EUCTR2020-004006-54-IT进行中（未招募）1 期
A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) - NA
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 90 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •-Adults>/=18yrs of age at the time of signing informed consent.
- •-Documented definite or probable diagnosis of CIDP(typicalCIDP,pure motorCIDP,Lewis-Sumner Syndrome)according to EFNS/PNS Task Force first revision
- •-Belonging to 1 of the following 3 groups:standard-of-care(SOC)-Treated,SOC-Refractory,SOC-Naïve,as defined below
- •-SOC-Treated(all criteria a-c must be met):
- •a)Documented evidence of objective response to SOC,with clinically meaningful improv. Clinically meaningful improv is defined as one of the following:>/=1-point decrease in adj INCAT score,>/=4points increase in RODS total score,>/=3points increase in MRC Sum score,>/=8kilopascal improv in mean grip strength(one hand),or an equivalent improv based on information documented in medical records and per the PI's judgement
- •b)Must be on stable SOC therapy, defined as no change greater than 10% in frequency or dose of immunoglobulin therapy or CS within 8wks prior to screen,remaining at stable SOC therapy until the time of first BIVV020 dosing
- •c)Evidence of clinically meaningful deteriorat on interruption or dose reduct of SOC therapy within 24mths prior to screen,determined by clinical examination or medical records.Clinically meaningful deterioration is defined as one of the following:>/=1-point increase in adj INCAT score, decrease in RODS total score>/=4points, decrease in MRC Sum score>/=3,mean grip strength worsening of>/=8kilopascals(one hand),or an equivalent deterioration based on information from medical records and at the PI's judgement
- •-SOC-Refractory(all criteria a-d must be met):
- •a)Evidence of failure or inadequate response to SOC defined as no clinically meaningful improv and persistent INCAT score>/=2after treatment for a min of 12wks on SOC prior to screen. A clinically meaningful improv is defined as one of the following:>/=1-point decrease in adj INCAT score, increase in RODS total score>/=4points, increase in MRC Sum score>/=3,mean grip strength improv of>/=8kilopascals(one hand), or equivalent improv based on information from medical records and at the PI's judgement.Or Unable to receive or continue treatment with immunoglobulins or CS due to side effects
- •b)Patient has not received IGs(IVIg or SCIg)within12wks prior to screen
- •c)Certain immunosuppressant drugs are allowed in this group if taken for>/=6mths and at a stable dose for>/=3mths prior to screen: azathioprine,methotrexate,mycophenolate mofetil,cyclosporine.Oral CS are allowed if on a stable dose of<20mg/day of prednisone(or equivalent dose for other oral CS) fo =3mths prior to screen
- •d)INCAT score:2-9(a score of 2 should be exclusively from leg disability component of INCAT)
- •-SOC-Naïve(all criteria a-c must be met):
- •a)Participants without previous treatment for CIDP or participants who received IGs(IVIg or SCIg) or CS but were stopped for reasons other than lack of response or side effects
- •b)Not treated with immunoglobulins (IVIg or SCIg) or CS for at least 6mths prior to screen
- •c)INCAT score:2-9(a score of 2 should be exclusively from leg disability component of INCAT
- •-Documented vaccin against encapsule bacterial pathogens given within 5yrs of enrollment or initiated a min of 14days prior to first dose
- •-Female participant must use a double contracept method including a highly effective method of birth control from inclusion and up to 52wks plus 30days after the last study dose and agree not to donate eggs,ova,oocytes during this period
- •-Female participant must have a negative highly sensitive p
排除标准
- •1.Polyneuropathy of other causes, including but not limited to hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, monoclonal gammopathy of uncertain significance, lumbosacral radiculoplexus neuropathy, pure sensory CIDP and acquired demyelinating symmetric (DADS) neuropathy (also known as distal CIDP).
- •2.Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.
- •3.Poorly controlled diabetes (HbA1c >7%).
- •4.Serious infections requiring hospitalization within 30 days prior to screening and any active infection requiring treatment during screening.
- •5.Clinical diagnosis of SLE.
- •6.Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to BIVV020 or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.
- •7.Presence of conditions (medical history or laboratory assessments) that may predispose the participant to excessive bleeding or increased risk of infection.
- •8.A history of CIDP relapse after prior vaccination.
- •9.Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.
- •10.Treatment with plasma exchange within 12 weeks prior to screening.
- •11.Prior treatment with rituximab or ocrelizumab in the 6 months prior to BIVV020 dosing or until return of B-cell counts to normal levels, whichever is longer.
- •12.Immunosuppressive/chemotherapeutic medications such as azathioprine, methotrexate, cyclophosphamide, cyclosporine, mycophenolate mofetil, tacrolimus, interferon, TNF-alpha inhibitor: within 6 months prior to dosing (except for some cases as indicated in the SOC-Refractory group).
- •13.Treatment (any time) with highly immunosuppressive/chemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine.
- •14.Treatment (any time) with total lymphoid irradiation or bone marrow transplantation.
- •15.Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer, prio to screening.
- •16.Pregnant (defined as positive ß-HCG blood test) or lactating females.
- •17.Positive result on any of the following tests: hepatitis B surface (HBsAg) antigen,antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 antibodies).
- •18.Evidence of IgG4 autoantibodies against paranodal proteins (NF155And CNTN1).
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