2024-515386-34-00招募中2 期
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Nuvig Therapeutics Inc.18 个研究点 分布在 6 个国家目标入组 99 人开始时间: 2025年4月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 18
- 主要终点
- Incidence, nature, and severity of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
研究概览
简要总结
To evaluate the safety and tolerability of NVG-2089 in participants with CIDP
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females at least 18 years of age at the time of signing the ICF.
- •Diagnosed with CIDP or Possible CIDP according to criteria of the EAN/PNS
- •Must have an adjusted INCAT score as follows: a. Treatment-naïve participants: ≥2 at screening b. Treatment-experienced participants: 2-7 at screening Note: A score of 2 should be exclusively from leg disability component of adjusted INCAT. For participants with an adjusted INCAT score of ≥3 (and up to 7 for treatment-experienced; no upper limit for treatment-naïve) at study entry, there are no specific requirements for arm or leg scores.
- •Treatment-experienced participants: Participants who were treated with IVIg/SCIg at the time of screening must have documented evidence within 24 months of screening of: a. Clinically meaningful deterioration on treatment interruption or dose reduction of standard of care (SOC) therapy, determined by clinical examination documented in the medical records. Clinically meaningful deterioration is defined as one of the following: ≥1-point increase in adjusted INCAT score, decrease in I-RODS total score ≥4 points, decrease in MRC Sum score ≥3, grip strength worsening of ≥8 kPa (in either hand), or an equivalent deterioration based on information from medical records and at the investigator’s judgement. OR b. Improvement in CIDP symptoms with SOC therapy based on information in medical records and at the investigator’s judgement. In assessing the history of response to IVIg/SCIg, the investigator should account for prior treatment (type, dose regimen, duration), pattern of response or non-response to treatment.
- •Treatments: a. Treatment-naïve participants: No prior treatment with IVIg and/or SCIg and/or corticosteroids and/or investigational therapies for CIDP. OR b. Treatment-experienced participants: On stable dose of IVIg or SCIg with no disease exacerbations for 8 weeks prior to screening. Participants must be willing to discontinue IVIg or SCIg at least 3 weeks (±1 week) prior to dosing with the study drug. Participants on IVIg must be on maintenance dose of 0.4 to 1 g/kg every 2 to 6 weeks per EAN/PNS recommendation. Participants on SCIg should not exceed the dose of 0.4 g/kg per week.
- •Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day
- •Female participants who are sexually active with a male partner of reproductive potential must use double contraception (including a barrier contraceptive and another method) from at least 28 days prior to Screening and for 90 days after last dose of study drug; female participants must also refrain from oocyte donation for the purpose of reproduction during this period. Exceptions are made for surgically sterile participants, or post-menopausal females (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy). Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- •Male participants with female partners who are of reproductive potential must agree to the use of highly effective, barrier contraception for the duration of the study, and for 90 days after the last dose of study drug.
- •Participant is capable or has (a) legally authorized representative(s) (LAR[s]) capable of providin a signed informed consent which includes compliance with the requirements and restrictions listed in the ICF .
排除标准
- •Pure sensory or distal CIDP variants (EAN/PNS definition).
- •Participants who (intend to) use prohibited medications and therapies during the study.
- •Have received a live-attenuated vaccine within 28 days before screening. An inactivated, sub-unit, polysaccharide, or conjugate vaccine any time before screening is not exclusionary.
- •History of being non-responder or loss of response to IVIg or SCIg per Investigator’s determination. In assessing the history of response or loss of response to IVIg/SCIg, the investigator should account for prior treatment (type, dose regimen, duration), pattern of response or non-response to treatment. Note, participants who are on IVIg but relapsed on SCIg will be allowed to enter the study.
- •Previously participated in a study with NVG-2089 and have received at least one administration of study drug.
- •A known allergy to study drug and/or any of its components.
- •Current or past history (within 12 months of screening) of alcohol, drug, or medication abuse. Positive urine drug screen at screening visit.
- •Pregnant and lactating women and those intending to become pregnant during the study or are unwilling to apply an effective birth control method (such as implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence, or vasectomized partner) up to 90 days after last study drug administration.
- •Polyneuropathy of other causes, including the following: multifocal motor neuropathy; polyneuropathy associated with anti-myelin associated glycoprotein (MAG) antibodies, polyneuropathy associated with IgM monoclonal gammopathy; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (POEMS); lumbosacral radiculoplexus neuropathy; polyneuropathy most likely due to diabetes mellitus; polyneuropathy most likely due to systemic illnesses; drug- or toxin-induced polyneuropathy.
- •Any other disease that could better explain the participant's signs and symptoms.
- •Any history of myelopathy or evidence of central demyelination.
- •Glycated hemoglobin (HbA1c) ≥7.5%
- •Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of CIDP.
- •Severe psychiatric disorder (such as severe depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the patient or could affect adherence with the study protocol.
- •Active liver disease, with history of ascites or hepatic encephalopathy, total bilirubin > 2 mg/dL (except in the case of documented Gilbert’s disease), or transaminases > 2 X ULN at screening.
- •Hematology abnormalities at screening including: a. hemoglobin < 10 g/dL in males and <9 g/dL in females, or b. neutrophils < 1.5 × 10^9/L, or platelets <100 × 10^9/L"
- •Acute demyelinating neuropathies including Gullian-Barre syndrome
- •Chronic kidney disease as defined by estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m^2 at screening.
- •History of malignancy except adequately treated basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, or Incidental histological finding of Prostate cancer (TNM [tumor, nodes, and metastases classification] stage T1a or T1b). The above malignancies must be deemed cured by adequate treatment with no evidence of recurrence for at least 3 years prior to screening.
- •Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, or unstable or advanced ischemic heart disease, clinically significant cardiac dysrhythmia and/or clinically significant ECG findings at screening.
- •Clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening, including active viral infection at screening with: - Active Hepatitis B Virus (HBV): Hepatitis surface antigen (HBsAg) positive; - Active Hepatitis C Virus (HCV): serology positive for HCV-Ab; - Human Immunodeficiency Virus (HIV) positive serology."
- •Active suicidal ideation as measured by a most severe suicide ideation score of 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS if the ideation occurred within 1 year of Screening, or participants who answered “Yes” on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior), if the attempt or acts were performed within 1 year of Screening, or participants who, in the opinion of the Investigator, present a serious risk of suicide
- •Clinical evidence of other significant serious disease, recent or planned major surgery, or any other reason which could confound the results of the study or put the participant at undue risk.
- •The following therapies are excluded: a. Within 1 month before screening: Prednisone or systemic corticosteroids b. Within 3 months (or 5 half-lives of the drug, whichever is longer) before screening: plasma exchange or immunoadsorption, any Fc-containing therapeutic agents or other biological, or any other investigational or approved product. c. Within 6 months before screening: rituximab, alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, methotrexate, azathioprine, mycophenolate, any other immunomodulating or immunosuppressive medications.
结局指标
主要结局
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
Clinically significant findings of laboratory, vital signs, electrocardiogram, and physical examinations
Clinically significant findings of laboratory, vital signs, electrocardiogram, and physical examinations
次要结局
- Treatment-naïve Participants: Percentage of participants with evidence of clinical improvement (ECI) at Week 14. ECI is defined as improvement of 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (adjusted INCAT) score, or 4 points on Inflammatory Rasch-built Overall Disability Scale (I-RODS) or 8 kilopascal (kPa) on mean grip strength (dominant hand).
- Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - Achieving ECI at Week 14 - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14
- Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14
- Treatment-experienced Participants: Percentage of participants with ECI at Week 14
- Change from baseline over time in: - Adjusted INCAT score - Medical Research Council (MRC) sum score - I-RODS disability scores - Mean grip strength
- The PK parameters of NVG-2089 concentrations in plasma
- Incidence and characteristics of ADA after dosing
- PK concentrations and safety profile in participants with ADA
研究者
Alan Glicklich
Scientific
Nuvig Therapeutics Inc.
研究点 (18)
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