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NCT04750213
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)
trial in Pyoderma Gangrenosum in 60 participants. Completed in 11 November 2024.
11 November 2024
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 12 February 2021 |
| Primary completion | 11 November 2024 |
| Estimated completion | 11 November 2024 |
| Sites | 46 locations across Japan |
Conditions studied
- Pyoderma Gangrenosum — all drugs for Pyoderma Gangrenosum →
Sponsor
AbbVie — full company profile →
Who can join
15 and older, any sex, with Pyoderma Gangrenosum. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Pathophysiology and Treatment of Pyoderma Gangrenosum-Current Options and New Perspectives.
Łyko M, Ryguła A, Kowalski M, Karska J, et al · · 2024 · cited 19× · PMID 38397117 · DOI 10.3390/ijms25042440 -
Real-world safety and effectiveness of adalimumab in patients with pyoderma gangrenosum: Interim analysis of a post-marketing observational study in Japan.
Yamamoto T, Yamanaka K, Yamasaki K, Isaji H, et al · · 2025 · cited 5× · PMID 39535411 · DOI 10.1111/1346-8138.17547 -
Pyoderma Gangrenosum in a Patient with Crohn's Disease Treated with Adalimumab: A Case-Based Review and Systematic Review of the Current Literature.
Fousekis FS, Mpakogiannis K, Karampinis E, Mastorogianni IN, et al · · 2025 · cited 1× · PMID 40136593 · DOI 10.3390/clinpract15030057 -
Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study.
Yamamoto T, Tanizaki H, Yamasaki K, Matsubara N, et al · · 2026 · PMID 42107018 · DOI 10.1007/s13555-026-01772-4
Verify or expand the search:
- PubMed search for NCT04750213
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pyoderma Gangrenosum
Currently open trials in the same condition.
- NCT06624670 — A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum · Phase 3 · recruiting
- NCT06563323 — Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG) · Phase 2 · recruiting
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04750213 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 17 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04750213.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing