NCT06752356招募中3 期
A Double-blind, Randomized, Multi-Center Study Investigating Efficacy and Safety of Two Different Dosages of Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Kedrion S.p.A.5 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 161
- 试验地点
- 5
- 主要终点
- Efficacy of 1.0 g/kg KIg10 in the treatment of adult subjects with active CIDP
研究概览
简要总结
The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.
详细描述
This is a Double Blind, Randomized study. All subjects will enter a wash-out phase of up to 12 weeks, or until functional deterioration, defined as an increase of ≥1 point (worsening) in the adjusted INCAT disability score, is demonstrated. Eligible subjects will then be randomized in a 1:2 ratio to receive either 0.5 g/kg or 1.0 g/kg KIg10 at 3-weekly intervals for 21 weeks. Subjects who relapse during randomized treatment due to functional deterioration, based on the INCAT score, will be rescued with 2.0 g/kg KIg10 at 3-weekly intervals for 21 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Sponsor will also be masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18 years.
- •Written informed consent and authorization to access personal health information obtained independently from participants indicating that they understand the purpose of, and procedures required for, the study and are willing to participate.
- •Documented diagnosis of CIDP consistent with the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria.
- •Current or documented history of significant disability, as defined by an overall INCAT disability score between 2 and
- •A score of 2 must be exclusively from the lower extremities.
- •Participants are currently dependent on treatment with immunoglobulins, corticosteroids, or standard of care treatments for CIDP.
- •Weakness of at least two limbs.
- •Participants should be clinically stable 12 weeks prior to screening date as defined by:
- •without a worsening in INCAT score of ≥1 point, AND/OR without significant changes in clinical symptoms AND
- •without significant dose changes or requiring additional treatments.
排除标准
- •Patients' incapable of giving informed consent.
- •Pure sensory and other CIDP variants.
- •Females who are pregnant, breastfeeding, unwilling to practice effective birth control methods as defined in Appendix C throughout the study, or planning a pregnancy during the study.
- •IG-experienced participants requiring an IGIV dosage of more than 1.4 g/kg/month OR SCIG pre-treated participants requiring a SCIG dosage of more than 1.6 g/kg/month.
- •Participants who have previously failed to respond to IGIV or SCIG.
- •On screening date, a body mass index (BMI) > 35 kg/m2 or an IGIV dose that puts the patient at risk of fluid overload.
- •CIDP and any neuropathy of other causes not consistent with the 2021 EAN/PNS criteria including:
- •Hereditary demyelinating neuropathies, such as a hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), and hereditary sensory and autonomic neuropathies (HSANs).
- •Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexopathy or neuropathy, lymphoma, and amyloidosis.
- •Multifocal motor neuropathy (MMN).
- •Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy. Peripheral neuropathy induced by vitamin B12 deficiency.
- •Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with increased titers of antibodies to myelin-associated glycoprotein.
- •Central demyelinating disorders (e.g, multiple sclerosis) or severe myopathy.
- •Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (e.g., severe arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) [participants with clinically diagnosed diabetes mellitus, who have adequate glycemic control with Hemoglobin A1C (HbA1C) of <7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed].
- •Congestive heart failure (New York Heart Association (NYHA) Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension [i.e., diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.
- •History of deep vein thrombosis or thromboembolic events (e.g, cerebrovascular accident, pulmonary embolism) in the past 12 months.
- •Condition(s) which could alter protein catabolism and/or IgG utilization (e.g, protein-losing enteropathies, nephrotic syndrome).
- •Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 milliliter per minute per 1.73 square meter (mL/min/1.73m2) estimated based on an established chronic kidney disease epidemiology collaboration (CKD-EPI) equation at the time of screening.
- •Active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.
- •Hypersensitivity or adverse reactions (e.g, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components.
- •Known history of immunoglobulin A (IgA) deficiency.
- •Known history of autoimmune nodo-paranodopathies causing IG treatment resistance, including anti-neurofascin (NF) 186 antibodies and antibodies against paranodal proteins, such as NF155, contactin 1 (CNTN1), and contactin-associated protein 1 (CASPR1).
- •Abnormal laboratory values at screening:
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN)
- •Platelet count <100,000 cells/µL.
- •Absolute neutrophil count (ANC) <1000 cells/µL.
- •Clinically significant anemia or hemoglobin (Hgb) level of < 10.0 g/dL at screening.
- •Ongoing/active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV Type 1/2 infection. Participants with chronic hepatitis B or hepatitis C infection currently on treatment may participate if they have undetectable viral load within 12 months of screening date.
- •Subjects who have received:
- •Within 2 months before wash-out phase:
- •change in treatment of methotrexate, azathioprine, or mycophenolate
- •Within 3 months before wash-out phase: Efgartigimod alfa (Vyvgart)
- •Within 5 months before wash-out phase: cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or any other immunosuppressive medications
- •Within 12 months before wash-out phase: rituximab or alemtuzumab
- •Participants who have received a hematopoietic stem cell transplant.
- •Participants on corticosteroids for the treatment of CIDP after being fully washed out. Participants on maintenance doses of corticosteroid may be allowed, if treatment is for conditions unrelated to CIDP (doses usually below 20 mg/day prednisone or equivalent and where the dosage is unlikely to be tapered during the duration of the trial may be allowed for indications other than CIDP).
- •Any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study.
- •Participation in another clinical study involving an investigational medicinal product (IMP) or investigational device within 30 days prior to screening visit or within 5 half-lives of the IMP under investigation or is scheduled to participate in another clinical study involving an IMP or investigational device during the intended course of this study.
- •History of acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of developing thrombotic events. Examples include, but are not restricted to:
- •Hereditary thrombophilia, examples include
- •Factor V Leiden mutation.
- •Prothrombin 20210A mutation.
- •Protein C deficiency.
- •Protein S deficiency.
- •Antithrombin deficiency.
- •Acquired thrombophilias, examples include:
- •Antiphospholipid antibody syndrome.
- •Activated protein C Resistance acquired.
- •Homocysteinemia.
- •Previous participation in this clinical study, except for participants who withdrew consent during the washout phase, prior to randomization.
- 另有 1 项未显示
研究组 & 干预措施
1.0 g/kg dose group for 24 weeks
Experimental
This group will receive, initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion followed by 1.0 g/kg of IV KIg10 every 3 weeks.
干预措施: Immune globulin (human) 10% solution for intravenous administration (Biological)
0.5 g/kg dose group for 24 weeks
Experimental
This group will receive, Initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion will be given followed by 0.5 g/kg of IV KIg10 every 3 weeks.
干预措施: Immune globulin (human) 10% solution for intravenous administration (Biological)
结局指标
主要结局
Efficacy of 1.0 g/kg KIg10 in the treatment of adult subjects with active CIDP
时间窗: From Baseline upto 24 weeks of treatment
The proportion of responders in the 1.0 g/kg KIg10 arm, at week 24 relative to Randomization Baseline week 0, based on the adjusted INCAT disability score. A responder is defined as having a ≥1 point decrease (improvement) in the adjusted INCAT score at week 24 relative to adjusted INCAT score at randomization baseline.
次要结局
- Efficacy of 0.5 g/kg KIg10 in the treatment of adult subjects with active CIDP(From Baseline upto 24 weeks of treatment)
- Proportion of responders (Week 24 vs Baseline) in both dose groups(From Baseline upto 24 weeks of treatment)
- Proportion of responders in rescued subjects(End of Treatment vs onset of rescue treatment)
- Improvers based on the MRC-sumscore(From Baseline upto 24 weeks of treatment)
- Mean Change in MRC-sumscore(From Baseline upto 24 weeks of treatment)
- Mean Change in MRC-sumscore for rescued subjects(End of Treatment vs onset of rescue treatment)
- Disease Related QoL (CAPPRI) for each dose level(From Baseline upto 24 weeks of treatment)
- Mean change in I-RODS(From Baseline upto 24 weeks of treatment)
- Mean change in I-RODS for rescued subjects(End of Treatment vs onset of rescue treatment)
研究者
研究点 (5)
Loading locations...
相似试验
招募中
3 期
Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic DermatitisAtopic DermatitisNCT06026891Shanghai Mabgeek Biotech.Co.Ltd498
终止
2 期
Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal TransplantationKidney Transplantation (Status Post)NCT02723786GlaxoSmithKline7
已完成
2 期
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)Acquired Immunodeficiency SyndromeHIV InfectionsNCT00100048Merck Sharp & Dohme LLC206
已完成
2 期
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus BacteremiaStaphylococcus Aureus BacteremiaStaphylococcus Aureus EndocarditisNCT03163446ContraFect121
已完成
1 期
Study to Test Safety, Tolerability and Blood Levels of GSK971086 After 1 Dose & 7 Days of Dosing in Healthy Adult MalesHealthy SubjectsAndrogen DeficiencyNCT00540553GlaxoSmithKline126