Safety and Efficacy Study of VIS649 for IgA Nephropathy
NCT ID: NCT04287985
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2020-07-20
2023-06-18
Brief Summary
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Detailed Description
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The study is comprised of three main periods, Screening, Treatment (12 months) and Follow-Up (4 months). Approximately 144 patients will be enrolled. The findings from this study will form the basis for subsequent clinical development of VIS649.
VIS649 is a humanized immunoglobulin G (IgG2) monoclonal antibody that binds to and blocks the biological actions of the cytokine A PRoliferation Inducing Ligand (APRIL), a key factor in the production of aberrantly glycosylated IgA1 (a-g- IgA1), which is critical to the pathogenesis of IgAN.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo, normal saline (0.9% NaCl) will be administered IV
Dose-Placebo
Unit Dose Strength - 0.9%.
Low Dose - VIS649
Low dose of VIS649 administered IV
Low Dose-VIS649
Dose Level = Low
Medium Dose - VIS649
Medium dose of VIS649 administered IV
Medium Dose-VIS649
Dose Level = Medium
High Dose - VIS649
High dose of VIS649 administered IV
High Dose-VIS649
Dose Level = High
Interventions
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Dose-Placebo
Unit Dose Strength - 0.9%.
Low Dose-VIS649
Dose Level = Low
Medium Dose-VIS649
Dose Level = Medium
High Dose-VIS649
Dose Level = High
Eligibility Criteria
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Inclusion Criteria
1. Participant is a male or female ≥ 18 years of age at the time of signing the informed consent.
2. Participant must have biopsy-confirmed IgAN.
3. 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.
4. 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.
5. Participants must have eGFR ≥ 45 mL/min/1.73 m² using the CKD-EPI formula.
6. Participant's serum Ig values must meet specified criteria
7. Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
8. Participant is willing to adhere to contraceptive requirements.
9. Participant or a legally authorized representative is able and is willing to give voluntary written informed consent
Exclusion Criteria
1. Participant has secondary forms of IgAN as defined by the treating physician.
2. Participant has co-existing CKD, other than IgAN.
3. 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.
4. Participant has kidney biopsy MEST or MEST-C score as defined in the protocol.
5. Participant has nephrotic syndrome.
6. Participant has received a solid organ transplant, including kidney.
7. Participant has received bone marrow or hematologic stem cell transplantation.
8. Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids).
9. Participant has received treatment with systemic corticosteroid therapy within 16 weeks of initial screening.
10. Participant has received treatment with a systemic immunosuppressive agents within 16 weeks of initial screening.
11. Participant has any chronic infectious disease.
12. Participant has acute infectious disease at the time of screening.
13. Participant has Type 1 diabetes.
14. Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value \> 8%.
15. Participant has uncontrolled BP (\> 140 mm Hg systolic or \> 90 mm Hg diastolic)
16. Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
17. Participant has a known allergy or intolerance to any component of the study intervention.
18. Participant is breastfeeding.
19. Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator.
20. Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year.
21. 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.
22. 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.
23. Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening).
24. Participant enrolled in another investigational drug or device study within 3 months prior to initial screening.
25. 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.
26. Participant is unable to comply with study protocol procedures and/or study visit schedules.
27. 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.
18 Years
ALL
No
Sponsors
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Visterra, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Asher Schachter, M.D.
Role: STUDY_DIRECTOR
Visterra, Inc.
Locations
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Visterra Investigational Site
Birmingham, Alabama, United States
Visterra Investigational Site
Los Angeles, California, United States
Visterra Investigational Site
Oxnard, California, United States
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Palo Alto, California, United States
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Stanford, California, United States
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Denver, Colorado, United States
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Lawrenceville, Georgia, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Tupelo, Mississippi, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Columbus, Ohio, United States
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Bethlehem, Pennsylvania, United States
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Houston, Texas, United States
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Houston, Texas, United States
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New Lambton Heights, New South Wales, Australia
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Saint Leonards, New South Wales, Australia
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Nambour, Queensland, Australia
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Nedlands, Western Australia, Australia
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Calgary, Alberta, Canada
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Brampton, Ontario, Canada
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Montreal, Quebec, Canada
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Hong Kong, HK, Hong Kong
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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Tsuen Wan, , Hong Kong
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Chandigarh, Chandigarh, India
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Bangalore, Karnataka, India
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Bengaluru, Karnataka, India
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Manipal, Karnataka, India
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Kozhikode, Kerala, India
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Thiruvananthapuram, Kerala, India
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New Delhi, National Capital Territory of Delhi, India
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Vellore, Tamil Nadu, India
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Hyderabad, Telangana, India
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Hyderabad, Telangana, India
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Raebareli, Uttar Pradesh, India
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Toyoake-shi, Aichi-ken, Japan
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Tokyo, Nerima Ku, Japan
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Ashikaga, Tochigi, Japan
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Ashikaga-Shi, , Japan
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Bunkyō City, , Japan
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Kashihara-shi, , Japan
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Minatoku, , Japan
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Niigata, , Japan
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Shinjuku-Ku, , Japan
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Tsukuba, , Japan
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Urayasu-Shi, , Japan
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Klang, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuantan, , Malaysia
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Seremban, , Malaysia
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Diliman, , Philippines
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Quezon City, , Philippines
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Singapore, , Singapore
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Singapore, , Singapore
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Seoul, Dongdaemun-gu, South Korea
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Anyang-si, Gyeonggi-do, South Korea
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Anyang, , South Korea
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Gangdong, , South Korea
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Hwaseong-si, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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L'Hospitalet de Llobregat, B, Spain
Visterra Investigational Site
Santander, CB, Spain
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Córdoba, CO, Spain
Visterra Investigational Site
Seville, SE, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Seville, , Spain
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Valencia, , Spain
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Colombo, , Sri Lanka
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Kandy, , Sri Lanka
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Nugegoda, , Sri Lanka
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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New Taipei City, , Taiwan
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New Taipei City, , Taiwan
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Xitun, , Taiwan
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Bangkok, , Thailand
Visterra Investigational Site
Chiang Mai, , Thailand
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Ratchathewi, , Thailand
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Bradford, , United Kingdom
Visterra Investigational Site
London, , United Kingdom
Visterra Investigational Site
London, , United Kingdom
Visterra Investigational Site
London, , United Kingdom
Visterra Investigational Site
Salford, , United Kingdom
Countries
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References
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Mathur M, Barratt J, Chacko B, Chan TM, Kooienga L, Oh KH, Sahay M, Suzuki Y, Wong MG, Yarbrough J, Xia J, Pereira BJG; ENVISION Trial Investigators Group. A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy. N Engl J Med. 2024 Jan 4;390(1):20-31. doi: 10.1056/NEJMoa2305635. Epub 2023 Nov 2.
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Provided Documents
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Document Type: Study Protocol: Version 4
Document Type: Study Protocol: Version 3
Document Type: Study Protocol: Version 2
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002531-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1263-1268
Identifier Type: OTHER
Identifier Source: secondary_id
VIS649-201
Identifier Type: -
Identifier Source: org_study_id
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