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

NCT03311464 | Completed Phase 3

• 1 other identifier: M16-119
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 20

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).

Conditions

Pyoderma Gangrenosum

Keywords

Pyoderma Gangrenosum; Ulcer; Efficacy; Safety; Adalimumab; Humira®; Japan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1

  Week 6 and Week 26

• Mean time to occurrence of new PG ulcers

  Up to Week 26

• Change from Baseline in total number of active ulcers

  Week 26

• Change from Baseline in Dermatology Life Quality Index (DLQI)

  Week 6 and Week 26

• Changes from Baseline in total ulcer area

  Week 6 and Week 26

Study Arms (1)

Arm A

EXPERIMENTAL

Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).

Drug: adalimumab

Interventions

adalimumab DRUG

Study drug will be administered subcutaneously.

Also known as: Humira®

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (20)

Nagoya City University Hospital /ID# 164510

Nagoya, Aichi-ken, 467-8602, Japan

Location

Juntendo University Urayasu Hospital /ID# 164422

Urayasu Shi, Chiba, 279-0021, Japan

Location

Fukuoka University Hospital /ID# 164416

Fukuoka, Fukuoka, 814-0180, Japan

Location

Fukushima Medical University Hospital /ID# 164358

Fukushima, Fukushima, 960-1295, Japan

Location

Gunma University Hospital /ID# 164464

Maebashi, Gunma, 371-8511, Japan

Location

Asahikawa Medical University Hospital /ID# 164589

Asahikawa-shi, Hokkaido, 078-8510, Japan

Location

Showa University Fujigaoka Hospital /ID# 164406

Yokohama, Kanagawa, 227-0043, Japan

Location

Mie University Hospital /ID# 164389

Tsu, Mie-ken, 514-8507, Japan

Location

Tohoku University Hospital /ID# 164360

Sendai, Miyagi, 980-8574, Japan

Location

Shinshu University Hospital /ID# 164852

Matsumoto-shi, Nagano, 〒390-8621, Japan

Location

Nagasaki University Hospital /ID# 167604

Nagasaki, Nagasaki, 852-8501, Japan

Location

University of the Ryukyus Hospital /ID# 164981

Nakagami-gun, Okinawa, 903-0215, Japan

Location

Hamamatsu University Hospital /ID# 165890

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Tokushima University Hospital /ID# 164359

Tokushima, Tokushima, 770-8503, Japan

Location

Teikyo University Hospital /ID# 165665

Itabashi-ku, Tokyo, 173-8605, Japan

Location

Tokyo Medical University Hospital /ID# 165810

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Keio University Hospital /ID# 165680

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Yamaguchi University Hospital /ID# 164562

Ube-shi, Yamaguchi, 7558505, Japan

Location

Kansai Medical Univ Hosp /ID# 165802

Hirakata-shi, Osaka, 573-1191, Japan

Location

Hokkaido University Hospital /ID# 164419

Sapporo, 060-8648, Japan

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Pyoderma Gangrenosum; Ulcer

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: October 27, 2017
• Primary Completion: August 20, 2019
• Study Completion: April 21, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

JP (20)