PER-033-22尚未招募3 期
A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-2)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Immunic AG
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
- 性别
- All
入选标准
- •Inclusion Criteria for the Main Period of the Study
- •1. Male or female patient (age =18 to =55 years).
- •2. Patients with an established diagnosis of MS according to 2017 McDonald Criteria [32].
- •3. Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary
- •progressive MS, both defined according to Lublin criteria 1996 and 2014.
- •4. Active disease as defined by Lublin 2014 [18] evidenced prior to Screening by:
- •a. At least 2 relapsesa in the last 24 months before randomization, or
- •b. At least 1 relapsea in the last 12 months before randomization [18], or
- •c. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to
- •randomization.
- •5. EDSS score between 0 and 5.5 (inclusive) at SV1.
- •6. Female patients:
- •a. must be of non-childbearing potential, ie, surgically sterilized (hysterectomy,
- •bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before SV1) or
- •postmenopausal (where postmenopausal is defined as no menses for 12 months
- •without an alternative medical cause), or
- •b. if of childbearing potential, must have a negative pregnancy test at SV1 (blood test)
- •and before the first IMP intake (Day 1 blood or urine test). They must agree not to
- •attempt to become pregnant, must not donate ova, and must use a highly effective
- •contraceptive method (see below) together with a barrier method between study
- •consent and 30 days after the last intake of the IMP.
- •c. highly effective forms of birth control are those with a failure rate less than 1% per
- •year and include:
- •i. oral, intravaginal, or transdermal combined (estrogen and progestogen
- •containing) hormonal contraceptives associated with inhibition of ovulation.
- •ii. oral, injectable, or implantable progestogen-only hormonal contraceptives
- •associated with inhibition of ovulation.
- •iii. intrauterine device or intrauterine hormone-releasing system.
- •iv. bilateral tubal occlusion.
- •v. vasectomized partner (ie, the patient’s male partner underwent effective
- •surgical sterilization before the female patient entered the clinical study and
- •is the sole sexual partner of the female patient during the clinical study).
- •vi. sexual abstinence (acceptable only if it is the patient’s usual form of birth
- •control/lifestyle choice; periodic abstinence [eg, calendar, ovulation,
- •symptothermal, postovulation methods] and withdrawal are not acceptable
- •methods of contraception).
- •d. Barrier methods of contraception include:
- •ii. occlusive cap (diaphragm or cervical/vault caps) with spermicidal
- •gel/film/cream/suppository.
- •7. Male patients must agree not to father a child or to donate sperm starting at SV1,
- •throughout the clinical study, and for 30 days after the last intake of the IMP. Male
- •patients must also:
- •a. abstain from sexual intercourse with a female partner (acceptable only if it is the
- •patient’s usual form of birth control/lifestyle choice), or
- •b. use adequate barrier contraception during treatment with the IMP and until at least
- •30 days after the last intake of the IMP, and
- •c. if they have a female partner of childbearing potential, the partner should use a
- •highly effective contraceptive method as outlined in inclusion criterion 5.
- •d. if they have a pregnant partner, they must use condoms while taking the IMP to
- •avoid exposure of the fetus to the IMP.
- 另有 2 项未显示
排除标准
- •Exclusion Criteria for the Main Period of the Study
- •MS-related exclusion criteria:
- •1. Patients with non-active secondary progressive MS and primary progressive MS.
- •2. Any disease other than MS that may better explain the signs and symptoms, including
- •history of complete transverse myelitis.
- •3. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica
- •(NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgGassociated
- •encephalomyelitis.
- •4. Any MRI finding, which puts in question the MS diagnosis, including but not limited to a
- •longitudinally extensive spinal cord lesion.
- •5. History of malignancy of any organ system (other than localized basal cell carcinoma of
- •the skin or adequately treated cervical cancer), treated or untreated, within the past 5 years,
- •regardless of whether there is evidence full remission at the current time.
- •6. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for
- •type 1 diabetes mellitus and inflammatory bowel disease).
- •7. An MS relapse ending within 30 days before SV1 and/or during the Screening Period
- •(until Day 1).
- •8. Any corticosteroid treatment for relapse given within 30 days before SV2.
- •And other exclusion criteria defined in the
- •protocol, check section 9.2.1.2 for more
- •Therapy exclusion criteria
- •Immune response exclusion criteria
- •Other medical history and concomitant disease exclusion criteria
- •General exclusion criteria
- •Exclusion Criteria for the Extension Period of the Study, Open-Label Treatment
- •1. Any ongoing, clinically significant (as assessed by the investigator) TEAE (started after
- •intake of IMP) or laboratory abnormality (including blood chemistry and urinalysis) that,
- •upon discretion of the investigator, should prohibit further treatment with study medication
- •in this trial.
- •2. Significant treatment non-compliance (defined as having taken <70% of study medication)
- •or study non-compliance during the MP (as assessed by the investigator, in consultation
- •with the medical monitor), and/or inability or unwillingness to follow instructions by study
- •3. Multiple significant protocol deviations during the MP that are assessed by the
- •investigator, in consultation with the medical monitor, to negatively affect further patient
- •cooperation in this study.
- •4. Use of experimental/investigational drug (with the exception of COVID-19 vaccines approved by emergency use authorization) and/or participation in another clinical trial of
- •an investigational drug throughout the duration of the EP open-label treatment period.
研究者
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