LBCTR2023115324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-1) - ENSURE 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Immunic AG
- 入组人数
- 1,050
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 55（—）
- 性别
- All
入选标准
- •1. Male or female patient (age =18 to =55 years).
- •2. Patients with an established diagnosis of MS according to 2017 McDonald Criteria .
- •3. Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.a
- •a Patients are eligible for this trial if their disease modifying treatment has failed due to efficacy, safety, or tolerability issues, if they have contraindications or no access to treatment, or if they refuse the offered MS treatment.
- •4. Active disease as defined by Lublin 2014 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 , or
- •c. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to
- •randomization.
- •aRelapses must have been assessed and documented by a physician in the patient files.
- •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 us
排除标准
- •Exclusion Criteria for the Main Period of the Study
- •Multiple sclerosis-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)-IgG-associated 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.
- •Therapy exclusion criteria:
- •9. Use of experimental/investigational drug (with the exception of COVID-19 vaccines
- •approved by emergency use authorization) within 8 weeks or 5 times the respective half-life before the date of informed consent, whichever is longer, and throughout the duration of the study; and/or participation in drug clinical studies within 6 months prior to Screening (For selected approved marketed products, if used as an investigational drug, exclusion criterion 11 applies).
- •10. Any previous treatment with:
- •a. total lymphoid irradiation
- •b. bone marrow transplantation
- •c. stem cell transplantation
- •d. cladribine, alemtuzumab, or belimumab, including their biosimilars
- •Lifelong:• cyclophosphamide
- •mitoxantrone, if cumulative life-time dose >60 mg/m² or if
- •evidence of cardiotoxicity following mitoxantrone treatment
- •Within 12 months:• any use of DHODH inhibitors, including teriflunomide or leflunomide
- •anti-CD 19/20 (ocrelizumab, rituximab, ofatumumab, including their biosimilars and investigational products)
- •mitoxantrone
- •daclizumab
- •Within 6 months:• natalizumab
- •calcineurin inhibitors (eg, tacrolimus, cyclosporine, or pimecrolimus)
- •immunoglobulins
- •azathioprine
- •Within 3 months: • plasmapheresis
- •any cytokine (other than interferon) or anti-cytokine therapy
- •methotrexate
- •Sphingosine-1-receptor (S1P) modulators (including, but not limited, fingolimod, siponimod, and ozanimod)
- •Tofactinib
- •mycophenolate mofetil or mycophenolate sodium
- •recurrent pulsed intravenous or intrathecal corticosteroid treatments.
- •Within 30 days• dimethyl fumarate, monomethyl fumarate, and diroximel fumarate
- •slow-release (pegylated) forms of interferons or depot formulations of glatiramer acetate
- •Within 7 days• interferon-ß
- •glatiramer acetate
- •12. Any use of adrenocorticotrophic hormone (ACTH) or occasional use of systemic corticosteroids (oral or intravenous) 30 days before SV2.
- •13. Any use of the following concomitant medications is prohibited during Screening and
- •throughout the duration of the study:
- •a. any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad, as well as uricosuric drugs such as probene
研究者
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