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SLN12140 in Adult Participants With IgA Nephropathy in China

NCT07553494 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-28

No results posted yet for this study

Summary

This study is a randomized, parallel, double-blind, placebo-controlled, subcutaneous administration Phase II dose-exploration clinical trial aimed at evaluating the efficacy, safety, PK, PD, and immunogenicity characteristics of SLN12140 at different doses in IgA nephropathy subjects who have previously received standard treatment (the standard treatment drugs allowed in this study include: angiotensin-converting enzyme inhibitors \[ACEi\], angiotensin II receptor blockers \[ARB\], and sodium-glucose co-transporter 2 inhibitors \[SGLT2i\]) but have poor control.

The study is divided into four stages, including a screening period of up to 8 weeks, an introduction period of up to 12 weeks, a 40-week double-blind period (including a 36-week treatment period and a 4-week safety follow-up period; all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will enter the open-label extension period for continued treatment after completing the double-blind period), and a 56-week open-label extension period (all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will continue SLN12140 at the same dose group \[the optimal dose\], including a 52-week open treatment period and a 4-week safety follow-up period).

Conditions

  • IgA Nephropathy (IgAN)

Interventions

DRUG

SLN12140

SLN12140 by subcutaneous (sc) injection:100mg QW for 36 weeks in blind treatment period; SLN12140 by subcutaneous (sc) injection:200mg QW for 36 weeks in blind treatment period; SLN12140 by subcutaneous (sc) injection:600mg Q4W for 36 weeks in blind treatment period; after 36 weeks of blind treatment period, all of subjects will receive SLN12140 treatment for 52 weeks as open-label extension period with one optimal dosage.

OTHER

Placebo

Placebo (0.9% sodium chloride solution) will be provided as an injectable solution without active ingredient for 36 weeks in blind treatment period.

Sponsors & Collaborators

  • Linno Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Hong ZHANG, Professor · Beijing University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553494 on ClinicalTrials.gov