Clinical Study of HRS-2129 for Acute Gouty Arthritis

Clinical Study on Safety and Efficacy of HRS-2129 for Acute Gouty Arthritis

The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for acute gouty arthritis. To explore the reasonable dosage of HRS-2129 for acute gouty arthritis.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Gouty Arthritis
• Intervention / Treatment: Drug: HRS-2129 Tablet; Drug: HRS-2129 Tablet; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lei Tang; Phone Number: +0518-82342973; Email: lei.tang.lt31@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital of Sun Yat-sen University
      • Principal Investigator: Yunfeng Pan
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
      • Principal Investigator: Lingyun Sun

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring Acute gouty arthritis
3. Target joint VAS pain score ≥ 50 mm (screening)

Exclusion Criteria:

1. Subjects with a history of severe allergies
2. Subjects with nervous system disease
3. Subjects with a history of mental illness
4. Subjects with abnormal liver and renal function
5. Subjects with poorly controlled hypertensive
6. QTc：>450ms（male），>470ms（female）
7. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-2129 Tablet	Drug: HRS-2129 Tablet; HRS-2129 Tablet; high dose; Drug: HRS-2129 Tablet; HRS-2129 Tablet; low dose
Experimental: Treatment group B: HRS-2129 Tablet	Drug: HRS-2129 Tablet; HRS-2129 Tablet; high dose; Drug: HRS-2129 Tablet; HRS-2129 Tablet; low dose
Placebo Comparator: Treatment group C: HRS-2129 Tablet Placebo	Drug: Placebo; HRS-2129 Tablet Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose	VAS，Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)	from ICF signing date to 24 hours after first dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in VAS pain score at 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours post first dose	from ICF signing date to 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours after first dose
Time until complete disappearance of pain in the target joint	from ICF signing date to 15 days after first dose
Mean daily VAS pain score change from baseline (on-treatment)	from ICF signing date to 15 days after first dose
Safety：Incidence and severity of AE/SAE	from ICF signing date to day 14 after last dose(14 days)

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HRS-2129-207

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