A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune Diseases
ConditionIgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.
About this trial
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases
Eligibility criteria
Qualifiers
Age ≥18 years at the time of signing the ICF;
The subject has been diagnosed with IgA nephropathy through kidney tissue biopsy;
The subject has been on a stable and maximally tolerated dose of ACEI or ARB (or the maximum allowable dose according to the prescribing information) for at least 12 weeks prior to the first dose. Subjects using both ACEI and ARB simultaneously will not be accepted;
The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula must be ≥30 mL/min/1.73 m²;
Disqualifiers
IgA nephropathy secondary to other diseases;
Any kidney disease with special pathological or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis, etc.;
Use of systemic corticosteroids within the 3 months prior to baseline or expected use during the study period;
Use of systemic immunosuppressive drugs within the 3 months prior to baseline or expected use during the study period;
Trial design
Treatments tested in this trial
- SCTC21C
Treatment groups
99 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov