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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SCTC21C

    Biological/Vaccine

    Drug: SCTC21C Administered SC

Treatment groups

99 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Phase I: Dose-finding: Group 1Experimental treatment 1 intervention
Group B: Phase I: Dose-finding: Group 2Experimental treatment 1 intervention
Group C: Phase I: Dose-finding: Group 3Experimental treatment 1 intervention
Group D: Phase I: Dose-finding: Group 4Experimental treatment 1 intervention
Group E: Phase 2: Group 1Experimental treatment 1 intervention
Group F: Phase 2: Group 2Experimental treatment 1 intervention
Group G: Phase I: Dose-finding: Group 5Placebo comparator 1 intervention
Group H: Phase I: Dose-finding: Group 6Placebo comparator 1 intervention
Group I: Phase 1: Dose-finding: Group 7Placebo comparator 1 intervention
Group J: Phase 2: Group 3Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs).

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.

Time frame
36 Weeks
2

Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) at Week 24 compared to baseline

UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.

Time frame
24 Weeks

Secondary outcomes

1

Phase 1: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline

UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.

Time frame
36 Weeks
2

Phase 1: Percentage change in 24-hour urinary protein excretion compared to baseline

Time frame
36 Weeks
3

Phase 1: Percentage change in urine albumin-to-creatinine ratio (UACR) compared to baseline

UACR is calculated by dividing the concentration of albumin in urine by the urine creatinine concentration.

Time frame
36 Weeks
4

Phase 1: Percentage change in eGFR compared to baseline

eGFR is calculated using the CKD-EPI formula.

Time frame
36 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: