Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN

Study Overview

• Status: Enrolling by invitation
• Conditions: Immunoglobulin A Nephropathy
• Intervention / Treatment: Drug: Sibeprenlimab 400 mg s.c. Q4weeks

Detailed Description

This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.

Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Clinical Research Site #800
  • Buenos Aires, Argentina, C1425
    • Clinical Research Site #802
  • Córdoba, Argentina, X5016LIG
    • Clinical Research Site #801
• Australia
  • Liverpool, Australia, 2170
    • Clinical Research Site #011
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Clinical Research Site #003
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Clinical Research Site #013
    • Kogarah, New South Wales, Australia, 2217
      • Clinical Research Site #014
    • New Lambton Heights, New South Wales, Australia, 2305
      • Clinical Research Site
    • Saint Leonards, New South Wales, Australia, 2065
      • Clinical Research Site #006
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Clinical Research Site #012
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Clinical Research Site #001
    • St Albans, Victoria, Australia, 3021
      • Clinical Research Site #010
• Belgium
  • Genk, Belgium, 3600
    • Clinical Research Site #401
  • Genk, Belgium, 3600
    • Clinical Research Site #405
• Brazil
  • Rio de Janeiro, Brazil, 20550-010
    • Clinical Research Site #831
  • São Paulo, Brazil, 01246-903
    • Clinical Research Site #823
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-901
      • Clinical Research Site #820
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Clinical Research Site #824
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89227-680
      • Clinical Research Site #821
  • So Paulo
    • São José do Rio Preto, So Paulo, Brazil, 15090-000
      • Clinical Research Site #822
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2R 0X7
      • Clinical Research Site #300
  • Ontario
    • Scarborough Village, Ontario, Canada, M1H 3G4
      • Clinical Research Site #305
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Clinical Research Site #036
    • Beijing, Beijing Municipality, China, 100034
      • Clinical Research Site #020
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Clinical Research Site #028
  • Hunan
    • Changsha, Hunan, China, 410011
      • Clinical Research Site #044
  • Jiangsu
    • Wuxi, Jiangsu, China, 214023
      • Clinical Research Site #030
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Clinical Research Site #022
  • Shandong
    • Jinan, Shandong, China, 250013
      • Clinical Research Site #026
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Clinical Research Site #038
    • Yibin, Sichuan, China, 644002
      • Clinical Research Site #025
• Croatia
  • Split, Croatia, 21000
    • Clinical Research Site #413
  • Zagreb, Croatia, 10000
    • Clinical Research Site #414
• Czechia
  • Prague, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
• France
  • Auvergne-Rhône-Alpes
    • Grenoble, Auvergne-Rhône-Alpes, France, 38043
      • Clinical Research Site #433
  • Gard
    • Nîmes, Gard, France, 30900
      • Clinical Research Site #430
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Clinical Research Site #432
  • New Aquitaine
    • Limoges, New Aquitaine, France, 87000
      • Clinical Research Site #439
  • Pays de la Loire Region
    • Sr Priest En Jarez, Pays de la Loire Region, France, 42270
      • Clinical Research Site #434
• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Clinical Research Site #455
  • Saxony
    • Dresden, Saxony, Germany, 1307
      • Universitaetsklinikum Carl Gustav Carus
• Greece
  • Heraklion, Greece, 71110
    • Clinical Research Site #472
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Clinical Research Site #060
  • Hong Kong, Hong Kong, 999077
    • Clinical Research Site #061
  • Kowloon, Hong Kong, 999077
    • Clinical Research Site #062
  • Shatin, Hong Kong, 999077
    • Clinical Research Site #063
  • New Territories
    • Hong Kong, New Territories, Hong Kong
      • Clinical Research Site #064
• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • Clinical Research Site #482
• India
  • Deccan
    • Hyderabad, Deccan, India, 500082
      • Clinical Research Site #081
  • Gujarat
    • Ahmedabad, Gujarat, India, 382421
      • Clinical Research Site #073
    • Nadiād, Gujarat, India, 387001
      • Clinical Research Site #070
  • Karnataka
    • Bengaluru, Karnataka, India, 560099
      • Clinical Research Site #087
    • Manipal, Karnataka, India, 576104
      • Clinical Research Site #079
  • Kerala
    • Kozhikode, Kerala, India, 673008
      • Clinical Research Site #071
    • Thiruvananthapuram, Kerala, India, 695011
      • Clinical Research Site #074
  • Maharashtra
    • Pune, Maharashtra, India, 411057
      • Clinical Research Site #084
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 1100060
      • Clinical Research Site #075
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • Clinical Research Site #077
  • Tamil Nadu
    • Rajipet, Tamil Nadu, India, 632517
      • Clinical Research Site #080
  • Telangana
    • Afzalganj, Telangana, India, 500012
      • Clinical Research Site #078
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226014
      • Clinical Research Site #076
• Israel
  • Ashkelon, Israel, 7830604
    • Clinical Research Site #494
  • Kfar Saba, Israel, 44281
    • Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital)
  • Nahariya, Israel, 22100
    • Clinical Research Site #495
  • Petach Tiqwa, Israel, 49100
    • Clinical Research Site #493
• Italy
  • Bologna, Italy, 40138
    • Clinical Research Site #512
  • Genova, Italy, 16132
    • Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino
  • Pavia, Italy, 27100
    • Clinical Research Site #509
  • Piacenza, Italy, 29121
    • Clinical Research Site #507
• Japan
  • Fukuoka, Japan, 812-8582
    • Clinical Research Site #703
  • Minatoku, Japan, 105-8471
    • Clinical Research Site #712
  • Miyazaki, Japan, 889-1692
    • Clinical Research Site #716
  • Tochigi, Japan, 326-0843
    • Clinical Research Site #726
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Clinical Research Site #705
    • Toyoake-shi, Aichi-ken, Japan, 470-1192
      • Clinical Research Site #709
  • Chiba
    • Chiba, Chiba, Japan, 260-8712
      • Clinical Research Site #700
    • Urayasu-shi, Chiba, Japan, 279-002
      • Clinical Research Site #707
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Clinical Research Site #724
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • Clinical Research Site #708
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 213-8587
      • Clinical Research Site #714
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Clinical Research Site #713
  • Oita Prefecture
    • Yufu, Oita Prefecture, Japan, 879-5593
      • Clinical Research Site #717
  • Tokyo
    • Bunkyo, Tokyo, Japan, 113-8431
      • Clinical Research Site #715
    • Nerima-ku, Tokyo, Japan, 177-8521
      • Clinical Research Site #727
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Clinical Research Site #123
  • Kuala Lumpur, Malaysia, 56000
    • Clinical Research Site #125
  • Kuala Lumpur, Malaysia, 59100
    • Clinical Research Site #121
  • Kuantan, Malaysia, 25100
    • Clinical Research Site #120
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Clinical Research Site #124
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 47150
      • Clinical Research Site #126
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud Universitair Medisch Centrum
• Philippines
  • Quezon City, Philippines, 1101
    • Clinical Research Site #132
  • Quezon City, Philippines, 1112
    • Clinical Research Site #131
• Poland
  • Krakow, Poland, 31-513
    • Clinical Research Site #535
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 92-213
      • Clinical Research Site #530
• Portugal
  • Braga, Portugal, 4710-243
    • Clinical Research Site #540
  • Carnaxide, Portugal, 2790-134
    • Clinical Research Site #545
  • Porto, Portugal, 4200-319
    • Clinical Research Site #544
  • Porto, Portugal, 4434-502
    • Clinical Research Site #543
• Singapore
  • Singapore, Singapore, 119074
    • Clinical Research Site #142
  • Singapore, Singapore, 169608
    • Clinical Research Site #141
  • Singapore, Singapore, 308433
    • Clinical Research Site #140
• South Korea
  • Anyang, South Korea, 14060
    • Clinical Research Site #104
  • Hwaseong-si, South Korea, 18450
    • Clinical Research Site #109
  • Seongnam, South Korea, 13620
    • Clinical Research Site #110
  • Seoul, South Korea, 134-727
    • Clinical Research Site #105
  • Seoul, South Korea, 3080
    • Clinical Research Site #107
  • Seoul, South Korea, 3722
    • Clinical Research Site #103
  • Seoul, South Korea, 5030
    • Clinical Research Site #108
  • Seoul, South Korea, 5355
    • Clinical Research Site #106
  • Busan Gwang'yeogsi
    • Busan, Busan Gwang'yeogsi, South Korea, 49241
      • Clinical Research Site #102
  • Daegu Gwang'yeogsi
    • Daegu, Daegu Gwang'yeogsi, South Korea, 41944
      • Clinical Research Site #112
  • Gwangju Gwang'yeogsi
    • Gwangju, Gwangju Gwang'yeogsi, South Korea, 61469
      • Clinical Research Site #113
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 18450
      • Clinical Research Site #111
    • Seoul, Seoul Teugbyeolsi, South Korea, 6351
      • Clinical Research Site #100
• Spain
  • Barcelona, Spain, 8025
    • Clinical Research Site #567
  • Barcelona, Spain, 8035
    • Clinical Research Site #566
  • Barcelona, Spain, 8907
    • Clinical Research Site #563
  • Córdoba, Spain, 14004
    • Clinical Research Site #565
  • Ellenboro, Spain, 28040
    • Clinical Research Site #564
  • Madrid, Spain, 28034
    • Clinical Research Site #573
  • Madrid, Spain, 28222
    • Clinical Research Site #570
  • Seville, Spain, 41009
    • Clinical Research Site #562
  • Seville, Spain, 41013
    • Clinical Research Site #561
• Sri Lanka
  • Colombo, Sri Lanka, 8
    • Clinical Research Site #151
  • Kandy, Sri Lanka, 20000
    • Clinical Research Site #152
  • Kurunegala, Sri Lanka, 60000
    • Clinical Research Site #154
  • Nugegoda, Sri Lanka, 10250
    • Clinical Research Site #150
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Clinical Research Site #161
  • Keelung, Taiwan, 20104
    • Clinical Research Site #160
  • New Taipei City, Taiwan, 23561
    • Clinical Research Site #163
  • Taipei, Taiwan, 10002
    • Clinical Research Site #164
  • Taipei, Taiwan, 112202
    • Clinical Research Site #165
• Thailand
  • Bangkok, Thailand, 10310
    • Clinical Research Site #170
  • Bangkok, Thailand, 1
    • Clinical Research Site #175
  • Chiang Mai, Thailand, 50200
    • Clinical Research Site #172
  • Din Daeng, Thailand, 10400
    • Clinical Research Site #171
  • Khon Kaen, Thailand, 40002
    • Clinical Research Site #173
• United Kingdom
  • Leicester, United Kingdom, LE5 4PW
    • Clinical Research Site #581
  • London, United Kingdom, E1 1FR
    • Clinical Research Site #584
  • London, United Kingdom, SE 5 9RS
    • Clinical Research Site #582
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Clinical Research Site #336
  • California
    • Los Angeles, California, United States, 90027
      • Clinical Research Site #325
    • Palo Alto, California, United States, 94304
      • Clinical Research Site #370
  • Colorado
    • Denver, Colorado, United States, 80220
      • Clinical Research Site #330
  • Florida
    • Lauderdale Lakes, Florida, United States, 33313
      • Clinical Research Site #323
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Clinical Research Site #373
    • Lawrenceville, Georgia, United States, 30046
      • Clinical Research Site #356
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Clinical Research Site #369
    • Worcester, Massachusetts, United States, 01655
      • Clinical Research Site #331
  • Michigan
    • Shelby, Michigan, United States, 48315
      • Clinical Research Site #320
  • New York
    • Great Neck, New York, United States, 11021
      • Clinical Research Site #346
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Clinical Research Site #350
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57029
      • Clinical Research Site #374
  • Texas
    • Houston, Texas, United States, 77030
      • Clinical Research Site #324
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53213
      • Clinical Research Site #361
• Vietnam
  • Hanoi, Vietnam
    • Clinical Research Site #181

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN.
• Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.

Exclusion Criteria:

• Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201.
• Subjects with treatment-limiting AEs during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement.
• Noncompliance, due to subject's repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject's eligibility.
• Subjects who have a positive pregnancy test result prior to receiving IMP.
• Heterosexually active biological males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject's participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter.
• Biological male subjects who do not agree to avoid donation of sperm from the time of consent through the end of the subject's participation in the trial and an additional 90 days thereafter.
• Subject has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema. Subjects with isolated nephrotic range proteinuria (> 3.5 g/day) will be eligible.
• Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, rheumatologic, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or ongoing malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
• History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema or anaphylaxis to any of the ingredients of the sibeprenlimab SC injection formulation.
• Subject has a body mass index < 16 kg/m^2.
• Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation).
• Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppressive therapy (ie, steroids such as targeted release budesonide, complement inhibitors, mycophenolate, rituximab). Note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids (<= 14 days) are allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sibeprenlimab 400 mg s.c. q 4 weeks	Drug: Sibeprenlimab 400 mg s.c. Q4weeks; Sibeprenlimab 400 mg s.c. q 4 weeks; Other Names: VIS649

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	From baseline to the end-of-trial visit in Week 112.

Secondary Outcome Measures

Outcome Measure	Time Frame
Annualized slope of Estimated Glomerular Filtration Rate (eGFR)	Over 12 and 24 months
Urine protein/creatinine ratio (uPCR) in a 24-hour collection	At 12 and 24 months
Proportion of Subjects with Clinical Remission as defined in the protocol	At 12 and 24 months
Time to Progression of Chronic Kidney Disease, as defined in the protocol	Over 24 months

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

Helpful Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Estimated): December 28, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: IgAN; VIS649; Sibeprenlimab
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: 417-201-00012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No