NL-OMON39701已完成3 期
A Phase 3 Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Hidradenitis Suppurativa - M12-555
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AbbVie BV
- 入组人数
- 30
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) Subjects who previously participated in a prior Phase3 HS study (M11-810) and:
- •* completed the study, or
- •* achieved HiSCR at the entry of period B, then experienced a loss of response (LOR) defined as an AN count that is greater than the average of AN counts at baseline and week 12 of the prior Phase 3 HS study; or
- •* did not achieve HiSCR at the entry of period B, then experienced worsening or absence of improvement on or after week 16 of the prior phase 3 HS study, defined as an AN count * Baseline AN count at two consecutive visits (excluding week 12) occurring * 14 days apart
- •2) If female, subject is either:
- •* Not of childbearing potential, defined as postmenopausal for at least 1 year (365 days); or
- •* Surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy; or
- •* Of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug.
- •3) Subject must agree to daily use (throughout the entirety of the study) of one of the following over-the-counter topical antiseptics on their body areas affected with HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
排除标准
- •1. Prior treatment with any other anti-TNF therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 HS study.
- •2. Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of hidradenitis suppurativa.
- •3. Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit of Study M12-555, except for antibiotics permitted in a prior Phase 3 HS study.
- •4. Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.
- •5. Subject received systemic non-biologic therapies with potential therapeutic impact for HS < 28 days prior to Baseline visit of Study M12-555.
- •6. Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to the Baseline visit of Study M12-555, except for permitted analgesics taken in the prior Phase 3 HS study.
- •7. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Baseline visit other than investigational drug taken in a prior Phase 3 HS study.
- •8. Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
- •9. Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to the Baseline visit of Study M12-555 or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to the Baseline visit of Study M12-555, except as required as part of an anti-TB regimen or as permitted in a prior Phase 3 HS study.
- •10. History of moderate to severe congestive heart failure (New York Health Association [NYHA] class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator would put the subject at risk by participation in the protocol.
- •11. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- •12. History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV).
- •13. Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.
- •14. Chronic recurring infections or active TB.
- •15. Known hypersensitivity to adalimumab or its excipients as stated in Section 5.5.2, Table 3.
- •16. Positive pregnancy test at Baseline.
- •17. Female subjects who are breast-feeding or considering becoming pregnant during the study.
- •18. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ of the cervix.
- •19. History of clinically significant drug or alcohol abuse in the last 12 months (365 days).
- •20. Clinically significant abnormal laboratory results as evaluated by the investigator.
- •21. Subject is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.
研究者
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