NCT06858579招募中3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 192
- 主要终点
- Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)
研究概览
简要总结
The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
详细描述
The study includes the following periods:
- Part A: An open-label period (up to 13 weeks)
- Part B: A randomized, placebo-controlled, double-blind treatment period (up to 52 weeks) for participants who respond to DNTH103 in Part A
- Optional open-label extension (OLE) for eligible participants (up to 104 weeks)
- Safety follow-up (40 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have given written informed consent before any study-related activities are carried out.
- •Weight range between 40 kilograms (kg) and 120 kg.
- •Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.
- •CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
- •Must be neurologically stable.
- •Must have an INCAT score between 2 and 9 inclusive.
- •Must fulfill one of the following treatment conditions for CIDP:
- •Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin [IVIg] or subcutaneous immunoglobulin [SCIg]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.
- •Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.
- •Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and/or oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.
- •Treatment naïve with no history of prior treatment for CIDP.
- •Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
- •Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
- •Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.
排除标准
- •Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
- •Known evidence of central demyelination or known history of myelopathy.
- •History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety/efficacy or study procedures.
- •Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
- •Known complement deficiency or history of positive titer for anti-C1 antibodies.
- •Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).
- •Participants with an autoimmune disease affecting joints, muscle or nervous system.
- •Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.
- •Prior history of N. meningitidis infection.
- •History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.
- •Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
研究组 & 干预措施
Placebo (Part B)
Placebo Comparator
Placebo SC once every 2 weeks for up to 52 weeks.
干预措施: Placebo (Drug)
Claseprubart (Part B)
Experimental
Claseprubart SC once every 2 weeks for up to 52 weeks.
干预措施: Claseprubart (Drug)
Claseprubart (Part A)
Experimental
Claseprubart intravenous (IV) loading dose on Day 1.
Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks.
干预措施: Claseprubart (Drug)
Claseprubart (Optional OLE)
Experimental
Claseprubart SC once every 2 weeks for up to 104 weeks.
干预措施: Claseprubart (Drug)
结局指标
主要结局
Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)
时间窗: Part B baseline to Part B end of treatment period (up to Week 52)
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
次要结局
- Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand(Part B baseline to Part B end of treatment period (up to Week 52))
- Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score(Part B baseline to Part B end of treatment period (up to Week 52))
- Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT(Part B baseline to end of treatment period for Part B (up to Week 52))
- Parts A and B: Change in Adjusted INCAT Score(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B: Change in Grip Strength in the Nondominant Hand(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B: Change in Medical Research Council Sum Score (MRC-SS)(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Part A: Percentage of Participants with a Confirmed Response to DNTH103 as Assessed by the Adjusted INCAT(Part A baseline to Part A end of treatment period (up to Week 13))
- Parts A and B and OLE: Change in Adjusted INCAT Score(Part A baseline to OLE Week 52 and Week 104; Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104)
- Part B and OLE: Percentage of Participants With a Confirmed Relapse as Assessed by the Adjusted INCAT(Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104)
- Parts A, B, OLE, and Safety Follow-up: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)(Part A baseline through Safety Follow-up period (up to approximately 209 weeks))
- Parts A, B, OLE, and Safety Follow-up: Serum Concentrations of DNTH103(Part A baseline through Safety Follow-up period (up to approximately 209 weeks))
- Parts A, B, and OLE: Change from Baseline in Complement Total Blood Test (CH50)(Part A baseline through Safety Follow-up period (up to approximately 209 weeks))
- Parts A and B: Change in I-RODS Score (Centile Metric)(Part A baseline up to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score(Part B baseline to Part B end of treatment period (up to Week 52))
- Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand(Part B baseline to Part B end of treatment period (up to Week 52))
- Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT(Part B baseline to end of treatment period for Part B (up to Week 52))
- Parts A and B: Change in I-RODS Score(Part A baseline up to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B: Change in Grip Strength in the Dominant Hand(Part A baseline to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B: Change in Adjusted INCAT Score(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B: Change in Grip Strength in the Nondominant Hand(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B: Change in Medical Research Council Sum Score (MRC-SS)(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Part A: Percentage of Participants with a Confirmed Response to DNTH103 as Assessed by the Adjusted INCAT(Part A baseline to Part A end of treatment period (up to Week 13))
- Parts A and B: Change in Euro-Quality of Life Visual Analogue Scale (EQ-VAS)(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B: Change in Fatigue Severity Scale (FSS)(Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52))
- Parts A and B and OLE: Change in Adjusted INCAT Score(Part A baseline to OLE Week 52 and Week 104; Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104)
- Part B and OLE: Percentage of Participants With a Confirmed Relapse as Assessed by the Adjusted INCAT(Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104)
- Parts A, B, OLE, and Safety Follow-up: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)(Part A baseline through Safety Follow-up period (up to approximately 209 weeks))
- Parts A, B, OLE, and Safety Follow-up: Serum Concentrations of DNTH103(Part A baseline through Safety Follow-up period (up to approximately 209 weeks))
- Parts A, B, and OLE: Change from Baseline in Complement Total Blood Test (CH50)(Part A baseline through Safety Follow-up period (up to approximately 209 weeks))
- Parts A, B, OLE, and Safety Follow-up: Incidence and Titer of Antidrug Antibodies (ADAs)(Part A baseline through Safety Follow-up period (up to approximately 209 weeks))
研究者
研究点 (192)
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