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.
1 other identifier
interventional
600
31 countries
158
Brief Summary
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2022
Longer than P75 for phase_2
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
May 5, 2026
April 1, 2026
6.7 years
February 18, 2022
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
From baseline to the end-of-trial visit in Week 112.
Secondary Outcomes (4)
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
Study Arms (1)
Sibeprenlimab 400 mg s.c. q 4 weeks
EXPERIMENTALInterventions
Sibeprenlimab 400 mg s.c. q 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (158)
Clinical Research Site #336
Birmingham, Alabama, 35233, United States
Clinical Research Site #325
Los Angeles, California, 90027, United States
Clinical Research Site #370
Palo Alto, California, 94304, United States
Clinical Research Site #330
Denver, Colorado, 80220, United States
Clinical Research Site #323
Lauderdale Lakes, Florida, 33313, United States
Clinical Research Site #373
Atlanta, Georgia, 30342, United States
Clinical Research Site #356
Lawrenceville, Georgia, 30046, United States
Clinical Research Site #369
Boston, Massachusetts, 02114, United States
Clinical Research Site #331
Worcester, Massachusetts, 01655, United States
Clinical Research Site #320
Shelby, Michigan, 48315, United States
Clinical Research Site #346
Great Neck, New York, 11021, United States
Clinical Research Site #350
Columbus, Ohio, 43210, United States
Clinical Research Site #374
Dakota Dunes, South Dakota, 57029, United States
Clinical Research Site #324
Houston, Texas, 77030, United States
Clinical Research Site #361
Milwaukee, Wisconsin, 53213, United States
Clinical Research Site #800
Buenos Aires, C1280AEB, Argentina
Clinical Research Site #802
Buenos Aires, C1425, Argentina
Clinical Research Site #801
Córdoba, X5016LIG, Argentina
Clinical Research Site #003
Garran, Australian Capital Territory, 2605, Australia
Clinical Research Site #013
Concord, New South Wales, 2139, Australia
Clinical Research Site #014
Kogarah, New South Wales, 2217, Australia
Clinical Research Site
New Lambton Heights, New South Wales, 2305, Australia
Clinical Research Site #006
Saint Leonards, New South Wales, 2065, Australia
Clinical Research Site #012
Adelaide, South Australia, 5000, Australia
Clinical Research Site #001
Fitzroy, Victoria, 3065, Australia
Clinical Research Site #010
St Albans, Victoria, 3021, Australia
Clinical Research Site #011
Liverpool, 2170, Australia
Clinical Research Site #401
Genk, 3600, Belgium
Clinical Research Site #405
Genk, 3600, Belgium
Clinical Research Site #820
Recife, Pernambuco, 50670-901, Brazil
Clinical Research Site #824
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Clinical Research Site #821
Joinville, Santa Catarina, 89227-680, Brazil
Clinical Research Site #822
São José do Rio Preto, So Paulo, 15090-000, Brazil
Clinical Research Site #831
Rio de Janeiro, 20550-010, Brazil
Clinical Research Site #823
São Paulo, 01246-903, Brazil
Clinical Research Site #300
Calgary, Alberta, T2R 0X7, Canada
Clinical Research Site #305
Scarborough Village, Ontario, M1H 3G4, Canada
CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Clinical Research Site #036
Beijing, Beijing Municipality, 100029, China
Clinical Research Site #020
Beijing, Beijing Municipality, 100034, China
Clinical Research Site #028
Guangzhou, Guangdong, 510120, China
Clinical Research Site #044
Changsha, Hunan, 410011, China
Clinical Research Site #030
Wuxi, Jiangsu, 214023, China
Clinical Research Site #022
Nanchang, Jiangxi, 330006, China
Clinical Research Site #026
Jinan, Shandong, 250013, China
Clinical Research Site #038
Chengdu, Sichuan, 610072, China
Clinical Research Site #025
Yibin, Sichuan, 644002, China
Clinical Research Site #413
Split, 21000, Croatia
Clinical Research Site #414
Zagreb, 10000, Croatia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Clinical Research Site #433
Grenoble, Auvergne-Rhône-Alpes, 38043, France
Clinical Research Site #430
Nîmes, Gard, 30900, France
Clinical Research Site #432
Nantes, Loire-Atlantique, 44093, France
Clinical Research Site #439
Limoges, New Aquitaine, 87000, France
Clinical Research Site #434
Sr Priest En Jarez, Pays de la Loire Region, 42270, France
Clinical Research Site #455
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, Saxony, 1307, Germany
Clinical Research Site #472
Heraklion, 71110, Greece
Clinical Research Site #064
Hong Kong, New Territories, Hong Kong
Clinical Research Site #060
Hong Kong, 999077, Hong Kong
Clinical Research Site #061
Hong Kong, 999077, Hong Kong
Clinical Research Site #062
Kowloon, 999077, Hong Kong
Clinical Research Site #063
Shatin, 999077, Hong Kong
Clinical Research Site #482
Pécs, Baranya, 7624, Hungary
Clinical Research Site #081
Hyderabad, Deccan, 500082, India
Clinical Research Site #073
Ahmedabad, Gujarat, 382421, India
Clinical Research Site #070
Nadiād, Gujarat, 387001, India
Clinical Research Site #087
Bengaluru, Karnataka, 560099, India
Clinical Research Site #079
Manipal, Karnataka, 576104, India
Clinical Research Site #071
Kozhikode, Kerala, 673008, India
Clinical Research Site #074
Thiruvananthapuram, Kerala, 695011, India
Clinical Research Site #084
Pune, Maharashtra, 411057, India
Clinical Research Site #075
New Delhi, National Capital Territory of Delhi, 1100060, India
Clinical Research Site #077
Chandigarh, Punjab, 160012, India
Clinical Research Site #080
Rajipet, Tamil Nadu, 632517, India
Clinical Research Site #078
Afzalganj, Telangana, 500012, India
Clinical Research Site #076
Lucknow, Uttar Pradesh, 226014, India
Clinical Research Site #494
Ashkelon, 7830604, Israel
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital)
Kfar Saba, 44281, Israel
Clinical Research Site #495
Nahariya, 22100, Israel
Clinical Research Site #493
Petach Tiqwa, 49100, Israel
Clinical Research Site #512
Bologna, 40138, Italy
Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
Clinical Research Site #509
Pavia, 27100, Italy
Clinical Research Site #507
Piacenza, 29121, Italy
Clinical Research Site #705
Nagoya, Aichi-ken, 466-8560, Japan
Clinical Research Site #709
Toyoake-shi, Aichi-ken, 470-1192, Japan
Clinical Research Site #700
Chiba, Chiba, 260-8712, Japan
Clinical Research Site #707
Urayasu-shi, Chiba, 279-002, Japan
Clinical Research Site #724
Kobe, Hyōgo, 650-0017, Japan
Clinical Research Site #708
Tsukuba, Ibaraki, 305-8576, Japan
Clinical Research Site #714
Kawasaki-shi, Kanagawa, 213-8587, Japan
Clinical Research Site #713
Kashihara, Nara, 634-8522, Japan
Clinical Research Site #717
Yufu, Oita Prefecture, 879-5593, Japan
Clinical Research Site #715
Bunkyo, Tokyo, 113-8431, Japan
Clinical Research Site #727
Nerima-ku, Tokyo, 177-8521, Japan
Clinical Research Site #703
Fukuoka, 812-8582, Japan
Clinical Research Site #712
Minatoku, 105-8471, Japan
Clinical Research Site #716
Miyazaki, 889-1692, Japan
Clinical Research Site #726
Tochigi, 326-0843, Japan
Clinical Research Site #124
Ipoh, Perak, 30450, Malaysia
Clinical Research Site #126
Petaling Jaya, Selangor, 47150, Malaysia
Clinical Research Site #123
Kuala Lumpur, 50586, Malaysia
Clinical Research Site #125
Kuala Lumpur, 56000, Malaysia
Clinical Research Site #121
Kuala Lumpur, 59100, Malaysia
Clinical Research Site #120
Kuantan, 25100, Malaysia
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6500 HB, Netherlands
Clinical Research Site #132
Quezon City, 1101, Philippines
Clinical Research Site #131
Quezon City, 1112, Philippines
Clinical Research Site #535
Krakow, 31-513, Poland
Clinical Research Site #530
Lodz, Łódź Voivodeship, 92-213, Poland
Clinical Research Site #540
Braga, 4710-243, Portugal
Clinical Research Site #545
Carnaxide, 2790-134, Portugal
Clinical Research Site #544
Porto, 4200-319, Portugal
Clinical Research Site #543
Porto, 4434-502, Portugal
Clinical Research Site #142
Singapore, 119074, Singapore
Clinical Research Site #141
Singapore, 169608, Singapore
Clinical Research Site #140
Singapore, 308433, Singapore
Clinical Research Site #102
Busan, Busan Gwang'yeogsi, 49241, South Korea
Clinical Research Site #112
Daegu, Daegu Gwang'yeogsi, 41944, South Korea
Clinical Research Site #113
Gwangju, Gwangju Gwang'yeogsi, 61469, South Korea
Clinical Research Site #111
Seoul, Seoul Teugbyeolsi, 18450, South Korea
Clinical Research Site #100
Seoul, Seoul Teugbyeolsi, 6351, South Korea
Clinical Research Site #104
Anyang, 14060, South Korea
Clinical Research Site #109
Hwaseong-si, 18450, South Korea
Clinical Research Site #110
Seongnam, 13620, South Korea
Clinical Research Site #105
Seoul, 134-727, South Korea
Clinical Research Site #107
Seoul, 3080, South Korea
Clinical Research Site #103
Seoul, 3722, South Korea
Clinical Research Site #108
Seoul, 5030, South Korea
Clinical Research Site #106
Seoul, 5355, South Korea
Clinical Research Site #567
Barcelona, 8025, Spain
Clinical Research Site #566
Barcelona, 8035, Spain
Clinical Research Site #563
Barcelona, 8907, Spain
Clinical Research Site #565
Córdoba, 14004, Spain
Clinical Research Site #564
Ellenboro, 28040, Spain
Clinical Research Site #573
Madrid, 28034, Spain
Clinical Research Site #570
Madrid, 28222, Spain
Clinical Research Site #562
Seville, 41009, Spain
Clinical Research Site #561
Seville, 41013, Spain
Clinical Research Site #151
Colombo, 8, Sri Lanka
Clinical Research Site #152
Kandy, 20000, Sri Lanka
Clinical Research Site #154
Kurunegala, 60000, Sri Lanka
Clinical Research Site #150
Nugegoda, 10250, Sri Lanka
Clinical Research Site #161
Kaohsiung City, 83301, Taiwan
Clinical Research Site #160
Keelung, 20104, Taiwan
Clinical Research Site #163
New Taipei City, 23561, Taiwan
Clinical Research Site #164
Taipei, 10002, Taiwan
Clinical Research Site #165
Taipei, 112202, Taiwan
Clinical Research Site #170
Bangkok, 10310, Thailand
Clinical Research Site #175
Bangkok, 1, Thailand
Clinical Research Site #172
Chiang Mai, 50200, Thailand
Clinical Research Site #171
Din Daeng, 10400, Thailand
Clinical Research Site #173
Khon Kaen, 40002, Thailand
Clinical Research Site #581
Leicester, LE5 4PW, United Kingdom
Clinical Research Site #584
London, E1 1FR, United Kingdom
Clinical Research Site #582
London, SE 5 9RS, United Kingdom
Clinical Research Site #181
Hanoi, 0, Vietnam
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2022
First Posted
February 21, 2022
Study Start
April 5, 2022
Primary Completion (Estimated)
December 28, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
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.