Immunoglobulin A NephropathyPhase 2/3NCT05248659
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
A Phase 2/3 study testing Sibeprenlimab 400 mg s.c. Q4weeks in people with Immunoglobulin A Nephropathy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 158 sites in 31 countries.
Trial summary
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy
- What is being tested?
- Sibeprenlimab 400 mg s.c. Q4weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 158 sitesin 31 countries
- Study dates
- 5 Apr 2022to 31 Dec 2029
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
158 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
158 sites in 31 countries
United States15 sites
Clinical Research Site #373
Atlanta, Georgia, 30342
Clinical Research Site #336
Birmingham, Alabama, 35233
Clinical Research Site #369
Boston, Massachusetts, 02114
Clinical Research Site #350
Columbus, Ohio, 43210
Clinical Research Site #374
Dakota Dunes, South Dakota, 57029
Clinical Research Site #330
Denver, Colorado, 80220
Clinical Research Site #346
Great Neck, New York, 11021
Clinical Research Site #324
Houston, Texas, 77030
Clinical Research Site #323
Lauderdale Lakes, Florida, 33313
Clinical Research Site #356
Lawrenceville, Georgia, 30046
Clinical Research Site #325
Los Angeles, California, 90027
Clinical Research Site #361
Milwaukee, Wisconsin, 53213
Clinical Research Site #370
Palo Alto, California, 94304
Clinical Research Site #320
Shelby, Michigan, 48315
Clinical Research Site #331
Worcester, Massachusetts, 01655
Japan15 sites
Clinical Research Site #715
Bunkyo, Tokyo, 113-8431
Clinical Research Site #700
Chiba, Chiba, 260-8712
Clinical Research Site #703
Fukuoka, 812-8582
Clinical Research Site #713
Kashihara, Nara, 634-8522
Clinical Research Site #714
Kawasaki-shi, Kanagawa, 213-8587
Clinical Research Site #724
Kobe, Hyōgo, 650-0017
Clinical Research Site #712
Minatoku, 105-8471
Clinical Research Site #716
Miyazaki, 889-1692
Clinical Research Site #705
Nagoya, Aichi-ken, 466-8560
Clinical Research Site #727
Nerima-ku, Tokyo, 177-8521
Clinical Research Site #726
Tochigi, 326-0843
Clinical Research Site #709
Toyoake-shi, Aichi-ken, 470-1192
Clinical Research Site #708
Tsukuba, Ibaraki, 305-8576
Clinical Research Site #707
Urayasu-shi, Chiba, 279-002
Clinical Research Site #717
Yufu, Oita Prefecture, 879-5593
India13 sites
Clinical Research Site #078
Afzalganj, Telangana, 500012
Clinical Research Site #073
Ahmedabad, Gujarat, 382421
Clinical Research Site #087
Bengaluru, Karnataka, 560099
Clinical Research Site #077
Chandigarh, Punjab, 160012
Clinical Research Site #081
Hyderabad, Deccan, 500082
Clinical Research Site #071
Kozhikode, Kerala, 673008
Clinical Research Site #076
Lucknow, Uttar Pradesh, 226014
Clinical Research Site #079
Manipal, Karnataka, 576104
Clinical Research Site #070
Nadiād, Gujarat, 387001
Clinical Research Site #075
New Delhi, National Capital Territory of Delhi, 1100060
Clinical Research Site #084
Pune, Maharashtra, 411057
Clinical Research Site #080
Rajipet, Tamil Nadu, 632517
Clinical Research Site #074
Thiruvananthapuram, Kerala, 695011
South Korea13 sites
Clinical Research Site #104
Anyang, 14060
Clinical Research Site #102
Busan, Busan Gwang'yeogsi, 49241
Clinical Research Site #112
Daegu, Daegu Gwang'yeogsi, 41944
Clinical Research Site #113
Gwangju, Gwangju Gwang'yeogsi, 61469
Clinical Research Site #109
Hwaseong-si, 18450
Clinical Research Site #110
Seongnam, 13620
Clinical Research Site #111
Seoul, Seoul Teugbyeolsi, 18450
Clinical Research Site #100
Seoul, Seoul Teugbyeolsi, 6351
Clinical Research Site #105
Seoul, 134-727
Clinical Research Site #107
Seoul, 3080
Clinical Research Site #103
Seoul, 3722
Clinical Research Site #108
Seoul, 5030
Clinical Research Site #106
Seoul, 5355
Australia9 sites
Clinical Research Site #012
Adelaide, South Australia, 5000
Clinical Research Site #013
Concord, New South Wales, 2139
Clinical Research Site #001
Fitzroy, Victoria, 3065
Clinical Research Site #003
Garran, Australian Capital Territory, 2605
Clinical Research Site #014
Kogarah, New South Wales, 2217
Clinical Research Site #011
Liverpool, 2170
Clinical Research Site
New Lambton Heights, New South Wales, 2305
Clinical Research Site #006
Saint Leonards, New South Wales, 2065
Clinical Research Site #010
St Albans, Victoria, 3021
China9 sites
Clinical Research Site #036
Beijing, Beijing Municipality, 100029
Clinical Research Site #020
Beijing, Beijing Municipality, 100034
Clinical Research Site #044
Changsha, Hunan, 410011
Clinical Research Site #038
Chengdu, Sichuan, 610072
Clinical Research Site #028
Guangzhou, Guangdong, 510120
Clinical Research Site #026
Jinan, Shandong, 250013
Clinical Research Site #022
Nanchang, Jiangxi, 330006
Clinical Research Site #030
Wuxi, Jiangsu, 214023
Clinical Research Site #025
Yibin, Sichuan, 644002
Spain9 sites
Clinical Research Site #567
Barcelona, 8025
Clinical Research Site #566
Barcelona, 8035
Clinical Research Site #563
Barcelona, 8907
Clinical Research Site #565
Córdoba, 14004
Clinical Research Site #564
Ellenboro, 28040
Clinical Research Site #573
Madrid, 28034
Clinical Research Site #570
Madrid, 28222
Clinical Research Site #562
Seville, 41009
Clinical Research Site #561
Seville, 41013
Brazil6 sites
Clinical Research Site #821
Joinville, Santa Catarina, 89227-680
Clinical Research Site #824
Porto Alegre, Rio Grande do Sul, 90020-090
Clinical Research Site #820
Recife, Pernambuco, 50670-901
Clinical Research Site #831
Rio de Janeiro, 20550-010
Clinical Research Site #822
São José do Rio Preto, So Paulo, 15090-000
Clinical Research Site #823
São Paulo, 01246-903
Malaysia6 sites
Clinical Research Site #124
Ipoh, Perak, 30450
Clinical Research Site #123
Kuala Lumpur, 50586
Clinical Research Site #125
Kuala Lumpur, 56000
Clinical Research Site #121
Kuala Lumpur, 59100
Clinical Research Site #120
Kuantan, 25100
Clinical Research Site #126
Petaling Jaya, Selangor, 47150
France5 sites
Clinical Research Site #433
Grenoble, Auvergne-Rhône-Alpes, 38043
Clinical Research Site #439
Limoges, New Aquitaine, 87000
Clinical Research Site #432
Nantes, Loire-Atlantique, 44093
Clinical Research Site #430
Nîmes, Gard, 30900
Clinical Research Site #434
Sr Priest En Jarez, Pays de la Loire Region, 42270
Hong Kong5 sites
Clinical Research Site #064
Hong Kong, New Territories
Clinical Research Site #060
Hong Kong, 999077
Clinical Research Site #061
Hong Kong, 999077
Clinical Research Site #062
Kowloon, 999077
Clinical Research Site #063
Shatin, 999077
Taiwan5 sites
Clinical Research Site #161
Kaohsiung City, 83301
Clinical Research Site #160
Keelung, 20104
Clinical Research Site #163
New Taipei City, 23561
Clinical Research Site #164
Taipei, 10002
Clinical Research Site #165
Taipei, 112202
Thailand5 sites
Clinical Research Site #170
Bangkok, 10310
Clinical Research Site #175
Bangkok, 1
Clinical Research Site #172
Chiang Mai, 50200
Clinical Research Site #171
Din Daeng, 10400
Clinical Research Site #173
Khon Kaen, 40002
Israel4 sites
Clinical Research Site #494
Ashkelon, 7830604
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital)
Kfar Saba, 44281
Clinical Research Site #495
Nahariya, 22100
Clinical Research Site #493
Petach Tiqwa, 49100
Italy4 sites
Clinical Research Site #512
Bologna, 40138
Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino
Genova, 16132
Clinical Research Site #509
Pavia, 27100
Clinical Research Site #507
Piacenza, 29121
Portugal4 sites
Clinical Research Site #540
Braga, 4710-243
Clinical Research Site #545
Carnaxide, 2790-134
Clinical Research Site #544
Porto, 4200-319
Clinical Research Site #543
Porto, 4434-502
Sri Lanka4 sites
Clinical Research Site #151
Colombo, 8
Clinical Research Site #152
Kandy, 20000
Clinical Research Site #154
Kurunegala, 60000
Clinical Research Site #150
Nugegoda, 10250
Argentina3 sites
Clinical Research Site #800
Buenos Aires, C1280AEB
Clinical Research Site #802
Buenos Aires, C1425
Clinical Research Site #801
Córdoba, X5016LIG
Canada3 sites
Clinical Research Site #300
Calgary, Alberta, T2R 0X7
CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Clinical Research Site #305
Scarborough Village, Ontario, M1H 3G4
Singapore3 sites
Clinical Research Site #142
Singapore, 119074
Clinical Research Site #141
Singapore, 169608
Clinical Research Site #140
Singapore, 308433
United Kingdom3 sites
Clinical Research Site #581
Leicester, LE5 4PW
Clinical Research Site #584
London, E1 1FR
Clinical Research Site #582
London, SE 5 9RS
Belgium2 sites
Clinical Research Site #401
Genk, 3600
Clinical Research Site #405
Genk, 3600
Croatia2 sites
Clinical Research Site #413
Split, 21000
Clinical Research Site #414
Zagreb, 10000
Germany2 sites
Universitaetsklinikum Carl Gustav Carus
Dresden, Saxony, 1307
Clinical Research Site #455
Mainz, Rhineland-Palatinate, 55131
Philippines2 sites
Clinical Research Site #132
Quezon City, 1101
Clinical Research Site #131
Quezon City, 1112
Poland2 sites
Clinical Research Site #535
Krakow, 31-513
Clinical Research Site #530
Lodz, Łódź Voivodeship, 92-213
Netherlands1 site
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6500 HB
About this study
Official title: 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
Read the 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.
- Conditions
- Immunoglobulin A Nephropathy
- Being tested
- Sibeprenlimab 400 mg s.c. Q4weeks
- Keywords
- Sibeprenlimab, VIS649, IgAN
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sibeprenlimab 400 mg s.c. Q4weeksDrug
Also called VIS649
Sibeprenlimab 400 mg s.c. q 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sibeprenlimab 400 mg s.c. q 4 weeks | Experimental | Not described Receives: Drug: Sibeprenlimab 400 mg s.c. Q4weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: From baseline to the end-of-trial visit in Week 112.
Secondary outcomes (4)
Annualized slope of Estimated Glomerular Filtration Rate (eGFR)
Measured: Over 12 and 24 months
Urine protein/creatinine ratio (uPCR) in a 24-hour collection
Measured: At 12 and 24 months
Proportion of Subjects with Clinical Remission as defined in the protocol
Measured: At 12 and 24 months
Time to Progression of Chronic Kidney Disease, as defined in the protocol
Measured: Over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start5 Apr 2022
- Primary completion28 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A NephropathyStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248659
- Sponsor's protocol ID
- 417-201-00012
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.