EUCTR2020-003273-21-PL进行中（未招募）1 期
Open label exploratory phase IIa trial to investigate the safety and efficacy of IFX-1 in treating subjects with Pyoderma Gangrenosum (OPTIMA). - Exploratory study of IFX-1 in Subjects with Pyoderma Gangrenosum
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- InflaRx GmbH
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Capable of giving signed informed consent as described in Regulatory and Ethical Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol, and approval for photographic documentation
- •2. Subjects must be 18 years or older, at the time of signing the informed consent
- •3. Male or female
- •4.Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator
- •5.In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:History of
- •Pathergy (ulcer occurring at the sites of trauma)
- •Personal history of inflammatory bowel disease or inflammatory arthritis
- •History of papule, pustule or vesicle that rapidly ulcerated
- •Clinical examination (or photographic evidence) of
- •Peripheral erythema, undermining border, and tenderness at site of ulceration
- •Multiple ulcerations
- •Cribriform or wrinkled paper” scar(s) at sites of healed ulcers
- •6.Subject has a minimum of 1 evaluable ulcer (=2 cm2) at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •1.Pyoderma gangrenosum target ulcer for more than 3 years before screening
- •2.Surgical wound debridement within the previous 2 weeks before screening
- •3.Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator
- •4.Poor general condition that might affect wound healing, as determined by the investigator
- •5.One of the following abnormal laboratory findings at screening:
- •White blood cell count <3500/mm3
- •Platelet count <100,000/mm3
- •Hemoglobin <7 g/dL
- •Total bilirubin >1.5 times the upper limit of normal and/or alanine aminotransferase or aspartate aminotransferase >2.5 times upper limit of normal
- •6.Human immunodeficiency virus, hepatitis B or hepatitis C viral screening test showing evidence of active or chronic viral infection at screening or a documented history of the human immunodeficiency virus, hepatitis B, or hepatitis C
- •7.Evidence of active or latent tuberculosis
- •8.History of malignancy in the previous 5 years (except for non-melanoma skin cancer and cancer in-situ of the cervix)
- •9.Subjects with ulceration due to medical causes other than pyoderma gangrenosum (e.g. diabetic ulceration)
- •10.Infection requiring suppressive anti-infective therapy (such as latent tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
- •11.Use of intravenous antibacterial, antiviral, anti-fungal, or anti-parasitic agents within 30 days before screening
- •12.Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg prednisone or prednisone equivalent), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
- •13.Received live attenuated vaccine within the previous 3 months before screening
- •14.Major surgery planned during the time of foreseen study participation
- •15.The subject has participated in an interventional clinical study during the 3 months before screening, or plans to participate in a clinical study
- •16.Previous exposure to IFX-1 in this or another study
- •17.Known hypersensitivity to polysorbate 80 (excipient of the IMP)
- •18.Prior exposure to anticomplement 5a before screening
- •19.History of sever anaphylactic reaction to any components of C5a before screening
- •20.Known or suspected active drug and/or alcohol abuse at screening
- •21.Breast feeding or pregnant woman at screening
- •22.Male and female subjects of childbearing potential unwilling to follow the contraceptive guidance in Appendix 4 during the treatment period and for at least 30 days after the last dose of IMP
- •23.Pregnancy or positive pregnancy test at screening
- •24.The subject is imprisoned or lawfully kept in an institution at screening
- •25.Evidence or suspicion that the subject might not comply with the requirements of the study protocol
- •26.The subject is an employee or direct relative of an employee at the study site or sponsor
- •27.Any other factor which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the study
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