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

Sponsor ID
417-201-00012
Clinicaltrials.gov ID
NCT05248659
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Recruiting
Sponsor ID
417-201-00012
Trial Details
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Age
18+ years
Therapeutic Area
  • Autoimmune Disease
    • Sex
    Female & Male
    Trial Dates
    Apr 2022 - Dec 2028
    Healthy Volunteers
    No
    • 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.
    • 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 Summary

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

    Additional Study Details

    Phase
    Phase 2/Phase 3
    Study Drug
    Drug: Sibeprenlimab 400 mg s.c. Q4weeks
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    600
    Additional Study Details

    Inclusion and Exclusion Criteria

    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.
    Inclusion and Exclusion Criteria
    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.

    Locations

    Location
    Status
    Location
    Clinical Research Site #336
    Birmingham, Alabama, United States, 35233
    Status
    N/A
    Location
    Clinical Research Site #325
    Los Angeles, California, United States, 90027
    Status
    N/A
    Location
    Clinical Research Site #370
    Palo Alto, California, United States, 94304
    Status
    N/A
    Location
    Clinical Research Site #330
    Denver, Colorado, United States, 80220
    Status
    N/A
    Location
    Clinical Research Site #323
    Lauderdale Lakes, Florida, United States, 33313
    Status
    N/A
    Location
    Clinical Research Site #373
    Atlanta, Georgia, United States, 30342
    Status
    N/A
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