Pyoderma GangrenosumNCT04750213
A Study to Assess Adverse Events and Change in Disease State in Adult Participants Being Treated With Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
An observational study of Pyoderma Gangrenosum, run by AbbVie at 46 sites in Japan.
Trial summary
Pyoderma Gangrenosum (PG) is a rapidly progressive disease and presents as painful, single or multiple lesions, with several clinical variants, in different locations, with a nonspecific histology, which makes the diagnosis challenging and often delayed. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- How many people
- 60 participants
- Where
- 46 sitesJapan
- Study dates
- 12 Feb 2021to 11 Nov 2024
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients
Who may be able to join
- Diagnosed with Pyoderma Gangrenosum (PG).
- Have been prescribed Humira for PG treatment within 14 days.
Who cannot join
- Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Japan46 sites
Akita University Hospital /ID# 242706
Akita, Akita, 010-8543
Kansai Rosai Hospital /ID# 246592
Amagasaki-shi, Hyōgo, 660-8511
The University of Tokyo Hospital /ID# 250194
Bunkyo-ku, Tokyo, 113-8655
Fukuchiyama City Hospital /ID# 246593
Fukuchiyama-shi, Kyoto, 620-8505
Kyushu University Hospital /ID# 247492
Fukuoka, Fukuoka, 812-8582
Japanese Red Cross Fukuoka Hospital /ID# 244051
Fukuoka, Fukuoka, 815-8555
Hamamatsu University Hospital /ID# 240817
Hamamatsu, Shizuoka, 431-3192
Kansai Medical University Hospital /ID# 228783
Hirakata-shi, Osaka, 573-1191
Chutoen General Medical Center /Id# 228780
Kakegawa-shi, Shizuoka, 436-0040
Ishikawa Prefectural Central Hospital /ID# 239089
Kanazawa, Ishikawa-ken, 920-8530
Kanazawa University Hospital /ID# 248730
Kanazawa, Ishikawa-ken, 920-8641
Nara Medical University Hospital /ID# 241880
Kashihara-shi, Nara, 634-8522
Teikyo University Mizonokuchi Hospital /ID# 244693
Kawasaki, Kanagawa, 213-8507
Kobe University Hospital /ID# 249396
Kobe, Hyōgo, 650-0017
Nishi-Kobe Medical Center /ID# 244224
Kobe, Hyōgo, 651-2273
Dokkyo Medical University Saitama Medical Center /ID# 248731
Koshigaya, Saitama, 343-0845
Kumamoto University Hospital /ID# 244050
Kumamoto, Kumamoto, 8608556
Kurume University Hospital /ID# 246502
Kurume-shi, Fukuoka, 830-0011
Gunma University Hospital /ID# 239390
Maebashi, Gunma, 371-8511
Shinshu University Hospital /ID# 230272
Matsumoto-shi, Nagano, 390-8621
The Jikei University Hospital /ID# 252112
Minato-ku, Tokyo, 105-8471
Central Japan International Medical Center /ID# 239391
Minokamo-shi, Gifu, 505-8510
University of Miyazaki Hospital /ID# 241179
Miyazaki, Miyazaki, 889-1692
NHO Nagoya Medical Center /ID# 246013
Nagoya, Aichi-ken, 460-0001
Nagoya City University Hospital /ID# 233778
Nagoya, Aichi-ken, 467-8602
Okinawa Kyodo Hospital /ID# 241739
Naha, Okinawa, 900-0024
Naha City Hospital /ID# 240818
Naha, Okinawa, 902-0061
University of the Ryukyus Hospital /ID# 252114
Nakagami-gun, Okinawa, 903-0215
Okayama University Hospital /ID# 238746
Okayama, Okayama-ken, 700-8558
Japanese Red Cross Osaka Hospital /ID# 228782
Osaka, Osaka, 543-8555
Takatsuki General Hospital /ID# 244694
Osaka
Kindai University Hospital /ID# 252568
Osakasayama-shi, Osaka, 589-8511
Sapporo Medical University Hospital /ID# 241180
Sapporo, Hokkaido, 060-8543
Hokkaido University Hospital /ID# 252567
Sapporo, Hokkaido, 060-8648
Hokkaido Medical Center /ID# 251657
Sapporo, Hokkaido, 063-0005
Tohoku University Hospital /ID# 252113
Sendai, Miyagi, 9808574
Tohoku Medical and Pharmaceuti /ID# 230270
Sendai, Miyagi, 983-0005
Tokyo Medical University Hospital /ID# 233780
Shinjuku-ku, Tokyo, 160-0023
Shizuoka Saiseikai Genaral Hospital /ID# 239088
Shizuoka, Shizuoka, 422-8527
Takamatsu Red Cross Hospital /ID# 240576
Takamatsu, Kagawa-ken, 760-0017
Kagawa Prefectural Central Hospital /ID# 250193
Takamatsu, Kagawa-ken, 760-0065
Teikyo University Hospital /ID# 239389
Tokyo, 173-8605
Mie University Hospital /ID# 238747
Tsu, Mie-ken, 514-8507
Yamanashi Kosei Hospital /ID# 242168
Yamanashi, Yamanashi, 405-0033
Yokohama Municipal Citizen's Hospital /ID# 233779
Yokohama, Kanagawa, 221-0855
Yokohama Minami Kyousai Hosp /ID# 252892
Yokohama, Kanagawa, 236-0037
About this study
Official title: Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
Pyoderma Gangrenosum (PG) is a rapidly progressive disease and presents as painful, single or multiple lesions, with several clinical variants, in different locations, with a nonspecific histology, which makes the diagnosis challenging and often delayed. The main objective of this study is to estimate the incidence proportion of all the infection reported as adverse drug reaction (ADR) of Humira with PG participants.
Humira is the only drug approved for the treatment of Pyoderma Gangrenosum (PG) in Japan. Approximately 60 adult participants with PG at approximately 60 sites in Japan.
Read more
Participants will receive injectable Humira (Adalimumab) as prescribed by the physician prior to enrolling in this study.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by verbal interview.
- Conditions
- Pyoderma Gangrenosum
- Keywords
- Pyoderma Gangrenosum, Humira, Adalimumab
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Humira (Adalimumab) | Participants receiving Adalimumab for Pyoderma Gangrenosum (PG). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Secondary outcomes (10)
Incidence Percentage of Serious Infection Reported as ADR
An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Incidence Percentage of each ADR (Besides Infection)
An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Change in Physician's Global Assessment (PGA) [Global] Grade
PGA will be used for overall assessment of efficacy.
Measured: Up to Week 52
Change in PGA [Target] Grade
PGA will be used for assessment of efficacy of target lesions.
Measured: Up to Week 52
Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing
IIA will be used for assessment of efficacy of target lesions.
Measured: Up to Week 52
Change in Verbal Rating Scale (VRS) Category
Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain.
Measured: Up to Week 52
Percentage of Participants with Recurrence
Recurrence of PG.
Measured: Up to Week 52
Time to Recurrence (Day)
Recurrence of PG.
Measured: Up to Week 52
Percentage of PG Subtype at Recurrence
Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative).
Measured: Up to Week 52
Pain Improvement Assessed with VRS
Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain.
Measured: Week 26 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start12 Feb 2021
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT04750213
- Sponsor's protocol ID
- P20-251
- Status last verified
- Jul 2025
- First submitted
- 10 Feb 2021
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yamamoto T, Tanizaki H, Yamasaki K, Matsubara N, Nakayama M, Iwashita E, Yamanaka K. Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study. Dermatol Ther (Heidelb). 2026 Jun;16(6):3167-3188. doi: 10.1007/s13555-026-01772-4. Epub 2026 May 10.
PubMed 42107018
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
- ClinicalTrials.gov ID
- NCT04750213
- Acronym / sponsor ID
- P20-251
- Conditions
- Pyoderma Gangrenosum
- Keywords
- Pyoderma Gangrenosum, Humira, Adalimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 11 Feb 2021 (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.
Pyoderma Gangrenosum (PG) is a rapidly progressive disease and presents as painful, single or multiple lesions, with several clinical variants, in different locations, with a nonspecific histology, which makes the diagnosis challenging and often delayed. The main objective of this study is to estimate the incidence proportion of all the infection reported as adverse drug reaction (ADR) of Humira with PG participants.
Humira is the only drug approved for the treatment of Pyoderma Gangrenosum (PG) in Japan. Approximately 60 adult participants with PG at approximately 60 sites in Japan.
Participants will receive injectable Humira (Adalimumab) as prescribed by the physician prior to enrolling in this study.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by verbal interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Humira (Adalimumab) | – | –Participants receiving Adalimumab for Pyoderma Gangrenosum (PG). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients
Key inclusion criteria (2 listed)
- Diagnosed with Pyoderma Gangrenosum (PG).
- Have been prescribed Humira for PG treatment within 14 days.
Key exclusion criteria (1 listed)
- Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR)
Time frame: Up to 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
10 secondary outcomes
Incidence Percentage of Serious Infection Reported as ADR
Time frame: Up to 52 weeks
Incidence Percentage of each ADR (Besides Infection)
Time frame: Up to 52 weeks
Change in Physician's Global Assessment (PGA) [Global] Grade
Time frame: Up to Week 52
Change in PGA [Target] Grade
Time frame: Up to Week 52
Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing
Time frame: Up to Week 52
Change in Verbal Rating Scale (VRS) Category
Time frame: Up to Week 52
Percentage of Participants with Recurrence
Time frame: Up to Week 52
Time to Recurrence (Day)
Time frame: Up to Week 52
Percentage of PG Subtype at Recurrence
Time frame: Up to Week 52
Pain Improvement Assessed with VRS
Time frame: Week 26 to Week 52
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 17 Jul 2025.
- Derived from this study: PubMed 42107018Yamamoto T, Tanizaki H, Yamasaki K, Matsubara N, Nakayama M, Iwashita E, Yamanaka K. Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study. Dermatol Ther (Heidelb). 2026 Jun;16(6):3167-3188. doi: 10.1007/s13555-026-01772-4. Epub 2026 May 10.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pyoderma Gangrenosum, run by AbbVie at 46 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 2 inclusion and 1 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 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.
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?
Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR) (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750213, which also lists 1 linked publication.
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 17 Jul 2025.