EUCTR2006-005455-15-GB进行中（未招募）1 期
A three-part multicenter study, with a randomized, doubleblind, placebo controlled, withdrawal design in Part II to assess efficacy, safety, and tolerability of ACZ885 (antiinterleukin-1ß monoclonal antibody) in patients with Muckle-Wells Syndrome - CACZ885D2304
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
入选标准
- •1. Male and female patients aged 4 to 75 years at the time of the screening visit.
- •2. Patient's informed consent for less than 18 years of age
- •3. Patient or legal guardian's written informed consent and child's assent, if appropraite, are required prior to study participants under the age of 18 years.
- •4.Molecular diagnosis of NALP3 mutations and clinical picture resembling MWS.
- •5. MWS patients who participated in the CACAZ8852102 study, will have the option to participate in this study upon flare (see Study design Section 4).
- •6. For patients under anakinra therapy or any other investigational IL-1 blocking therapy, willingness to discontinue the treatment.
- •7. Female subjects must be either
- •-Surgically sterilised or hysterectomized at least 6 months prior to screening.
- •-Postmenopausal i.e. must have no regular menstrual bleeding for at least 1 yr
- •prior to inclusion
- •-Women of childbearing potential must be using an effective method of
- •contraception.
- •8. Body weight greater than 15 kg and less than 100kg
- •9. Able to communicatewith the investigator and comply with requirements of the study
- •Are the trial subjects under 18? yes
- •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. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation with the exception of trials with anakinra, investigational IL-1 blocking theapy and the CACACZ885A2102 study.
- •2. Use of the following therapies:
- •Etanercept in the 4 weeks prior to the baseline visit (Day 1)
- •Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
- •Infliximab in the 12 weeks prior to the baseline visit (Day 1)
- •Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1) (with the exception of anakinra therapy and IL-1 blocking therapies –see below)
- •Patients who are on IL-1 blocking biological therapies (including anakinra therapy) need to discontinue this treatment. As soon as the criteria for relapse are fulfilled, patients can enter the study and receive ACZ885 treatment. This run-in phase reduces the classical wash-out phase to a medically meaningful time and avoids unnecessary suffering for the patient in case a predefined wash-out period per protocol is too long for an individual subject.
- •Leflunomide in the 4 weeks prior to the baseline visit (Day 1)
- •Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
- •Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
- •i.v. immunoglobulin (i.v. Ig) in the 8 weeks prior to the baseline visit (Day 1)
- •6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
- •Colchicine, dapsone, mycophenolate mofetil in the 3 weeks prior to the baseline visit (Day 1)
- •Corticosteroids =20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
- •3. Donation of loss of 400 mL or more of blood within 8 weeks prior to dosing for adults (see appendix 9 for total volume for children)
- •4. Past medical history of clinically significant abnormalities or a familly history of a prolonged QT-interval syndrome
- •5. History of being immunocompromised, including HIV at screening
- •6. A positive Hepatitis B surface antigen
- •7. No live vaccinations within 3 mths prior to start of trial, during trial and up to 3 mths following last dose.
- •8. History of alcohol abuse within 12 mths prior to dosing
- •9. History of significant medical conditions, which in the investigators opinion would exclude the patient from participating
- •10. History of recurrent and/or evidence of active naterial, fungal or viral infections.
- •11. Positive tuberculin skin test reaction.
研究者
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