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)
Adverse Events — From baseline to the end-of-trial visit in Week 112.
Trial sites (158)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.