CTIS2022-502370-17-00进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, proof of concept study assessing the efficacy and safety of an anti-TNF-OX40L NANOBODY® molecule, SAR442970, in participants with moderate to severe hidradenitis suppurativa - ACT16852
Sanofi-Aventis Research & Development0 个研究点目标入组 84 人开始时间: 2023年3月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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
- •Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to baseline., Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III, Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history, Participants must be either biologic and small molecule immunosuppressive-naïve or TNF-experienced, Participant must have a total abscess and inflammatory nodule (AN) count of =3 at the baseline visit, Participant must have a draining tunnel count of =20 at the baseline visit, Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit, Participant who is a candidate for systemic treatment per Investigator’s judgment
排除标准
- •Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that may interfere with assessment of HS, History of solid organ transplant, History of splenectomy, History of moderate to severe congestive heart failure, Receipt of a live vaccine 12 week prior to baseline visit or receipt of a killed vaccine 2 weeks prior to baseline visit, History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured, Laboratory exclusion criteria apply, Participants with a diagnosis of inflammatory conditions other than HS, Presence of active suicidal ideation, or positive suicide behavior or participant has a lifetime history of suicide attempt, or participant has had suicidal ideation in the past 6 months as indicated by a positive response using the screening or baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history, A history of an adverse event (AE) to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate re administration of an anti-TNF class therapy, Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study, Female participants who are breastfeeding or considering becoming pregnant during the study, History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator, History of recurrent or recent serious infection, Known history of or suspected significant current immunosuppression
研究者
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