The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort. Approximately 42 participants with IgAN will be enrolled in 2 stages: Stage 1 will be used to collect safety, immunogenicity, PK, and PD data to select the optimal biologic dose (OBD) of KP104 for IgAN, as well as to preliminarily explore the effect of KP104 on C3G. Stage 2 will be used to collect safety, immunogenicity, PK, PD, and efficacy data at the OBD dose of KP104 for IgAN and C3G. As soon as the OBD for IgAN is determined, eligible participants with C3G will be enrolled and dosed at the OBD for IgAN for a minimum of 48 weeks for weekly maintenance dosing and a minimum of 47 weeks for biweekly maintenance dosing. Approximately 10 participants with C3G will be enrolled.
Weight of >35 kilograms (kg) at Screening
Body mass index (BMI) of <35 kilograms per square meter (kg/m²)
UPCR >1.0 grams per gram (g/g) by 24-hour urine collection at Screening
Diagnosis of IgAN verified by biopsy taken within the past 3 years prior to enrolment.
Any clinically significant, poorly controlled underlying illness other than IgAN or C3G, as determined by the investigator
Treatment of any infection with IV (within 30 days of Screening) or oral (within 14 days of Screening) antibiotics, antivirals, or antifungals
History of infections with encapsulated organisms
History of untreated tuberculosis
Sequential
KP104
DrugParticipants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104.
6
Treatment groupsSee each treatment group below.
Percent change from Baseline in 24-hour urinary protein creatinine ratio (UPCR) at Week 24 (C3G) for participants in Stage 2
The UPCR will be calculated as percent change in protein (Pr)/ Creatinine (Cr).
Number of participants reporting Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. A TEAE is defined as any AE that started or worsened in severity on or after the first dose of study treatment.
Number of participants reporting Treatment-Emergent Serious Adverse Events (TESAEs)
A TESAE is defined as a serious AE (SAE) that started or worsened in severity on or after the first dose of study treatment.
Number of participants reporting AEs of Special Interest (AESIs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. Number of participants with AESIs including infections and local or systemic administration reactions will be assessed.
Maximum concentration (Cmax) of KP104
Blood samples will collected at indicated timepoints to assess Cmax.
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