A Phase 2/3, Multicenter, Open‑label Trial to Evaluate the Long‑term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy.

Conditions

Treatment of IgAN

Brief summary

Safety and tolerability: Incidence of TEAEs graded by severity and as assessed by clinical laboratory tests, vital sign measurements, physical examinations, and injection site reactions.

Detailed description

The slope of eGFR over the course of approximately 12 and 24 months., Mean change of eGFR from baseline at 12 and 24 months., Overall rate of proteinuric remission, based on 24-hour urine collection, and defined as the proportion of subjects achieving urine total protein < 0.5 g/day at 12 and 24 months., Relative change from baseline in terms of uPCR at 12 and 24 months, based on 24-hour urine collection., Progression to CKF, as assessed by: - Time to progression to CKF (time from first IMP date to first occurrence of CKF). - Proportion of subjects with progression to CKF., Pharmacodynamics: Change from baseline in total serum IgA, IgG, and IgM concentrations., Other: Evaluation of serum ADA levels., Estimate the time-normalized AUC for eGFR at 12 and 24 months.

Related papers

No related papers found yet.

Interventions

DRUGSibeprenlimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety and tolerability: Incidence of TEAEs graded by severity and as assessed by clinical laboratory tests, vital sign measurements, physical examinations, and injection site reactions.	—

Secondary

Measure	Time frame
The slope of eGFR over the course of approximately 12 and 24 months., Mean change of eGFR from baseline at 12 and 24 months., Overall rate of proteinuric remission, based on 24-hour urine collection, and defined as the proportion of subjects achieving urine total protein < 0.5 g/day at 12 and 24 months., Relative change from baseline in terms of uPCR at 12 and 24 months, based on 24-hour urine collection., Progression to CKF, as assessed by: - Time to progression to CKF (time from first IMP date to first occurrence of CKF). - Proportion of subjects with progression to CKF., Pharmacodynamics: Change from baseline in total serum IgA, IgG, and IgM concentrations., Other: Evaluation of serum ADA levels., Estimate the time-normalized AUC for eGFR at 12 and 24 months.	—

Measure

Time frame

The slope of eGFR over the course of approximately 12 and 24 months., Mean change of eGFR from baseline at 12 and 24 months., Overall rate of proteinuric remission, based on 24-hour urine collection, and defined as the proportion of subjects achieving urine total protein < 0.5 g/day at 12 and 24 months., Relative change from baseline in terms of uPCR at 12 and 24 months, based on 24-hour urine collection., Progression to CKF, as assessed by: - Time to progression to CKF (time from first IMP date to first occurrence of CKF). - Proportion of subjects with progression to CKF., Pharmacodynamics: Change from baseline in total serum IgA, IgG, and IgM concentrations., Other: Evaluation of serum ADA levels., Estimate the time-normalized AUC for eGFR at 12 and 24 months.

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Countries

Belgium, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed