EUCTR2016-001448-21-BG进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participants with a diagnosis of RMS (may include participants with
- •SPMS with superimposed relapses provided they meet the other criteria)
- •in accordance with revised McDonald criteria for MS and Lublin and
- •2. Male or female aged 18 to 65 years
- •3. One or more documented relapses within the 2 years before Screening
- •with either: a) One relapse which occurred within the last year prior to
- •randomization or b) the presence of at least 1 Gd+ T1 lesion within 6
- •months prior to randomization would make the patient eligible.
- •4. EDSS score of 0 to 6 at Baseline
- •5. Women of childbearing potential must use a supplementary barrier
- •method together with a highly effective method of contraception for 4
- •weeks prior to randomization, throughout the trial, and for 90 days after
- •the last dose of IMP. Male subjects and their female partners must also
- •use the above.
- •6. Signed and dated informed consent (participant must be able to
- •understand the informed consent) indicating that the participant has
- •been informed of all the pertinent aspects of the trial prior to enrolment
- •and will comply with the requirements of the protocol.
- •For the open-label extension period;
- •Participants who have withdrawn after randomization (eg, due to AEs or
- •lack of efficacy) will not be replaced and will not be eligible to
- •participate in the OLE Period. Only participants who have completed the
- •48-week main study are eligible to participate.
- •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 248
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Progressive MS
- •Disease duration > 15 years in participants with EDSS of 2 or less
- •Use of the following, as determined in the protocol ; rituximab,
- •ocrelizumab, mitoxantrone, or lymphocyte-depleting therapies,
- •lymphocyte trafficking blockers (eg, natalizumab, fingolimod), IV Igs,
- •plasmapheresis, immunosuppressive treatments, B-interferons or
- •glatiramer acetate, Systemic glucocorticoids, teriflunomide, daclizumab
- •Exposure to Tecfidera within 6 months prior to randomization
- •Any allergy, contraindication, or inability to tolerate Tecfidera
- •Treatment with dalfampridine (fampridine, Ampyra) unless on a stable
- •dose for = 30 days prior to randomization
- •Inability to comply with MRI scanning
- •Immunologic disorder other than MS, with the exception of secondary
- •well-controlled diabetes or thyroid disorder, or any other condition
- •requiring oral, IV, intramuscular, or intra-articular corticosteroid therapy
- •Vaccination with live or live-attenuated virus vaccine within 1 month
- •prior to Screening
- •Severe drug allergy or history of anaphylaxis, or allergy to the IMP or
- •any of its incipients
- •Active, clinically significant viral, bacterial, or fungal infection, or any
- •major episode of infection requiring hospitalization or treatment with
- •parenteral anti-infectives within 4 weeks of Screening, or completion of
- •oral anti-infectives within 2 weeks before or during Screening, or a
- •XML File Identifier: k4hJyQ2TTXfK1h/jRu7hSMCeZdA=
- •history of recurrent infections (ie, 3 or more of the same type of
- •infection in a 12-month rolling period). Vaginal candidiasis,
- •onychomycosis, and genital or oral herpes simplex virus considered by
- •the Investigator to be sufficiently controlled would not be exclusionary.
- •History of or positive testing for HIV, HCV antibody and/or polymerase
- •chain reaction,HBsAg (+) and/or hepatitis B core total, and/or IgM
- •antibody (+) at Screening.
- •The participant: • Has a history of or current diagnosis of active
- •tuberculosis (TB) or • Is currently undergoing treatment for latent TB
- •infection (LTBI) or • Has an untreated LTBI or • Has a positive
- •QuantiFERON®-TB test at Screening.
- •Indeterminate QuantiFERON
- •Participants with current household contacts with active TB will also
- •be excluded
- •History of splenectomy or any major surgery within 2 months prior to
- •History of myocardial infarction or cerebrovascular event as per the
- •History of attempted suicide within 6 months prior to Screening or a
- •positive response to items 4 or 5 of C-SSRS
- •An episode of major depression within the last 6 months prior to
- •On anticoagulation, fish oil supplements, or antiplatelet therapy other
- •than daily aspirin for cardioprotection and treatment of Tecfidera
- •induced flushing
- •History of cancer, except adequately treated basal cell or squamous
- •cell carcinoma of the skin
- •Breastfeeding/lactating or pregnant women
- •Participation in any investigational drug trial within 1 month or 5 halflives
- 另有 10 项未显示
研究者
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