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

Purpose

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

  • Pyoderma Gangrenosum

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

The University of Texas Health Science Center at Houston
Bellaire, Texas 77401

More Details

Status
Recruiting
Sponsor
InflaRx GmbH

Study Contact

Dorothee Neukirchen, Dr.
+49 89 4141897800
clinicaltrials@inflarx.de; clinicaltrials@inflarx.com