NCT05327114招募中2 期
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 199
- 主要终点
- Stage B: Time to First Occurrence of a Relapse Event
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.
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)
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
- •Adults greater than or equal to (>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place
- •Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period
- •Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score
- •Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (>) 20 mg/day and the participant is willing to taper to <=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
- •Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3
- •Other protocol-defined inclusion criteria will apply
排除标准
- •Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results
- •Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
- •Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
- •Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee
- •Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- •Other protocol-defined exclusion criteria will apply
研究组 & 干预措施
Placebo
Placebo Comparator
Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
干预措施: Placebo (Drug)
Nipocalimab
Experimental
Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
干预措施: Nipocalimab (Drug)
结局指标
主要结局
Stage B: Time to First Occurrence of a Relapse Event
时间窗: Up to 52 weeks
Stage B time to first occurrence of a relapse event will be reported.
次要结局
- Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)(12 weeks)
- Stage A: Percentage of Responders as Determined by ECI(12 weeks)
- Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score(Baseline to 12 weeks)
- Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score(Baseline to 12 weeks)
- Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score(Baseline to 12 weeks)
- Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)(Baseline to 12 weeks)
- Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)(Baseline to 12 weeks)
- Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline(Up to 52 weeks)
- Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline(Up to 52 weeks)
- Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score(Up to 52 weeks)
- Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score(Up to 52 weeks)
- Stage B: Change from Baseline Over Time in I-RODS Centile Score(Up to 52 weeks)
- Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)(Up to 52 weeks)
- Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)(Up to 52 weeks)
- Stage B: Number of Participants with Binary Response Endpoint Satisfying all 4 Conditions: a) An Improved Adjusted INCAT Disability Score Compared to Baseline; b) Not Relapsing; c) Not Switching to SoC; d) Not Discontinuing Treatment(Up to 52 weeks)
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Change in Electrocardiogram (ECG) Values Over Time(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Percentage of Participants with Serious Adverse Events (SAEs)(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Change in Vital Signs Values Over Time(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Clinically Significant ECG Abnormalities(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Change in Clinical Laboratory Values Over Time(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Clinically Significant Vital Signs Abnormalities(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Clinically Significant Clinical Laboratory Abnormalities(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Titers of ADA to Nipocalimab(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab(Stage A: 12 weeks; Stage B: Up to 52 weeks)
- Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time(Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks)
研究者
研究点 (199)
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