Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia (NCT07498647) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia
160 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Only those subjects who meet all the following inclusion criteria are eligible to participate in this study:
* 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
Exclusion Criteria:
* 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 n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.