CTIS2022-503160-33-00进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa - 22107
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •2. Subject must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age and above, at the time of signing the informed consent. 4. Hidradenitis suppurativa lesions present in = 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguino-crural fold), one of which is Hurley Stage II or Hurley Stage III at screening and Day 1 prior to enrollment/randomization. 5. A total AN count of = 5 at screening and Day 1 prior to enrollment/randomization. 6. Subject must have had an inadequate response to oral antibiotics (defined as = 3-month treatment with an oral antibiotic for treatment of HS) OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS as assessed by the investigator through subject interview and review of medical history. 10. Subject has a negative TB test at screening
排除标准
- •3. Other active skin disease or condition (eg, bacterial, fungal or viral infection) that could interfere with study assessments. 4. History of active IBD OR Any of the following symptoms (of unknown etiology) or any signs or symptoms within the last year that in the opinion of the investigator may be suggestive of IBD, with fecal calprotectin > 500 µg/g; OR if fecal calprotectin > 150 to < 500 µg/g without confirmed approval from a gastroenterology consultation that an IBD diagnosis is clinically unlikely (see Section 8.2.10) when the following clinical signs and symptoms are present: a. prolonged or recurrent diarrhea b. prolonged or recurrent abdominal pain c. blood in stool 9. Risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening. Subjects with major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication. If on medication for major depressive disorder, subjects must have been on a stable antidepressant dose for at least 3 months prior to the first dose of study drug and agree to continue for the duration of the study or as indicated by their treating psychiatrist. 10. History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. 11. Active infection or history of infection as follows: a. Any active infection for which oral anti-infectives (antibiotics, antivirals, antifungals) were used = 14 days prior to first dose of study drug (except for the use of a stable dose allowable antibiotics [doxycycline or minocycline only] for HS). b. A serious infection requiring hospitalization or IV anti-infectives (antibiotics, antivirals, antifungals) = 30 days prior to first dose of study drug. c. Recurrent or chronic infections or other active infections that in the opinion of the investigator might cause this study to be detrimental to the subject. 12. Candida infection requiring systemic treatment within 3 months prior to first dose of study drug. 13. Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved). 15. Previous exposure to izokibep or any other IL-17 inhibitor and IL-17 receptor inhibitors (eg, secukinumab, ixekizumab, bimekizumab, brodalumab).
研究者
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