Clinical trial NCT05818085: Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout
Official title: A Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gout
Lead sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 580
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
timeFrame: Week 28
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (Safety and Tolerability)
timeFrame: Week 28
measure: Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
timeFrame: Week 28
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Alliance for Multispecialty Research
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research, LLC
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials (Cenexel ACT)
state: California
city: Sacramento
country: United States
facility: Center for Clinical Trials of Sacramento
state: California
city: Brooksville
country: United States
facility: Access Research Institute
state: Florida
city: Crystal River
country: United States
facility: Nature Coast Clinical Reasearch
state: Florida
city: Cutler Bay
country: United States
facility: JY Research Institute Inc.
state: Florida
city: DeLand
country: United States
facility: Accel Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Largo
country: United States
facility: Accel Research Sites Network - St. Pete-Largo Clinical Research Unit
state: Florida
city: Miami
country: United States
facility: A & D Doctor Center
state: Florida
city: Miami
country: United States
facility: Bioclinical Research Alliance
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: Century Research LLC
state: Florida
city: Miami
country: United States
facility: ITB Research
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Palmetto Bay
country: United States
facility: New Horizons Research
state: Florida
city: Atlanta
country: United States
facility: Advanced Clinical Research of Atlanta
state: Georgia
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC.
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: AMR
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine/CCT Research
state: Maryland
city: Gulfport
country: United States
facility: DelRicht Research of Gulfport
state: Mississippi
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Santa Rosa Medical Center
state: Nevada
city: Santa Fe
country: United States
facility: Inspire Santa Fe Medical Group
state: New Mexico
city: Salisbury
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Tulsa
country: United States
facility: DelRicht Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Elizabethton
country: United States
facility: Medical Care/CCT
state: Tennessee
city: Brownsville
country: United States
facility: PanAmerican Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: Suffolk
country: United States
facility: Centricity Research
state: Virginia
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Botany
country: Australia
facility: Emeritus Research Sydney
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
state: New South Wales
city: Kippa-Ring
country: Australia
facility: A R Houston Medical Pty Ltd
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health - Repatriation Hospital
state: Victoria
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: Evex Hospitals Caraps Medline
city: Tbilisi
country: Georgia
facility: Aversi Clini
city: Tbilisi
country: Georgia
facility: The First Medical Center
city: Tbilisi
country: Georgia
facility: Academician Vakhtang Bochorishvili Clinic
city: Tbilisi
country: Georgia
facility: Innova
city: Guatemala City
country: Guatemala
facility: Clinical Research Center (CRC)
city: Guatemala City
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)
city: Guatemala City
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna y Reumatología
city: Guatemala City
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna
city: Guatemala City
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna y Reumatología
city: Chiayi City
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital CGMH
city: Taichung
country: Taiwan
facility: Chung Shan Medical Univ. Hospital
city: Taipei City
country: Taiwan
facility: Cheng-Shin General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital LinKou
Study officials:
References: