Clinical Trials List
Protocol NumberNVG-2089-201
Not yet recruiting
2024-10-10 - 2026-10-13
Phase II
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
Takeda Development Center Americas, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 林典佑 Division of Neurology
- 吳孟儒 Division of Neurology
- Chou-Ching Lin Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hong-Chou Kuo Division of Neurology
- 朱俊哲 Division of Neurology
- 廖洺鋒 Division of Neurology
- 劉采薇 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
Principal Investigator
Jia-Ying Sung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Objectives
To evaluate the safety and
tolerability of NVG-2089 in
participants with CIDP
Test Drug
injection
Active Ingredient
NVG-2089
Dosage Form
27D
Dosage
10 ml/vial
Endpoints
Incidence, nature, and severity of treatmentemergent adverse events (TEAEs), and serious
adverse events (SAEs)
• Clinically significant findings of laboratory, vital
signs, electrocardiogram, and physical
examinations
adverse events (SAEs)
• Clinically significant findings of laboratory, vital
signs, electrocardiogram, and physical
examinations
Inclution Criteria
Participants must meet all of the following criteria to be eligible for this trial:
• Age and Sex
1. Male or female who is at least 18 years of age at the time of signing the Participant's Consent Form (ICF).
• Diagnosis and Disease Characteristics
2. Diagnosed with CIDP or potential CIDP according to the 2021 European Association for Neurology and Peripheral Neurology (EAN/PNS) criteria. (The diagnosis must be confirmed by an independent decision-making committee).
3. The Adjusted Inflammatory Neuropathy Etiology and Treatment (INCAT) score must meet the following criteria:
a. Untreated participants: ≥ 2 points at screening
b. Treated participants: 2-7 points at screening
Note: The 2-point score should be entirely from the leg disability portion of the Adjusted INCAT. For participants with an Adjusted INCAT score ≥ 3 points at the time of entry into the trial (maximum 7 points for treated participants; no upper limit for untreated participants), there are no specific requirements for arm or leg scores. 4. Participants with prior treatment: Participants who received intravenous/subcutaneous immunoglobulin (IVIg/SCIg) at screening must provide documentation of the following within the 24 months prior to screening:
a. Clinically significant worsening following treatment interruption or reduction of standard of care (SOC) dose, as determined by clinical examination recorded in the medical record. A clinically significant worsening is defined as one of the following: an increase in adjusted INCAT score ≥ 1 point, a decrease in the total score of the Inflammatory Rasch Construction Overall Loss of Energy Scale (I-RODS) ≥ 4 points, a decrease in the total score of the Medical Research Council (MRC) index ≥ 3, a decrease in grip strength ≥ 8 kPa (either hand), or an equivalent worsening determined based on medical record information and the trial administrator's judgment.
Or
b. Improvement of CIDP symptoms following SOC treatment, based on medical record information and the trial administrator's judgment. 5. Treatment:
a. Treatment-naïve participants: Those who have not previously received IVIg and/or SCIg and/or corticosteroid treatment and/or CIDP investigational therapy.
Or
b. Treatment-previously treated participants: Those who have received a stable dose of IVIg or SCIg for 8 weeks prior to screening and have not experienced disease exacerbation. Participants must agree to discontinue IVIg or SCIg at least 3 weeks (±1 week) before administration of the investigational drug. Participants receiving IVIg treatment must receive a maintenance dose of 0.4 to 1 g/kg at intervals of 2 to 6 weeks, as recommended by EAN/PNS. Participants receiving SCIg treatment must not exceed a weekly dose of 0.4 g/kg.
• Fertility Considerations
Male or female contraceptive methods should comply with local regulations regarding contraceptive use by clinical trial participants.
6. Female participants of fertility must have negative serum pregnancy tests at screening and negative urine pregnancy tests on day 1.
7. Female participants having sexual intercourse with a male partner of fertility must use dual contraception (barrier method plus another method) for at least 28 days prior to screening and for 90 days after the last dose of the investigational drug; during this period, female participants must also avoid egg donation for reproductive purposes. Participants who have undergone sterilization or postmenopausal women (defined as those who have had natural menopause for 12 months or 6 months with a serum follicle-stimulating hormone concentration > 40 mIU/mL, or those who have undergone bilateral oophorectomy for more than 6 weeks, whether or not a hysterectomy was performed simultaneously) are exempt from the above requirements. Abstinence is acceptable if it is the participant's usual lifestyle and preferred method of contraception.
8. Male participants whose female partners are of fertility must agree to use highly effective barrier contraception during the trial and for 90 days after the last dose of the investigational drug. Subject Consent
9. The participant or their legal representative (LAR) is able to provide a signed subject consent form, including compliance with the requirements and limitations listed in the ICF.
• Age and Sex
1. Male or female who is at least 18 years of age at the time of signing the Participant's Consent Form (ICF).
• Diagnosis and Disease Characteristics
2. Diagnosed with CIDP or potential CIDP according to the 2021 European Association for Neurology and Peripheral Neurology (EAN/PNS) criteria. (The diagnosis must be confirmed by an independent decision-making committee).
3. The Adjusted Inflammatory Neuropathy Etiology and Treatment (INCAT) score must meet the following criteria:
a. Untreated participants: ≥ 2 points at screening
b. Treated participants: 2-7 points at screening
Note: The 2-point score should be entirely from the leg disability portion of the Adjusted INCAT. For participants with an Adjusted INCAT score ≥ 3 points at the time of entry into the trial (maximum 7 points for treated participants; no upper limit for untreated participants), there are no specific requirements for arm or leg scores. 4. Participants with prior treatment: Participants who received intravenous/subcutaneous immunoglobulin (IVIg/SCIg) at screening must provide documentation of the following within the 24 months prior to screening:
a. Clinically significant worsening following treatment interruption or reduction of standard of care (SOC) dose, as determined by clinical examination recorded in the medical record. A clinically significant worsening is defined as one of the following: an increase in adjusted INCAT score ≥ 1 point, a decrease in the total score of the Inflammatory Rasch Construction Overall Loss of Energy Scale (I-RODS) ≥ 4 points, a decrease in the total score of the Medical Research Council (MRC) index ≥ 3, a decrease in grip strength ≥ 8 kPa (either hand), or an equivalent worsening determined based on medical record information and the trial administrator's judgment.
Or
b. Improvement of CIDP symptoms following SOC treatment, based on medical record information and the trial administrator's judgment. 5. Treatment:
a. Treatment-naïve participants: Those who have not previously received IVIg and/or SCIg and/or corticosteroid treatment and/or CIDP investigational therapy.
Or
b. Treatment-previously treated participants: Those who have received a stable dose of IVIg or SCIg for 8 weeks prior to screening and have not experienced disease exacerbation. Participants must agree to discontinue IVIg or SCIg at least 3 weeks (±1 week) before administration of the investigational drug. Participants receiving IVIg treatment must receive a maintenance dose of 0.4 to 1 g/kg at intervals of 2 to 6 weeks, as recommended by EAN/PNS. Participants receiving SCIg treatment must not exceed a weekly dose of 0.4 g/kg.
• Fertility Considerations
Male or female contraceptive methods should comply with local regulations regarding contraceptive use by clinical trial participants.
6. Female participants of fertility must have negative serum pregnancy tests at screening and negative urine pregnancy tests on day 1.
7. Female participants having sexual intercourse with a male partner of fertility must use dual contraception (barrier method plus another method) for at least 28 days prior to screening and for 90 days after the last dose of the investigational drug; during this period, female participants must also avoid egg donation for reproductive purposes. Participants who have undergone sterilization or postmenopausal women (defined as those who have had natural menopause for 12 months or 6 months with a serum follicle-stimulating hormone concentration > 40 mIU/mL, or those who have undergone bilateral oophorectomy for more than 6 weeks, whether or not a hysterectomy was performed simultaneously) are exempt from the above requirements. Abstinence is acceptable if it is the participant's usual lifestyle and preferred method of contraception.
8. Male participants whose female partners are of fertility must agree to use highly effective barrier contraception during the trial and for 90 days after the last dose of the investigational drug. Subject Consent
9. The participant or their legal representative (LAR) is able to provide a signed subject consent form, including compliance with the requirements and limitations listed in the ICF.
Exclusion Criteria
Participants meeting any of the following exclusion criteria are ineligible to participate in this trial:
• Medical Condition
1. Pure sensory or distal CIDP variant (EAN/PNS definition).
2. History of unresponsiveness or loss of response to IVIg or SCIg, in the judgment of the trial administrator. Please note that participants who received IVIg treatment but relapsed after SCIg treatment will be allowed to participate in the trial.
3. Polyneuropathy of other causes, including: polymotor neuropathy; polyneuropathy caused by antimyelin-associated glycoprotein (MAG) antibodies; polyneuropathy caused by IgM monoclonal immunoglobulin hyperemia; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrine disorders, polysodium monoclonal and skin change syndrome (POEMS); lumbosacral nerve root plexus lesions; polyneuropathy probably caused by diabetes; polyneuropathy probably caused by systemic diseases; polyneuropathy caused by drugs or toxins.
4. Any other medical condition that could better explain the participant's signs and symptoms.
5. A history of any spinal cord lesions or evidence of central demyelinating disorders.
6. Any other known autoimmune disease that, as determined by the trial administrator, would interfere with the accurate assessment of CIDP clinical symptoms.
7. A history of severe mental illness (e.g., major depressive disorder, psychosis, bipolar disorder), suicide attempts, or current suicidal ideation, which, as determined by the trial administrator, may pose an undue risk to the patient or may affect adherence to the trial protocol.
8. Active liver disease, a history of ascites or hepatic encephalopathy, with total bilirubin > 2 mg/dL at screening (except for documented Gilbert's disease) or transaminase > 2 x ULN.
9. Abnormal hematological values at screening, including:
a. Hemoglobin < 10 g/dL for men, < 9 g/dL for women, or
b. Neutrophil count < 1.5 × 10⁹/L, or platelet count < 100 × 10⁹/L
10. Glycated hemoglobin (HbA1c) ≥ 7.5%
11. Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m² at screening.
12. History of malignancy, excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, breast carcinoma in situ, or incidentally discovered prostate cancer (TNM [tumor, lymph node, and metastasis classification] T1a or T1b stage).
The aforementioned malignant tumors must be adequately treated and show no signs of recurrence for at least 3 years prior to screening to be considered cured.
13. At the time of screening, heart failure (New York Heart Association III/IV), cardiomyopathy or unstable or advanced ischemic heart disease, clinically significant arrhythmias, and/or clinically significant electrocardiographic abnormalities are present.
14. At the time of screening, clinically significant active or chronic uncontrollable bacterial, viral, or fungal infections are present, including the following active viral infections:
− Active hepatitis B virus (HBV): Positive hepatitis B surface antigen (HBsAg);
− Active hepatitis C virus (HCV): Positive HCV-Ab serological test;
− Positive human immunodeficiency virus (HIV) serological test.
15. Active suicidal ideation, defined as a C-SSRS score of 4 (the most severe, indicating voluntary suicidal ideation with some intent but no specific plan) or 5 (indicating voluntary suicidal ideation with specific plan and intent), and the ideation appeared within one year prior to screening; or the participant answered "yes" to any of the five C-SSRS suicidal behaviors (suicide attempt, interrupted suicide attempt, abandoned suicide attempt, preparation behavior) and performed such an attempt or behavior within one year prior to screening; or, according to the trial administrator's judgment, the participant has a serious suicide risk.
16. Clinical evidence of other major serious illnesses, recent or planned major surgery, or any other cause that may confound the trial results or expose the participant to undue risk.
• Previous treatments
17. Exclusion of the following treatments:
a. Within one month prior to screening: prednisone or systemic corticosteroids.
b. Within 3 months prior to screening (or 5 half-lives of the drug, whichever is longer): plasma exchange or immunoadsorption, any Fc-containing therapeutic or other biologic agent, or any other investigational or approved drug.
c. Within 6 months prior to screening: rituximab, alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis factor alpha inhibitor, fingolimod, methotrexate, azathioprine, mycophenolate, any other immunomodulatory or immunosuppressive drug.
18. Participants who used or intentionally used prohibited drugs and therapies during the trial.
19. Participants who received an active attenuated vaccine within 28 days prior to screening. Received an inactive, subunit, polysaccharide, or conjugate vaccine at any time prior to screening is not an exclusion criterion.
• Previous/Concurrent Clinical Trial Experience
20. Previous participation in the NVG-2089 trial and at least one dose of the investigational drug.
• Other Exclusion Criteria
21. Known allergy to the investigational drug and/or any of its components.
22. Current or past (within the 12 months prior to screening) history of alcohol or drug abuse. A positive urine drug screening result at the follow-up screening visit.
23. Pregnant or breastfeeding women, and participants who intend to become pregnant during the trial or who do not wish to use an effective method of contraception (e.g., implants, injections, combined oral contraceptives, intrauterine devices [IUDs], abstinence, or whose partners have undergone vasectomy) for 90 days after the last administration of the investigational drug.
• Medical Condition
1. Pure sensory or distal CIDP variant (EAN/PNS definition).
2. History of unresponsiveness or loss of response to IVIg or SCIg, in the judgment of the trial administrator. Please note that participants who received IVIg treatment but relapsed after SCIg treatment will be allowed to participate in the trial.
3. Polyneuropathy of other causes, including: polymotor neuropathy; polyneuropathy caused by antimyelin-associated glycoprotein (MAG) antibodies; polyneuropathy caused by IgM monoclonal immunoglobulin hyperemia; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrine disorders, polysodium monoclonal and skin change syndrome (POEMS); lumbosacral nerve root plexus lesions; polyneuropathy probably caused by diabetes; polyneuropathy probably caused by systemic diseases; polyneuropathy caused by drugs or toxins.
4. Any other medical condition that could better explain the participant's signs and symptoms.
5. A history of any spinal cord lesions or evidence of central demyelinating disorders.
6. Any other known autoimmune disease that, as determined by the trial administrator, would interfere with the accurate assessment of CIDP clinical symptoms.
7. A history of severe mental illness (e.g., major depressive disorder, psychosis, bipolar disorder), suicide attempts, or current suicidal ideation, which, as determined by the trial administrator, may pose an undue risk to the patient or may affect adherence to the trial protocol.
8. Active liver disease, a history of ascites or hepatic encephalopathy, with total bilirubin > 2 mg/dL at screening (except for documented Gilbert's disease) or transaminase > 2 x ULN.
9. Abnormal hematological values at screening, including:
a. Hemoglobin < 10 g/dL for men, < 9 g/dL for women, or
b. Neutrophil count < 1.5 × 10⁹/L, or platelet count < 100 × 10⁹/L
10. Glycated hemoglobin (HbA1c) ≥ 7.5%
11. Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m² at screening.
12. History of malignancy, excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, breast carcinoma in situ, or incidentally discovered prostate cancer (TNM [tumor, lymph node, and metastasis classification] T1a or T1b stage).
The aforementioned malignant tumors must be adequately treated and show no signs of recurrence for at least 3 years prior to screening to be considered cured.
13. At the time of screening, heart failure (New York Heart Association III/IV), cardiomyopathy or unstable or advanced ischemic heart disease, clinically significant arrhythmias, and/or clinically significant electrocardiographic abnormalities are present.
14. At the time of screening, clinically significant active or chronic uncontrollable bacterial, viral, or fungal infections are present, including the following active viral infections:
− Active hepatitis B virus (HBV): Positive hepatitis B surface antigen (HBsAg);
− Active hepatitis C virus (HCV): Positive HCV-Ab serological test;
− Positive human immunodeficiency virus (HIV) serological test.
15. Active suicidal ideation, defined as a C-SSRS score of 4 (the most severe, indicating voluntary suicidal ideation with some intent but no specific plan) or 5 (indicating voluntary suicidal ideation with specific plan and intent), and the ideation appeared within one year prior to screening; or the participant answered "yes" to any of the five C-SSRS suicidal behaviors (suicide attempt, interrupted suicide attempt, abandoned suicide attempt, preparation behavior) and performed such an attempt or behavior within one year prior to screening; or, according to the trial administrator's judgment, the participant has a serious suicide risk.
16. Clinical evidence of other major serious illnesses, recent or planned major surgery, or any other cause that may confound the trial results or expose the participant to undue risk.
• Previous treatments
17. Exclusion of the following treatments:
a. Within one month prior to screening: prednisone or systemic corticosteroids.
b. Within 3 months prior to screening (or 5 half-lives of the drug, whichever is longer): plasma exchange or immunoadsorption, any Fc-containing therapeutic or other biologic agent, or any other investigational or approved drug.
c. Within 6 months prior to screening: rituximab, alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis factor alpha inhibitor, fingolimod, methotrexate, azathioprine, mycophenolate, any other immunomodulatory or immunosuppressive drug.
18. Participants who used or intentionally used prohibited drugs and therapies during the trial.
19. Participants who received an active attenuated vaccine within 28 days prior to screening. Received an inactive, subunit, polysaccharide, or conjugate vaccine at any time prior to screening is not an exclusion criterion.
• Previous/Concurrent Clinical Trial Experience
20. Previous participation in the NVG-2089 trial and at least one dose of the investigational drug.
• Other Exclusion Criteria
21. Known allergy to the investigational drug and/or any of its components.
22. Current or past (within the 12 months prior to screening) history of alcohol or drug abuse. A positive urine drug screening result at the follow-up screening visit.
23. Pregnant or breastfeeding women, and participants who intend to become pregnant during the trial or who do not wish to use an effective method of contraception (e.g., implants, injections, combined oral contraceptives, intrauterine devices [IUDs], abstinence, or whose partners have undergone vasectomy) for 90 days after the last administration of the investigational drug.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
60 participants
