BridgeMD
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate the efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum.
EU CTIS ID: 2023-506250-20-00
What this study is testing
To evaluate the efficacy of treatment with vilobelimab compared to placebo in patients with PG
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent.
- 18 years or older at the time of signing the informed consent.
- Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be supported by clinical assessment of PG symptoms via PARACELSUS score of 10 points or more
- Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria • area of ≥ 5 cm2 at screening and baseline • circulated by intact skin • evaluable by at least 2-dimensional measurement
You likely can't join if
- Patients with target ulcers exceeding 80 cm2.
- Patient has a history of malignancies during the past 5 years other than successfully treated basal cell carcinoma, locally non-advanced, non-metastatic cutaneous squamous cell carcinoma, or carcinoma of the cervix in situ.
- Patients with known congestive heart failure (New York Heart Association criteria Class III or IV).
- Patients with known progressed liver disease (Child-Pugh class B or C).
- Patients received any systemic medical treatment for PG within 4 weeks prior to baseline (i.e., start of treatment with IMP) (e.g., cyclosporine, mycophenolate mofetil, methotrexate [MTX], azathioprine [AZA], intravenous immunoglobulin [IVIg], systemic corticosteroids other than as detailed under exclusion criterion 14) and 15), or receives/received topical or intralesional treatment within 2 weeks prior to baseline (i.e., start of treatment with IMP).
- 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; e.g.: psoriasis, inflammatory bowel disease (IBD)) at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening, this is allowed to be continued.
See the full eligibility criteria
Who can join
- Signed informed consent.
- 18 years or older at the time of signing the informed consent.
- Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be supported by clinical assessment of PG symptoms via PARACELSUS score of 10 points or more
- Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria • area of ≥ 5 cm2 at screening and baseline • circulated by intact skin • evaluable by at least 2-dimensional measurement
What rules you out
- Patients with target ulcers exceeding 80 cm2.
- Patient has a history of malignancies during the past 5 years other than successfully treated basal cell carcinoma, locally non-advanced, non-metastatic cutaneous squamous cell carcinoma, or carcinoma of the cervix in situ.
- Patients with known congestive heart failure (New York Heart Association criteria Class III or IV).
- Patients with known progressed liver disease (Child-Pugh class B or C).
- Patients received any systemic medical treatment for PG within 4 weeks prior to baseline (i.e., start of treatment with IMP) (e.g., cyclosporine, mycophenolate mofetil, methotrexate [MTX], azathioprine [AZA], intravenous immunoglobulin [IVIg], systemic corticosteroids other than as detailed under exclusion criterion 14) and 15), or receives/received topical or intralesional treatment within 2 weeks prior to baseline (i.e., start of treatment with IMP).
- 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; e.g.: psoriasis, inflammatory bowel disease (IBD)) at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening, this is allowed to be continued.
- 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). Note: If a patient is on oral corticosteroid therapy, the dose must be tapered to 10 mg/day prednisone (or its equivalent) and the dose must be stable for at least 4 weeks prior to baseline, without visual decrease in the target ulcer size between screening and baseline according to investigators’ judgment. Patients with no prior corticosteroid therapy are allowed to receive up to 10 mg/day prednisone (or its equivalent) prior to baseline (i.e., start of treatment with IMP).
- Major surgery planned during the time of the foreseen study participation.
- The patient has participated in an interventional clinical trial and is known to have received active treatment during the 3 months before screening or plans to participate in another clinical trial.
- Known or suspected drug and/or alcohol abuse.
- Women of childbearing potential (WOCBP) who have a positive serum pregnancy test result within 7 days before treatment or are breast feeding. Note: Postmenopausal women must be amenorrheic for ≥ 12 months to be considered not WOCBP.
- Patients with target ulcer in transplanted skin
- WOCBP and males of any age unwilling to practice an effective method of contraception during the treatment period and for at least 30 days after the last dose of IMP.
- Any existing concomitant disease which, in the investigator’s opinion, is likely to compromise the patient’s ability to participate in the study or would interfere with the efficacy assessment of the trial.
- Significant improvement and visual ulcer decrease of the target ulcer between screening and baseline (i.e., start of treatment with IMP) as judged by the investigator supported by standardized photography.
- 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).
- Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP).
- Patient with known severe or life-threatening hypersensitivity reaction to any other therapeutic antibodies according to Common Terminology Criteria for Adverse Events (CTCAE) such as breathing difficulty, dizziness, hypotension, cyanosis, and loss of consciousness.
- Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP).
- Any active infection requiring systemic antibiotic or other systemic treatment or suppressive anti-infective therapy (e.g., erysipelas, herpes zoster, syphilis, pneumonia, tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, and atypical mycobacteria) within 2 weeks prior to baseline (i.e., start of treatment with IMP).
- Patient has a known history of tuberculosis, human immunodeficiency virus (HIV) infection or a known history of or a suspected current hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Switzerland
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Switzerland; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.