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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 : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

Study Description
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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

Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Drug: vilobelimab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 15, 2023
Estimated Primary Completion Date : February 13, 2026
Estimated Study Completion Date : May 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: vilobelimab
Patients will be treated with vilobelimab IV, Q2W for 26 weeks
 Drug: vilobelimab
vilobelimab infusion
Placebo Comparator: Placebo
Patients will receive placebo IV in the same schedule as patients in Arm 1
 Drug: Placebo
Placebo Infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


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

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).
Contacts and Locations
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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): NCT05964413


Contacts
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Contact: Dorothee Neukirchen, Dr. +49 89 4141897800 clinicaltrials@inflarx.de
Contact: Alex GO Loayza, Prof, MD +49 89 414 189 78 00

Locations
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Sponsors and Collaborators
InflaRx GmbH
More Information
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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT05964413    
Other Study ID Numbers: IFX-1-P3.4
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: March 2024

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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
 Vilobelimab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs