Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

Study Purpose

This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male and female participants aged ≥19 and <70 years of age at the time of informed consent.

- A body mass index (BMI) of ≥18 kg/m2 to ≤40 kg/m2.

- Diagnosis of gout per American College of Rheumatology/European Alliance of Associations for Rheumatology 2015 Gout Classification Criteria and must meet the criteria as follows: - At Screening, participants with gout on ULT (including allopurinol) must be willing to discontinue ULT.

- At Screening, participants with gout who are not currently treated with any UA lowering therapy must have an sUA ≥7.5 mg/dL (≥0.450 mmol/L).

- At the confirmatory sUA visit, all participants must have an sUA ≥7.0 mg/dL (≥0.420 mmol/L).

- Women of childbearing potential (WOCBP) must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or willing to use acceptable and highly effective double contraception from Screening until at least 30 days after the last dose of the study drug.

Double contraception is defined as a condom AND one other form of the following:

- Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones); - A vaginal ring or an intrauterine device OR.

- Documented evidence of surgical sterilization at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is the sole partner).

The absence of records will not exclude screening the participant; if medical records cannot be obtained, serum pregnancy testing will be conducted to confirm the participant is not pregnant. Note: Women not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through follicle stimulating hormone (FSH) concentration testing. -Men must be surgically sterile (>30 days since vasectomy), abstinent, or if engaged in sexual relations with a female partner of childbearing potential, the participant must use an acceptable form of contraception from Screening until at least 30 days after the last dose of the study drug. Acceptable methods of contraception include the use of condoms in addition to the use of an effective contraceptive for the female partner that includes approved oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device. Participants who practice abstinence (abstinence from penile-vaginal intercourse) are eligible when this is in line with their preferred and usual lifestyle. In addition, men must not donate sperm for at least 30 days after the last dose of the study drug.

Exclusion Criteria:

- History of rheumatoid arthritis or other autoimmune disease.

- Clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder.

- Positive test result for HIV, hepatitis B surface antigen, or hepatitis C virus antibody.

Active hepatitis C virus infection is defined as a participant with a positive hepatitis C antibody and detectable hepatitis C viral load RNA.

- Participants who, in the opinion of the Investigator, have a high genetic risk of allopurinol hypersensitivity syndrome unless they have been found to be negative for Human leukocyte antigen (HLA)-B*5801, either clinically by prior exposure to allopurinol or by laboratory evaluation.

- Liver function tests >2x the laboratory upper limit of normal (ULN) range of aspartate aminotransferase, alkaline phosphatase, or alanine aminotransferase; total bilirubin >1.5x ULN at Screening.

- Inadequate renal function with serum creatinine >1.5 mg/dL (>0.133 mmol/L) or estimated glomerular filtration rate (eGFR) < 60 mL/min/m2 (by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-based eGFR equation).

- History of malignancy within the previous 5 years; with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ grade 1 cervical cancer.

- History within the last 12 months of unstable angina, New York Heart Association functional class III or IV heart failure, myocardial infarction, stroke, venous thromboembolism, or a history of percutaneous coronary intervention.

- Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥90 mmHg).

If BP is controlled while taking antihypertensive medication, the participant must be on stable dose for previous 2 months.

- Active liver disease or impaired hepatic function as assessed by liver function tests.

- Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening.

- Any other medical or psychological condition, that, in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the study, or potentially compromise the results or interpretation of the study.

- Pregnant, breastfeeding, or planning a pregnancy during the study or ≤30 days after the last dose of the study drug.

- Intolerant or unwilling to take colchicine or naproxen.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05818085
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Georgia, Guatemala, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gout

Arms & Interventions

Arms

Experimental: ABP-671

Active Comparator: Allopurinol

Placebo Comparator: Placebo

Interventions

Drug: - ABP-671

Low, medium or high dose (Part 1); Selected dose(s) (Part 2)

Drug: - Allopurinol

Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout

Other: - Placebo

ABP-671 matching placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Alliance for Multispecialty Research, Tempe, Arizona

Status

Recruiting

Address

Alliance for Multispecialty Research

Tempe, Arizona, 85281

Site Contact

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