Exploratory Study of IFX-1 in Subjects With Pyoderma Gangrenosum

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    18
  • sponsor
    InflaRx GmbH
Updated on 25 April 2021

Summary

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of pyoderma gangrenosum.

Description

Neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. Pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. This study is set up based on the hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

Details
Condition Pyoderma Gangrenosum
Treatment IFX-1
Clinical Study IdentifierNCT03971643
SponsorInflaRx GmbH
Last Modified on25 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator
In addition, the subject must fulfill at least 3 of the following 6 criteria
at screening
History of
Pathergy (ulcer occurring at the sites of trauma)
Personal history of inflammatory bowel disease or inflammatory arthritis
History of papule, pustule or vesicle that rapidly ulcerated
Clinical examination (or photographic evidence) of
Peripheral erythema, undermining border, and tenderness at site of ulceration
Multiple ulcerations (at least 1 occurring on the lower leg)
Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers
Subject has a minimum of 1 evaluable ulcer (2 cm2) on the lower extremity at
screening

Exclusion Criteria

Pyoderma gangrenosum target ulcer for more than 3 years before screening
Surgical wound debridement within the previous 2 weeks before screening
Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening
Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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