secondary	Change from Baseline in total number of active ulcers	The number of all active PG ulcers will be counted at the specified visits.	Week 26
Secondary	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.	Week 6 and Week 26
Secondary	Changes from Baseline in total ulcer area	The change in total ulcer area is assessed.	Week 6 and Week 26
Secondary	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.	Up to Week 26
Secondary	Mean time to occurrence of a new PG ulcer(s)	Mean time to occurrence of a new PG ulcer(s) is assessed.	Up to Week 52
Secondary	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.	Up to Week 52
Secondary	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.	Week 52
Secondary	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.	Up to Week 26
Secondary	Percentage change in target Pyoderma Gangrenosum (PG) ulcer area	The percentage change in target PG ulcer area is assessed.	Up to Week 26
Secondary	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.	Week 6 and Week 26
Secondary	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.	Week 6 and Week 26
Secondary	Changes from baseline in the proportion of participants taking analgesics	Proportion of participants taking analgesics is assessed.	Week 6 and Week 26
Secondary	Velocities of healing	This is assessed from baseline.	Up to Week 26
Secondary	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.	Week 6
Secondary	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.	Week 52
Secondary	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.	Up to Week 26
Secondary	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.	Up to Week 26

External Links

•   clinical study report synopsis