Safety and Efficacy Study of VIS649 for IgA Nephropathy

Sponsor ID
VIS649-201
Clinicaltrials.gov ID
NCT04287985
EudraCT ID
2019-002531-29
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
VIS649-201
Trial Details
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Age
18+ years
Therapeutic Area
  • Autoimmune Disease
  • Glomerular Disease
  • IgAN
    • Sex
    Female & Male
    Trial Dates
    Jul 2020 - May 2023
    Healthy Volunteers
    No
    • Participants are eligible to be included in the study only if all of the following criteria apply:
    • Participant is a male or female ≥ 18 years of age at the time of signing the informed consent.
    • Participant must have biopsy-confirmed IgAN.
    • Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening. Participants should optimally be on at least 50% of the maximum recommended dose of these agents; however, if a participant is on their maximally tolerated dose (and this is \< 50% of the maximum recommended dose) and has been on this dose for at least 3 months, they may be enrolled. Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including BP control, is as per local SOC and applicable guidelines.
    • Participants must have screening uPCR ≥ 0.75 g/g measured from a 24-hour urine or 24-hour urine protein ≥ 1.0 g/d, as measured from 24-hour urine collection. The proteinuria should be assessed when the participant is considered to be in a steady state with no recent heavy exercise, fever, or other potential issues that could impact the result.
    • Participants must have eGFR ≥ 45 mL/min/1.73 m² using the CKD-EPI formula.
    • Participant's serum Ig values must meet specified criteria
    • Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
    • Participant is willing to adhere to contraceptive requirements.
    • Participant or a legally authorized representative is able and is willing to give voluntary written informed consent
    • Participants are excluded from the study if they meet any of the following criteria:
    • Participant has secondary forms of IgAN as defined by the treating physician.
    • Participant has co-existing CKD, other than IgAN.
    • Participant has evidence of additional pathological findings in the kidney biopsy (eg, diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable.
    • Participant has kidney biopsy MEST or MEST-C score as defined in the protocol.
    • Participant has nephrotic syndrome.
    • Participant has received a solid organ transplant, including kidney.
    • Participant has received bone marrow or hematologic stem cell transplantation.
    • Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids).
    • Participant has received treatment with systemic corticosteroid therapy within 16 weeks of initial screening.
    • Participant has received treatment with a systemic immunosuppressive agents within 16 weeks of initial screening.
    • Participant has any chronic infectious disease.
    • Participant has acute infectious disease at the time of screening.
    • Participant has Type 1 diabetes.
    • Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value \> 8%.
    • Participant has uncontrolled BP (\> 140 mm Hg systolic or \> 90 mm Hg diastolic)
    • Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
    • Participant has a known allergy or intolerance to any component of the study intervention.
    • Participant is breastfeeding.
    • Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator.
    • Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year.
    • Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count \< 100,000/μL or alanine aminotransferase \> 3× upper limit of normal.
    • Participant has active malignancy or is receiving chemotherapy for malignancy, except for nonmelanoma skin cancers and cervical carcinoma in situ. Participants with prior malignancy who have been documented to be cancer-free for ≥ 5 years may be enrolled.
    • Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening).
    • Participant enrolled in another investigational drug or device study within 3 months prior to initial screening.
    • Participant with a pre-existing illness other than those listed above that, in the opinion of the Investigator, would place the participant at increased risk through participation in this study.
    • Participant is unable to comply with study protocol procedures and/or study visit schedules.
    • Participant with known or suspected alcohol or drug abuse that would compromise their safety or study participation of the participant, in the opinion of the Investigator.

    Study Summary

    The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: Dose-Placebo
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    155
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Participants are eligible to be included in the study only if all of the following criteria apply:
    • 1. Participant is a male or female ≥ 18 years of age at the time of signing the informed consent.

    Exclusion Criteria

    • Participants are excluded from the study if they meet any of the following criteria:
    • 1. Participant has secondary forms of IgAN as defined by the treating physician.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Participants are eligible to be included in the study only if all of the following criteria apply:
    • Participant is a male or female ≥ 18 years of age at the time of signing the informed consent.
    • Participant must have biopsy-confirmed IgAN.
    • Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening. Participants should optimally be on at least 50% of the maximum recommended dose of these agents; however, if a participant is on their maximally tolerated dose (and this is \< 50% of the maximum recommended dose) and has been on this dose for at least 3 months, they may be enrolled. Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including BP control, is as per local SOC and applicable guidelines.
    • Participants must have screening uPCR ≥ 0.75 g/g measured from a 24-hour urine or 24-hour urine protein ≥ 1.0 g/d, as measured from 24-hour urine collection. The proteinuria should be assessed when the participant is considered to be in a steady state with no recent heavy exercise, fever, or other potential issues that could impact the result.
    • Participants must have eGFR ≥ 45 mL/min/1.73 m² using the CKD-EPI formula.
    • Participant's serum Ig values must meet specified criteria
    • Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
    • Participant is willing to adhere to contraceptive requirements.
    • Participant or a legally authorized representative is able and is willing to give voluntary written informed consent
    Exclusion Criteria:
    • Participants are excluded from the study if they meet any of the following criteria:
    • Participant has secondary forms of IgAN as defined by the treating physician.
    • Participant has co-existing CKD, other than IgAN.
    • Participant has evidence of additional pathological findings in the kidney biopsy (eg, diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable.
    • Participant has kidney biopsy MEST or MEST-C score as defined in the protocol.
    • Participant has nephrotic syndrome.
    • Participant has received a solid organ transplant, including kidney.
    • Participant has received bone marrow or hematologic stem cell transplantation.
    • Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids).
    • Participant has received treatment with systemic corticosteroid therapy within 16 weeks of initial screening.
    • Participant has received treatment with a systemic immunosuppressive agents within 16 weeks of initial screening.
    • Participant has any chronic infectious disease.
    • Participant has acute infectious disease at the time of screening.
    • Participant has Type 1 diabetes.
    • Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value \> 8%.
    • Participant has uncontrolled BP (\> 140 mm Hg systolic or \> 90 mm Hg diastolic)
    • Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
    • Participant has a known allergy or intolerance to any component of the study intervention.
    • Participant is breastfeeding.
    • Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator.
    • Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year.
    • Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count \< 100,000/μL or alanine aminotransferase \> 3× upper limit of normal.
    • Participant has active malignancy or is receiving chemotherapy for malignancy, except for nonmelanoma skin cancers and cervical carcinoma in situ. Participants with prior malignancy who have been documented to be cancer-free for ≥ 5 years may be enrolled.
    • Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening).
    • Participant enrolled in another investigational drug or device study within 3 months prior to initial screening.
    • Participant with a pre-existing illness other than those listed above that, in the opinion of the Investigator, would place the participant at increased risk through participation in this study.
    • Participant is unable to comply with study protocol procedures and/or study visit schedules.
    • Participant with known or suspected alcohol or drug abuse that would compromise their safety or study participation of the participant, in the opinion of the Investigator.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    Visterra Investigational Site
    Birmingham, Alabama, United States, 35294
    Status
    N/A
    Location
    Visterra Investigational Site
    Los Angeles, California, United States, 90027
    Status
    N/A
    Location
    Visterra Investigational Site
    Oxnard, California, United States, 93036
    Status
    N/A
    Location
    Visterra Investigational Site
    Palo Alto, California, United States, 94305
    Status
    N/A
    Location
    Visterra Investigational Site
    Stanford, California, United States, 94305
    Status
    N/A
    Location
    Visterra Investigational Site
    Denver, Colorado, United States, 80230
    Status
    N/A
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    January 2026 01US25EUC0489

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