A Phase 3, double-blind, placebo-controlled study evaluating efficacy and safety of riliprubart in participants with refractory chronic inflammatory demyelinating polyneuropathy - EFC17236

Sanofi-Aventis Research & Development0 个研究点目标入组 194 人开始时间: 2024年2月23日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 194

研究概览入排标准研究者记录与标识符相似试验

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

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021)., All participants must agree to use contraception methods during and after the study as required., Body weight within the range of 35 kg to 154 kg (77 to 340 lbs) at Screening, Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -- Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 55 weeks after the last dose of study medication: --- Refrain from donating or cryopreserving sperm PLUS --- Be abstinent from heterosexual intercourse (abstinent on a long term and persistent basis) and agree to remain abstinent OR --- Must agree to use contraception/barrier as detailed below: ---- A male condom and an additional highly effective contraceptive method as described in the protocol. -- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: --- Is a woman of nonchildbearing potential (WONCBP) as defined by the protocol OR --- Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, as described in Appendix 10.4 Contraception and barrier guidance during the study intervention period (to be effective before starting the intervention) and for at least 55 weeks after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period., Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee., Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.--Immunoglobulin-refractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening, defined as no clinically meaningful improvement or persistent INCAT score =2 after a minimum of: ---One dose of IVIg of 2 g/kg, followed by either a second dose of 2 g/kg, or at least 2 doses of 1 g/kg, with a separation of approximately 3 weeks between doses (each dose can be divided over 2 to 5 days), as indicated in the EAN/PNS 2021 guidelines OR ---SCIg maintenance therapy with at least 0.2 g/kg weekly for 5 weeks --Corticosteroid-refractory subgroup: Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening, defined as no clinically meaningful improvement or persistent INCAT score =2 after a minimum of 12 weeks of corticosteroid therapy. Corticosteroid regimen can be daily oral prednisone/prednisolone, at least 60 mg, equivalent to methylprednisolone 48 mg, tapered over 6 to 8 months, or alternative regimens, e.g. pulsed high-dose corticosteroid treatment (40 mg/day oral dexamethasone or 500 mg/day IV methylprednisolone, each daily for 4 days per month for 6 months), as indicated in the EAN/PNS 2021 guidelines A clinically meaningful improvement is defined as one or more of the following: ---A =1 point decrease in adjusted INCAT dis

排除标准

•Polyneuropathy of other causes, including but not limited to: acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to Immunoglobulin M (IgM) monoclonal gammopathy, POEMS syndrome, and lumbosacral radiculoplexus neuropathy., Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse, Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk, Participant has received immunoglobulins (IVIg or SCIg) within 12 weeks prior to Screening, Treatment with plasma exchange within the 8 weeks prior to Screening, Prior treatment with riliprubart, Prior treatment with (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine, Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation, Prior treatment with B-cell-depleting agents such as rituximab within 6 months prior to riliprubart dosing, or before B-cell counts return to normal levels, whichever is longer, Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening, Treatment within 6 months prior to dosing with immunosuppressive/ chemotherapeutic medications, such as cyclophosphamide, methotrexate, tacrolimus, interferon, or tumor necrosis factor (TNF)-a inhibitors. Certain immunosuppressants commonly used in CIDP (azathioprine, cyclosporine, or mycophenolate mofetil) are allowed, as indicated under inclusion criterion., Sensory CIDP, Distal CIDP and focal CIDP variants., Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening), Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening, Any screening laboratory values outside normal limits or abnormal ECG considered in the Investigator’s judgment to be clinically significant in the context of this trial., Positive result of any of the following tests: --hepatitis B surface antigen (HBsAg) --anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies [anti-HBs Ab] are also positive, indicating natural immunity) --anti-hepatitis C virus (anti-HCV) antibodies --anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies, Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation, Accommodation in an institution because of regulatory or legal order; eg, imprisoned or legally institutionalized, Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potential risk for noncompliance to study procedures, Participants are employees at the clinical study site or other individuals directly involved in the conduct of the study, or immediate family member of such individuals, Any country related specific regulation that would prevent the participant from entering the study, Any other neurological or systemic disease that can c

研究者

发起方

Sanofi-Aventis Research & Development

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