EUCTR2008-004587-38-DE进行中（未招募）不适用
A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Hidradenitis Suppurativa
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects at least 18 years of age;
- •2. Subjects must have a diagnosis of HS for at least 6 months (180 days) prior to
- •Baseline that involves at least two distinct anatomic areas (e.g., left and right
- •axilla; or left axilla and left inguinal-crural fold);
- •3. Subjects must be unresponsive or intolerant, as determined by the investigator, to oral antibiotics for treatment for their HS;
- •4. Subject must have stable hidradenitis suppurativa for at least 2 months (60 days)
- •before Screening and also at the Baseline visit as determined by subject interview
- •of his/her medical history;
- •5. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is 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. The results of the serum pregnancy test performed during the Screening Period and urine pregnancy test performed at the Baseline Visit must be negative.
- •Examples of approved methods of birth control include the following:
- •? Barrier methods (condoms or intrauterine device)
- •? Contraceptives (oral, parenteral, transdermal or implantable) for three months
- •(90 days) prior to study drug administration
- •? Vasectomized partner
- •6. Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at
- •Screening (See Section 5.3.1.1 of the study protocol). If the subject had a positive PPD test (or equivalent), has had a past ulcerative reaction to PPD placement and/or a CXR consistent with prior TB exposure, the subject must initiate, or have documented completion of a course of anti-TB therapy; (See Section 5.3.1.1 of the protocol).
- •7. Subject has a PGA of at least moderate disease (score of = 3) at the Baseline visit;
- •8. Subject is judged to be in good general health, as determined by investigator based upon the results of a medical history, laboratory evaluations, chest x-ray (CXR), 12-lead ECG, and the physical examination performed during the Screening period and confirmed at Baseline;
- •9. Ability and willingness to self-administer SC injections or have available qualified
- •person(s) who can reliably administer SC injections;
- •10. Ability and willingness to give written informed consent and to comply with the
- •requirements of the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment with adalimumab or other anti-TNF therapy (e.g., infliximab or etanercept), or participation in an adalimumab trial;
- •2. Any other active skin disease or condition (e.g., bacterial, fungal or viral infection)
- •that may interfere with assessment of hidradenitis suppurativa;
- •3. Subjects on allowable oral and/or topical antibiotic treatment for HS who have
- •not been on a stable dose for at least 4 weeks prior to the Baseline visit.
- •(See Section 5.2.3 of the study protocol for medications).
- •4. Subject received systemic non-biologic therapies with potential therapeutic impact
- •for hidradenitis suppurativa < 4 weeks prior to Baseline visit (other than oral and/or topical antibiotics);
- •5. Received any investigational agent within 30 days or 5 half lives prior to Baseline
- •(whichever is longer), or within a duration of its known pharmacological activity;
- •6. Subject received UVB phototherapy within 2 weeks of Baseline;
- •7. Subject received PUVA phototherapy within 4 weeks of Baseline;
- •8. Prior exposure to Tysabri® (natalizumab);
- •9. Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or
- •IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals,
- •or oral antifungals within 14 days prior to Baseline; except as required as part of an anti-TB regimen;
- •10. History of moderate to severe congestive heart failure (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 CNS demyelinating disease or neurologic symptoms suggestive of CNS
- •demyelinating disease;
- •12. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
- •human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
- •chronic recurring infections or active TB;
- •13. Known hypersensitivity to the excipients of adalimumab as stated in the label;
- •14. Positive pregnancy test at Screening or Baseline;
- •15. Female subjects who are breast-feeding or considering becoming pregnant during the study;
- •16. Evidence of dysplasia or history of malignancy (including lymphoma and
- •leukemia) other than a successfully treated non-metastatic cutaneous squamous
- •cell, basal cell carcinoma or localized carcinoma in situ of the cervix;
- •17. History of clinically significant drug or alcohol abuse in the last 12 months;
- •18. Clinically significant abnormal screening laboratory results as evaluated by the Investigator;
- •19. 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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