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Exploratory Study of IFX-1 in Subjects With Pyoderma Gangrenosum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971643
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Innovaderm Research Inc.
Information provided by (Responsible Party):
InflaRx GmbH

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

Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Drug: IFX-1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: IV infusions of IFX-1 diluted in sodium chloride
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Exploratory Phase 2a Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Subjects With Pyoderma Gangrenosum (Optima)
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IFX-1
Exploratory, Proof of Concept with a total of 15 doses of IFX-1.
Drug: IFX-1
IV infusions of IFX-1 diluted in sodium chloride.
Other Name: CaCP29




Primary Outcome Measures :
  1. Explore the safety of IFX-1 for the treatment of subjects with pyoderma gangrenosum: Occurrence, nature and intensity of treatment emergent adverse events (TEAEs), related TEAEs, and serious TEAEs. [ Time Frame: through study completion, up to 36 weeks ]
    The endpoints will be the occurrence, nature and intensity of treatment emergent adverse events (TEAEs), related TEAEs, serious TEAEs and adverse events of special interest.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971643


Contacts
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Contact: Korinna Pilz, MD, MSc +49 89 4141 8978 97 info@inflarx.de

Locations
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United States, California
InflaRx Site #07 Recruiting
Sacramento, California, United States, 95816
United States, Florida
InflaRx Site #08 Not yet recruiting
Miami, Florida, United States, 33125
InflaRx Site #03 Recruiting
Tampa, Florida, United States, 33613
United States, Missouri
InflaRx Site #10 Recruiting
Saint Louis, Missouri, United States, 63110
United States, Ohio
InflaRx Site #05 Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
InflaRx Site #06 Withdrawn
Philadelphia, Pennsylvania, United States, 19104-6205
InflaRx Site #09 Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
InflaRx Site #04 Withdrawn
San Antonio, Texas, United States, 78213
Canada, Ontario
InflaRx Site #01 Completed
Richmond Hill, Ontario, Canada
Canada, Quebec
InflaRx Site #02 Withdrawn
Montréal, Quebec, Canada
Sponsors and Collaborators
InflaRx GmbH
Innovaderm Research Inc.
Investigators
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Study Director: Korinna Pilz, MD, MSc InflaRx GmbH
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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT03971643    
Other Study ID Numbers: IFX-1-P2.7
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer