Pyoderma GangrenosumPhase 3NCT03311464
A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
A Phase 3 study testing adalimumab in people with Pyoderma Gangrenosum, run by AbbVie at 20 sites in Japan.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 20 sitesJapan
- Study dates
- 27 Oct 2017to 21 Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Asahikawa Medical University Hospital /ID# 164589
Asahikawa-shi, Hokkaido, 078-8510
Fukuoka University Hospital /ID# 164416
Fukuoka, Fukuoka, 814-0180
Fukushima Medical University Hospital /ID# 164358
Fukushima, Fukushima, 960-1295
Hamamatsu University Hospital /ID# 165890
Hamamatsu, Shizuoka, 431-3192
Kansai Medical Univ Hosp /ID# 165802
Hirakata-shi, Osaka, 573-1191
Gunma University Hospital /ID# 164464
Maebashi, Gunma, 371-8511
Shinshu University Hospital /ID# 164852
Matsumoto-shi, Nagano, 〒390-8621
Nagasaki University Hospital /ID# 167604
Nagasaki, Nagasaki, 852-8501
Nagoya City University Hospital /ID# 164510
Nagoya, Aichi-ken, 467-8602
University of the Ryukyus Hospital /ID# 164981
Nakagami-gun, Okinawa, 903-0215
Hokkaido University Hospital /ID# 164419
Sapporo, 060-8648
Tohoku University Hospital /ID# 164360
Sendai, Miyagi, 980-8574
Tokyo Medical University Hospital /ID# 165810
Shinjuku-ku, Tokyo, 160-0023
Keio University Hospital /ID# 165680
Shinjuku-ku, Tokyo, 160-8582
Teikyo University Hospital /ID# 165665
tabashi City, Tokyo, 173-8605
Tokushima University Hospital /ID# 164359
Tokushima, Tokushima, 770-8503
Mie University Hospital /ID# 164389
Tsu, Mie-ken, 514-8507
Yamaguchi University Hospital /ID# 164562
Ube-shi, Yamaguchi, 7558505
Juntendo University Urayasu Hospital /ID# 164422
Urayasu Shi, Chiba, 279-0021
Showa University Fujigaoka Hospital /ID# 164406
Yokohama, Kanagawa, 227-0043
About this study
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
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
- Being tested
- adalimumab
- Keywords
- Pyoderma Gangrenosum, Ulcer, Efficacy, Safety, Adalimumab, Humira®, Japan
- Medical subject headings
- Pyoderma Gangrenosum, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabDrug
Also called Humira®
Study drug will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s). Receives: Drug: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 26
Secondary outcomes (19)
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.
Measured: Week 6 and Week 26
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.
Measured: Up to Week 26
Change from Baseline in total number of active ulcers
The number of all active PG ulcers will be counted at the specified visits.
Measured: Week 26
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.
Measured: Week 6 and Week 26
Changes from Baseline in total ulcer area
The change in total ulcer area is assessed.
Measured: Week 6 and Week 26
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.
Measured: Up to Week 26
Mean time to occurrence of a new PG ulcer(s)
Mean time to occurrence of a new PG ulcer(s) is assessed.
Measured: Up to Week 52
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.
Measured: Up to Week 52
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.
Measured: Week 52
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.
Measured: Up to Week 26
Percentage change in target Pyoderma Gangrenosum (PG) ulcer area
The percentage change in target PG ulcer area is assessed.
Measured: Up to Week 26
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.
Measured: Week 6 and Week 26
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.
Measured: Week 6 and Week 26
Changes from baseline in the proportion of participants taking analgesics
Proportion of participants taking analgesics is assessed.
Measured: Week 6 and Week 26
Velocities of healing
This is assessed from baseline.
Measured: Up to Week 26
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.
Measured: Week 6
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.
Measured: Week 52
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.
Measured: Up to Week 26
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.
Measured: Up to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start27 Oct 2017
- Primary completion20 Aug 2019
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311464
- Sponsor's protocol ID
- M16-119
- Status last verified
- Mar 2021
- First submitted
- 12 Oct 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03311464
- Acronym / sponsor ID
- M16-119
- Conditions
- Pyoderma Gangrenosum
- Keywords
- Pyoderma Gangrenosum, Ulcer, Efficacy, Safety, Adalimumab, Humira®, Japan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: adalimumabParticipants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: Humira®Study drug will be administered subcutaneously. | Drug | Arm A |
Primary outcome
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.
19 secondary outcomes
Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1
Time frame: Week 6 and Week 26
Mean time to occurrence of new PG ulcers
Time frame: Up to Week 26
Change from Baseline in total number of active ulcers
Time frame: Week 26
Change from Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Week 6 and Week 26
Changes from Baseline in total ulcer area
Time frame: Week 6 and Week 26
Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score
Time frame: Up to Week 26
Mean time to occurrence of a new PG ulcer(s)
Time frame: Up to Week 52
Mean time to healing of target ulcer
Time frame: Up to Week 52
Proportion of participants achieving healing per PGAR for the target ulcer
Time frame: Week 52
Proportion of participants who have achieved target 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 PGA 0
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
Changes from baseline in the proportion of participants taking analgesics
Time frame: Week 6 and Week 26
Velocities of healing
Time frame: Up to Week 26
Proportion of participants achieving ulcer healing as assessed by PGAR
Time frame: Week 6
Proportion of participants achieving PGA 0 of all PG ulcers
Time frame: Week 52
Mean time to relapse of the target PG ulcer
Time frame: Up to Week 26
Mean time to healing as defined by PGAR
Time frame: Up to Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab in people with Pyoderma Gangrenosum, run by AbbVie at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.