NL-OMON46646已完成2 期
A randomized, double-blind, placebo-controlled, multicenter Phase II study to determine efficacy and safety of IFX-1 in subjects with moderate to severe hidradenitis suppurativa - SHINE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- InflaRx GmbH
- 入组人数
- 4
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 99（—）
入选标准
- •1. Male or female, * 18 years of age
- •2. Written informed consent obtained from subject
- •3. Diagnosis of Hidradentis Suppurativa (HS) for at least 1 year
- •4. Moderate or severe HS, as indicated by HS lesions in at least 2 distinct
- •areas, 1 of which must be at least Hurley Stage II or Stage III
- •5. Stable HS for at least 2 months before Screening, as determined by
- •the investigator through subject interview and review of medical history
- •6. Inadequate response to at least 3 months of oral antibiotics, or
- •intolerance to antibiotics
- •7. Total abscess and inflammatory nodule count of * 3
排除标准
- •1. Body weight < 60 or > 130 kg
- •2. Any other skin disease that may interfere with assessment of HS
- •3. More than 20 draining fistulas
- •4. Prior treatment with adalimumab or another biologic product during
- •the 24 weeks before Screening
- •5. Prior treatment with IFX-1
- •6. Subjects on permitted oral antibiotic treatment for HS (doxycycline or
- •minocycline only) who have not been on a stable dose during the 28
- •days before Screening
- •7. Subject received systemic non-biologic therapy for HS with potential
- •therapeutic impact for HS during the 28 days before Screening (other
- •than permitted oral antibiotics)
- •8. Prior treatment with any of the following medications during the 28
- •days before Screening:
- •a. Any other systemic therapy for HS
- •b. Any iv anti-infective therapy
- •c. Phototherapy (UVB or psoralen and UVA)
- •9. Prior treatment with any of the following medications during the 14
- •days before IMP administration:
- •a. Analgesics (including opioids) for HS related pain
- •b. Prescription-only topical therapies for HS
- •c. Oral anti-infectives for infections other than HS
- •10. History of moderate to severe heart failure (New York Heart
- •Association Class III or IV), cerebrovascular accident during the 24
- •weeks before Screening, history of malignancy except for successfully
- •treated non-metastatic basal cell or squamous cell carcinoma or in situ
- •carcinoma of the cervix
- •11. One of the following abnormal laboratory findings:
- •a. White blood cell count (WBC) < 2500/mm3
- •b. Neutrophil count < 1000/mm3
- •c. Serum creatinine > 3 × UNL
- •d. Total bilirubin > 3 × UNL
- •e. Alanine aminotransferase > 5 × UNL
- •f. Aspartate aminotransferase > 5 × UNL
- •g. Positive Screening test for HIV-1 or 2, or hepatitis B or C virus
- •12. Chronic and/or recurring systemic infections, history of invasive
- •infections with atypical pathogens (i.e., which normally do not cause
- •invasive infection, such as listeriosis), or known primary
- •immunodeficiency, as described in guidance provided to investigator
- •13. Subject is judged to be in poor general health, as determined by the
- •investigator based upon medical history, physical examination,
- •laboratory safety and, a 12 lead ECG
- •14. Female subjects of childbearing potential unwilling or unable to use
- •a highly effective method of contraception (pearl index < 1%) such as
- •complete sexual abstinence, combined oral contraceptive, vaginal
- •hormone ring, transdermal contraceptive patch, contraceptive implant,
- •or depot contraceptive injection in combination with a second method of
- •contraception such as condom, cervical cap, or diaphragm with
- •spermicide during the study and for at least 1 month after last
- •administration of IMP
- 另有 10 项未显示
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