Clinical Trials List
Protocol NumberNVG-2089-201
NCT Number(ClinicalTrials.gov Identfier)NCT07027111
Not yet recruiting
2024-10-10 - 2026-10-13
Recruiting4
ICD-10G61.81
Chronic inflammatory demyelinating polyneuritis
ICD-10G61.89
Other inflammatory polyneuropathies
ICD-10G62.81
Critical illness polyneuropathy
ICD-10G62.89
Other specified polyneuropathies
ICD-10G64
Other disorders of peripheral nervous system
ICD-9357.8
Other inflammatory and toxic neuropathy
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)
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/22
Investigators and Locations
Co-Principal Investigator
- 廖洺鋒 Division of Neurology
- 劉采薇 Division of Neurology
- Hong-Chou Kuo Division of Neurology
- 朱俊哲 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蔡宛蓁 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Shan Huang Division of Neurology
- 黃怡臻 Division of Neurology
- Yi-Chen Lin Division of Neurology
- 李靜娥 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Han-Wei Huang
Co-Principal Investigator
- 林典佑 Division of Neurology
- Chou-Ching Lin Division of Neurology
- 吳孟儒 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Inflammatory Demyelinating Polyneuropathy
Objectives
Primary Objective: To evaluate the safety and tolerability of NVG-2089 in patients with CIDP.
Key Secondary Objective: To evaluate the efficacy of NVG-2089 in patients with CIDP.
Secondary Objectives:
Further evaluate the efficacy of NVG-2089 in patients with CIDP.
Investigate the PK characteristics of NVG-2089 in patients with CIDP.
Assess the immunogenicity of NVG-2089 and the impact of the presence of anti-drug antibodies (ADA) on plasma PK concentrations and clinical safety.
Test Drug
注射液劑
Active Ingredient
NVG-2089
Dosage Form
27D
Dosage
10 ml/vial
Endpoints
• Incidence, nature, and severity of treatment-associated adverse events (TEAEs) and serious adverse events (SAEs) occurring during treatment.
• Clinically significant findings in laboratory tests, vital signs, electrocardiograms, and physical examinations.
• Clinically significant findings in laboratory tests, vital signs, electrocardiograms, and physical examinations.
Inclution Criteria
Inclusion Criteria:
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 2021 (Van den Bergh, 2021). (Diagnosis is to be confirmed by an independent adjudication committee; refer to Section 8.1.1).
Must have an adjusted INCAT score as follows:
Treatment-naïve participants: ≥2 at screening
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:
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
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.
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.
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 2021 (Van den Bergh, 2021). (Diagnosis is to be confirmed by an independent adjudication committee; refer to Section 8.1.1).
Must have an adjusted INCAT score as follows:
Treatment-naïve participants: ≥2 at screening
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:
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
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.
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.
Exclusion Criteria
Exclusion Criteria:
Pure sensory or distal CIDP variants (EAN/PNS definition)
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.
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.
Acute demyelinating neuropathies including Guillain-Barre syndrome.
Any other disease that could better explain the participant's signs and symptoms.
Any history of myelopathy or evidence of central demyelination.
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.
Pure sensory or distal CIDP variants (EAN/PNS definition)
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.
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.
Acute demyelinating neuropathies including Guillain-Barre syndrome.
Any other disease that could better explain the participant's signs and symptoms.
Any history of myelopathy or evidence of central demyelination.
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.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
60 participants
