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NOT YET RECRUITING
NCT07553494
PHASE2

SLN12140 in Adult Participants With IgA Nephropathy in China

Sponsor: Linno Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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).

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SLN12140 in Adult Patients With Primary IgA Nephropathy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-05-29

Completion Date

2028-12

Last Updated

2026-04-28

Healthy Volunteers

No

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.

Locations (1)

Beijing University 1st hospital

Beijing, Beijing Municipality, China