A Study of SHR-2173 in Participants With Primary IgA Nephropathy

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy

This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.

Study Overview

• Status: Recruiting
• Conditions: Primary IgA Nephropathy
• Intervention / Treatment: Drug: Placebo; Drug: SHR-2173 injection; Drug: SHR-2173 injection; Drug: SHR-2173 injection

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kunming Li; Phone Number: 0518-82342973; Email: kunming.li@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Principal Investigator: Wei Chen
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Principal Investigator: Jingyuan Xie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female participants aged 18 or older
2. Body weight ≥35 kg, BMI<37.5 kg/m2
3. At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g
4. eGFR≥30 mL/ minute /1.73 m2 at screening
5. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol

Exclusion Criteria:

-

1、Presence of any of the following medical histories or comorbidities:

1. Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;
2. A history of organ transplantation;
3. A history of splenectomy;
4. Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);
5. A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug

2、Use of any of the following drugs/treatments or participation in a clinical study:

1. Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg/kg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks);
2. Receivied immunosuppressive therapy within 12 weeks before randomization;
3. Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;
4. Received a live / attenuated live vaccine administered within 4 weeks before randomization

3、History and examination related to infection:

1. A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and/or parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization;

2. Tuberculosis (TB) or occult TB infection (one of the following conditions) :

   1. Presence of active TB or clinical symptoms of active TB at screening;

   2. Signs of active TB on imaging examination within 3 months before screening

      4、 General situation:

1) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Drug: Placebo; Placebo
Experimental: Treatment group A: SHR-2173 injection	Drug: SHR-2173 injection; SHR-2173 injection；High dose; Drug: SHR-2173 injection; SHR-2173 injection；Medium dose; Drug: SHR-2173 injection; SHR-2173 injection；Low dose
Experimental: Treatment group B: SHR-2173 injection	Drug: SHR-2173 injection; SHR-2173 injection；High dose; Drug: SHR-2173 injection; SHR-2173 injection；Medium dose; Drug: SHR-2173 injection; SHR-2173 injection；Low dose
Experimental: Treatment group C: SHR-2173 injection	Drug: SHR-2173 injection; SHR-2173 injection；High dose; Drug: SHR-2173 injection; SHR-2173 injection；Medium dose; Drug: SHR-2173 injection; SHR-2173 injection；Low dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.	Week 24.

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 24-hour UPCR ;	up to Week 48
Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ;	up to Week 48
Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ;	up to Week 48
Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ;	up to Week 48
Change from baseline in 24-hour urinary protein quantification ;	up to Week 48
Change from baseline in estimated Glomerular Filtration Rate (eGFR) ;	up to Week 48
Change from baseline in hematuria ;	up to Week 48
Change from baseline in serum creatinine ;	up to Week 48
Proportion of participants achieving clinical remission;	up to Week 48
Annualized total eGFR slope from baseline ;	up to Week 48
Proportion of participants meeting composite endpoints ;	up to Week 48
Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ;	up to Week 48

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: SHR-2173-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No