Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia

NCT07498647 | Not Yet Recruiting Phase 2

• 1 other identifier: BR2251-201
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia. This study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (12 weeks), and a follow-up period (2 weeks). The screened subjects were stratified based on whether their serum uric acid (sUA) was less than 480 μmol/L or greater than or equal to 480 μmol/L. They were randomly assigned to 4 treatment groups in a 1:1:1:1 ratio: the test drug group 1 (low-dose group), the test drug group 2 (medium-dose group), the test drug group 3 (high-dose group), and the control group (non-befloxacin tablets 40 mg), with 40 subjects in each group. Each group will use titration dosing.

Conditions

Gout and Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• Uric acid

  serum uric acid levels at various time points

  Treated to 12 weeks

Secondary Outcomes (3)

• Uric acid

  Treated to 12 weeks

• Uric acid

  at the 2nd, 4th, 6th, 8th and 10th weeks of treatment

• The proportion and frequency of patients with acute gout who require treatment

  12-week treatment period

Study Arms (4)

BR2251 low dose

EXPERIMENTAL

BR2251 (Experimental drug) low dose

Drug: BR2251

BR2251 mid dose

EXPERIMENTAL

BR2251 (Experimental drug) mid dose

Drug: BR2251

BR2251 high dose

EXPERIMENTAL

BR2251 (Experimental drug) high dose

Drug: BR2251

Febuxostat

ACTIVE COMPARATOR

Febuxostat(40mg)

Drug: Febuxostat

Interventions

BR2251 DRUG

BR2251 low dose, mid dose, high dose, Titration regimen and Take orally once a day

BR2251 high dose; BR2251 low dose; BR2251 mid dose

Febuxostat DRUG

Febuxostat(40mg) Titration regimen and Take orally once a day

Febuxostat

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in this trial and signing of the informed consent form, and those who can complete the trial according to the protocol;
• Age between 18 and 75 years old (inclusive of the boundary value, based on the date of signing the informed consent form), regardless of gender;
• Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2;
• Meeting the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria, and serum uric acid (sUA) ≥ 420 μmol/L during the screening period;
• Women of reproductive age with negative pregnancy test during the screening period and before the first administration of the investigational drug (D1 \[allowing a time window of -7 days\]), and both female and male subjects of reproductive age must agree to voluntarily take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration of the drug

You may not qualify if:

• Those who are known or suspected to be allergic to the test drug or its components, or who have previously been intolerant to febuxostat or have contraindications.
• Subjects with secondary gout accompanied by hyperuricemia caused by other diseases or medications.
• Those who have had acute gout attacks within the previous 2 weeks.
• Those who have been diagnosed with uric acid nephropathy in the past or have imaging or clinical manifestations of urinary system stones (such as hematuria, back pain) within the previous 2 weeks.
• Those with other joint lesions that the investigator considers may confuse gouty arthritis, such as rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, systemic lupus erythematosus, or joint lesions caused by chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive nephropathy, etc.
• Those with any disease or surgical history that the investigator judges may affect the PK characteristics of the drug, such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease, digestive organ resection, kidney resection, etc.
• Those who have used any organic anion transporter 1 and 3 (OAT1\&3) substrate drugs within the previous 2 weeks.
• Those who have used any other uric acid-lowering drugs within the previous 2 weeks and have other concomitant medications that affect uric acid levels (including but not limited to losartan, calcium channel blockers, fenofibrate, atorvastatin calcium, alpha-glucosidase inhibitor, insulin sensitizers, DPP4 inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, metformin) using a stable dose.
• Those who have used aspirin within the previous 2 weeks.
• Those who have used any diuretic within the previous 2 weeks.
• Those with diseases that require long-term use of drugs metabolized by xanthine oxidase, including but not limited to azathioprine, mercaptopurine, etc.
• Any abnormal laboratory test results at screening: a. Abnormal liver function, defined as AST or ALT values \> 2× the upper limit of normal (ULN), or TBIL \> 1.5× ULN; b. WBC \< 3.0×109/L, PLT \< 75×109/L, or HB \< 90 g/L; c. Scr \> 1.5× ULN, or estimated eGFR \< 60 mL/min/1.73 m2 using the CKD-EPI formula; d. CK \> 1.5× ULN.
• Viral test results at screening: a. Those with positive hepatitis B surface antigen (HBsAg) and HBV-DNA \> 1000 IU/mL; b. Those with positive HCV antibody and positive HCV-RNA; d. Those with positive HIV serum reaction; e. Those with positive syphilis antibody and requiring treatment after consultation with the infectious disease department.
• Other serious diseases that may limit the participation of the subjects in this trial, such as: uncontrolled diabetes (glycated hemoglobin \> 8.4% as assessed by the investigator); severe heart failure (NYHA class II or above); acute coronary syndrome, acute cerebrovascular accident within the past 6 months; coronary revascularization such as stent implantation, coronary artery bypass surgery, and other heart and large vessel-related surgeries within the past 6 months; severe arrhythmia within the past 6 months including frequent premature ventricular contractions, ventricular tachycardia, atrial fibrillation/atrial flutter, severe bradycardia; uncontrolled hypertension (greater than 160/100 mmHg); severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm) etc.
• Electrocardiogram at screening showing prolonged QTcF interval (Fridericia formula) (males \> 450 ms, females \> 470 ms).

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaofeng Zeng, Doctor

CONTACT

+8613501069845; xiaofeng.zeng@cstar.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share