JPRN-jRCT2031210308已完成2 期
A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa.
ishikawa Kazuko0 个研究点目标入组 151 人开始时间: 2021年9月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
研究概览
简要总结
Bermekimab showed numerically high response in the reduction of inflammatory nodule and draining fistula counts but did not result in statistically significant increase in HiSCR50 responder as compared to placebo at Week 16. The study met its prespecified futility criteria; hence, the decision was made to terminate this study. Bermekimab 1050 mg was well tolerated in participants with HS; however, it showed numerically higher incidence of infections and infestations and injection site reactions.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •- Have hidradenitis suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history
- •- Have Hurley Stage II or Hurley Stage III HS as determined by the investigator at screening and baseline visits
- •- Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold) at screening and baseline visits
- •- Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=)5 at the screening and baseline visit
- •- Agree not to receive a live virus or live bacterial vaccination during the study and for 90 days after the last administration of study intervention
排除标准
- •Exclusion Criteria:
- •- Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •- Has unstable cardiovascular disease, defined as a recent clinical deterioration (that is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- •- Has or has had herpes zoster within the 2 months before screening
- •- Has a transplanted organ (with exception of a corneal transplant greater than [>]3 months before the first administration of study intervention)
- •- Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or its excipients
研究者
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