CTIS2023-506250-20-00招募中1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, ADAPTIVE PHASE III TRIAL TOINVESTIGATE EFFICACY AND SAFETY OF VILOBELIMAB IN THE TREATMENT OF ULCERATIVE PYODERMAGANGRENOSUM - IFX-1-P3.4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- InflaRx GmbH
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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 hypersensitivi
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