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 range18 Years – 75 Years
SexALL
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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…