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Clinical Trials in the USA / NCT05248659
Enrolling by invitation Phase 2/3

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

NCT05248659 · tracked via the Priya Life Science USA tracker
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 2/3
Started
2022-04-05
Last updated
2026-05-05

Condition(s) studied

Immunoglobulin A Nephropathy

Investigational drug(s) / intervention(s)

Sibeprenlimab 400 mg s.c. Q4weeks

Sibeprenlimab 400 mg s.c. Q4weeks: Sibeprenlimab 400 mg s.c. q 4 weeks

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (158)

FacilityCityRegionStatus
Clinical Research Site #336 Birmingham Alabama
Clinical Research Site #325 Los Angeles California
Clinical Research Site #370 Palo Alto California
Clinical Research Site #330 Denver Colorado
Clinical Research Site #323 Lauderdale Lakes Florida
Clinical Research Site #373 Atlanta Georgia
Clinical Research Site #356 Lawrenceville Georgia
Clinical Research Site #369 Boston Massachusetts
Clinical Research Site #331 Worcester Massachusetts
Clinical Research Site #320 Shelby Michigan
Clinical Research Site #346 Great Neck New York
Clinical Research Site #350 Columbus Ohio
Clinical Research Site #374 Dakota Dunes South Dakota
Clinical Research Site #324 Houston Texas
Clinical Research Site #361 Milwaukee Wisconsin
Clinical Research Site #800 Buenos Aires Argentina
Clinical Research Site #802 Buenos Aires Argentina
Clinical Research Site #801 Córdoba Argentina
Clinical Research Site #003 Garran Australian Capital Territory
Clinical Research Site #013 Concord New South Wales
Clinical Research Site #014 Kogarah New South Wales
Clinical Research Site New Lambton Heights New South Wales
Clinical Research Site #006 Saint Leonards New South Wales
Clinical Research Site #012 Adelaide South Australia
Clinical Research Site #001 Fitzroy Victoria
Clinical Research Site #010 St Albans Victoria
Clinical Research Site #011 Liverpool Australia
Clinical Research Site #401 Genk Belgium
Clinical Research Site #405 Genk Belgium
Clinical Research Site #820 Recife Pernambuco
Clinical Research Site #824 Porto Alegre Rio Grande do Sul
Clinical Research Site #821 Joinville Santa Catarina
Clinical Research Site #822 São José do Rio Preto So Paulo
Clinical Research Site #831 Rio de Janeiro Brazil
Clinical Research Site #823 São Paulo Brazil
Clinical Research Site #300 Calgary Alberta
Clinical Research Site #305 Scarborough Village Ontario
CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne Greenfield Park Quebec
Clinical Research Site #036 Beijing Beijing Municipality
Clinical Research Site #020 Beijing Beijing Municipality

+ 118 more sites — see the full list on the official registry below.

More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05248659 on ClinicalTrials.gov ↗ ← All trials in the USA