Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN

A Randomized, Double-blind, and Placebo-controlled Parallel Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

Study Overview

• Status: Completed
• Conditions: IgA Nephropathy (IgAN)
• Intervention / Treatment: Drug: Placebo; Drug: HSK39297 50mgBID; Drug: HSK39297 100mgBID; Drug: HSK39297 200mgQD

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
2. Female and male patients above 18 years of age.
3. Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2
4. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior five years.
5. Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.

Exclusion Criteria:

1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
2. All transplanted patients (any organ, including bone marrow).
3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
5. Pregnant or nursing (lactating) women.
6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; QD or BID, 24-weeks fixed dose.
Experimental: HSK39297 50mg BID	Drug: HSK39297 50mgBID; 24-weeks fixed dose.
Experimental: HSK39297 100mg BID	Drug: HSK39297 100mgBID; 24-weeks fixed dose.
Experimental: HSK39297 200mg QD	Drug: HSK39297 200mgQD; 24-weeks fixed dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment	From week 1 to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 24 weeks of treatment		From week 1 to week 24
The ratio of 24h-UPCR compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24
The ratio of 24-hour urine protein (24h-UPE) compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24
The change in estimated glomerular filtration rate (eGFR, CKD-EPI 2021 formula) compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24
The change in blood creatinine compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24
The ratio of FMV UPCR, urinary albumin to creatinine ratio (UACR) compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24
The change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale score compared to baseline at each clinical visit point during the treatment period	0-52, the higher the score, the better the QOL.	From week 1 to week 24
Incidence , severity and relationship of adverse events during the study period		From week 1 to week 24
Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) of HSK39297		From week 1 to week 24
Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) of HSK39297		From week 1 to week 24
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297		From week 1 to week 24
Plasma Pharmacokinetics (PK) of Maximum Concentrations (Cmax,ss) at Steady State of HSK39297		From week 1 to week 24
Changes in alternative pathway (AP) complement activity compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24
Changes in plasma Bb levels compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24
Changes in plasma and urine sC5b-9 levels compared to baseline at each clinical visit point during the treatment period		From week 1 to week 24

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Actual): December 20, 2025
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 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: HSK39297-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No