Date

2025-02-22

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

Subjects who have not completed participation in trials 417-201-00007 or VIS649-201. Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement that would preclude rollover into this trial

Next Version

1) Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201. 2) Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement. 3) 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. 4) Subjects who have a positive pregnancy test result prior to receiving IMP. 5) 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. 6) 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. 7) 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. 8) 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. 9) 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. 10) Subject has a body mass index < 16 kg/m2 . 11) Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation). 12) Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppression (note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids [? 14 days] are allowed). 13) Subject has participated in another interventional clinical trial (other than Trials 417-201-00007 and VIS649-201) and received another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer. 14) Subject has any chronic infectious disease (eg, chronic urinary tract infection; chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B [defined as positive for hepatitis B surface antigen]; or human immunodeficiency virus [HIV] infection). 15) Subject has acute infectious disease at the time of screening. Note: Enrollment can be considered if the acute infection has resolved within the screening window, defined as resolution of acute clinical signs, symptoms, and related clinical laboratory parameters. Consultation between the trial site investigator and the medical monitor and/or sponsor should occur in case of any questions. 16) Subject has Type 1 diabetes. 17) Subject has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c (HbA1c) value > 8%. Subjects will be excluded if their anti-diabetic regimen is not stable. A stable anti-diabetic regimen is defined as either diet and exercise therapy alone or in combination with any approved anti-diabetic medication in which the doses of oral or noninsulin injectable medications have not changed during the 8 weeks prior to enrollment; or the doses of long-acting insulin or intermediate-acting insulin have not varied by more than 20% during the 8 weeks prior to enrollment. 18) Subject has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg). 19) Subject who has a recent history (ie, within the past year) of alcohol or drug/chemical abuse that would, based on the investigator’s clinical judgement, interfere with the subject’s ability to participate in the trial. 20) Subject is judged by the investigator or the medical monitor to be inappropriate for the trial. 21) Subjects receiving any of the prohibited medications within the specified periods or who would be likely to require prohibited concomitant therapy during the trial.