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Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum

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ClinicalTrials.gov Identifier: NCT05964413
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

Tracking Information
First Submitted Date  ICMJE June 29, 2023
First Posted Date  ICMJE July 27, 2023
Last Update Posted Date April 30, 2024
Actual Study Start Date  ICMJE August 15, 2023
Estimated Primary Completion Date February 13, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2023)		 Efficacy of treatment with vilobelimab compared to placebo [ Time Frame: Week 1 to Week 26 ]
Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2023)		 To evaluate the efficacy of treatment with vilobelimab compared to placebo in patients with PG [ Time Frame: Week 1 to Week 26 ]
Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2023)
  • Efficacy of treatment with vilobelimab compared to placebo [ Time Frame: 2 weeks between study visits ]
    Proportion of patients achieving disease remission up to and including EOT visit; where disease remission is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) of all PG ulcers, without drainage or dressing requirements
  • Pain reduction [ Time Frame: Week 10 through study completion ]
    Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline
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 Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum
Brief Summary A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pyoderma Gangrenosum
Intervention  ICMJE
  • Drug: vilobelimab
    vilobelimab infusion
  • Drug: Placebo
    Placebo Infusion
Study Arms  ICMJE
  • Experimental: vilobelimab
    Patients will be treated with vilobelimab IV, Q2W for 26 weeks
    Intervention: Drug: vilobelimab
  • Placebo Comparator: Placebo
    Patients will receive placebo IV in the same schedule as patients in Arm 1
    Intervention: Drug: Placebo
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: July 24, 2023)		 90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2026
Estimated Primary Completion Date February 13, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  1. 18 years or older at the time of signing the informed consent.
  2. Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be supported by clinical assessment of PG symptoms via PARACELSUS score (Jockenhofer, Wollina et al. 2019) of 10 points or more (see Appendix - Section 12.1). Note: in case of PARACELSUS score < 10, additional justification shall be provided by the investigator to support clinical diagnosis of ulcerative PG.

  3. Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria (Orfaly, Reese et al. 2022): area of ≥ 5 cm 2 at screening and baseline

    • circulated by intact skin
    • evaluable by at least 2-dimensional measurement

Main Exclusion Criteria:

  1. Patients with target ulcers exceeding 80 cm 2 .
  2. Patients with target ulcer in transplanted skin.
  3. Surgical wound debridement or negative pressure wound therapy (NPWT) for the target ulcer within 4 weeks before baseline (i.e., start of treatment with IMP).
  4. Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP).
  5. Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP).
  6. Any active infection requiring systemic antibiotic or other systemic treatment or suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of treatment with IMP).
  7. Patients received any systemic medical treatment for PG within 4 weeks prior to baseline
  8. Patients received any biological or immunomodulatory therapy for PG within 4 weeks prior to baseline (i.e., start of treatment with IMP), except existing biologic or immunomodulatory therapy used for an underlying disease (other than PG at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening this is allowed to be continued.
  9. Patients receiving corticosteroids treatment for PG of more than 10 mg/day of prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment with IMP).
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: Dorothee Neukirchen, Dr. +49 89 4141897800 clinicaltrials@inflarx.de
Contact: Alex GO Loayza, Prof, MD +49 89 414 189 78 00
Listed Location Countries  ICMJE Australia,   France,   Germany,   Hungary,   Italy,   Poland,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05964413
Other Study ID Numbers  ICMJE IFX-1-P3.4
Has Data Monitoring Committee Not Provided
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 Not Provided
Current Responsible Party InflaRx GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE InflaRx GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InflaRx GmbH
Verification Date April 2024

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