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出境医 / 临床实验 / Exploratory Study of IFX-1 in Subjects With Pyoderma Gangrenosum

Exploratory Study of IFX-1 in Subjects With Pyoderma Gangrenosum

Study Description
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.
Study Design
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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 : April 2022
Estimated Study Completion Date : April 2022
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
Poland
InflaRx Site #21 Recruiting
Rzeszów, Poland, 35-055
InflaRx Site #20 Recruiting
Wrocław, Poland, 50-566
Sponsors and Collaborators
InflaRx GmbH
Innovaderm Research Inc.
Investigators
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Study Director: Korinna Pilz, MD, MSc InflaRx GmbH
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE May 16, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		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, and serious TEAEs.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study of IFX-1 in Subjects With Pyoderma Gangrenosum
Official Title  ICMJE Open Label Exploratory Phase 2a Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Subjects With Pyoderma Gangrenosum (Optima)
Brief Summary The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of pyoderma gangrenosum.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Pyoderma Gangrenosum
Intervention  ICMJE Drug: IFX-1
IV infusions of IFX-1 diluted in sodium chloride.
Other Name: CaCP29
Study Arms  ICMJE Experimental: IFX-1
Exploratory, Proof of Concept with a total of 15 doses of IFX-1.
Intervention: Drug: IFX-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2020) 		18
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		12
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Korinna Pilz, MD, MSc +49 89 4141 8978 97 info@inflarx.de
Listed Location Countries  ICMJE Canada,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971643
Other Study ID Numbers  ICMJE IFX-1-P2.7
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InflaRx GmbH
Study Sponsor  ICMJE InflaRx GmbH
Collaborators  ICMJE Innovaderm Research Inc.
Investigators  ICMJE
Study Director: Korinna Pilz, MD, MSc InflaRx GmbH
PRS Account InflaRx GmbH
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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