A Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout

ClinicalTrials.gov processed this data on September 11, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified August 2024 by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Sponsor

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Information Provided by (Responsible Party)

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Clinicaltrials.gov Identifier

NCT05818085
Other Study ID Numbers: ABP-671-301
First Submitted: April 5, 2023
First Posted: April 18, 2023
Last Update Posted: September 19, 2024
Last Verified: August 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Gout
  • Drug: ABP-671
  • Drug: Allopurinol
  • Other: Placebo

Study Design

Study TypeInterventional
Anticipated Enrollment580 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout
Study Start DateAugust 11, 2023
Anticipated Primary Completion DateAugust 2025
Anticipated Study Completion DateAugust 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • ABP-671
  • Drug: ABP-671
    • Low, medium or high dose (Part 1); Selected dose(s) (Part 2)
  • Allopurinol
  • Drug: Allopurinol
    • Placebo
    • Other: Placebo

      Outcome Measures

      Primary Outcome Measures

      1. Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) [Week 28]

      Secondary Outcome Measures

      1. Incidence of treatment-emergent adverse events (Safety and Tolerability) [Week 28]
        Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation
      2. Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) [Week 28]

      Eligibility Criteria

      Ages Eligible for Study 19 Years to 75 Years (Adult, Older Adult)
      Sexes Eligible for Study All
      Accepts Healthy Volunteers No
      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.

      Contacts and Locations

      Sponsors and Collaborators Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
      Locations
      • Alliance for Multispecialty Research | Tempe, Arizona, United States, 85281
      • Tucson Neuroscience Research, LLC | Tucson, Arizona, United States, 85710
      • Anaheim Clinical Trials (Cenexel ACT) | Anaheim, California, United States, 92801
      • Center for Clinical Trials of Sacramento | Sacramento, California, United States, 95823
      • Access Research Institute | Brooksville, Florida, United States, 34613
      • Nature Coast Clinical Reasearch | Crystal River, Florida, United States, 34429
      • JY Research Institute Inc. | Cutler Bay, Florida, United States, 33189
      • Accel Clinical Research Site | DeLand, Florida, United States, 32720
      • Jacksonville Center for Clinical Research | Jacksonville, Florida, United States, 32216
      • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit | Largo, Florida, United States, 33777
      • A & D Doctor Center | Miami, Florida, United States, 33135
      • Bioclinical Research Alliance | Miami, Florida, United States, 33155
      • Cordova Research Institute | Miami, Florida, United States, 33155
      • Century Research LLC | Miami, Florida, United States, 33173
      • ITB Research | Miami, Florida, United States, 33173
      • Combined Research Orlando Phase I-IV | Orlando, Florida, United States, 32807
      • New Horizons Research | Palmetto Bay, Florida, United States, 33158
      • Advanced Clinical Research of Atlanta | Atlanta, Georgia, United States, 30309
      • Centricity Research | Columbus, Georgia, United States, 31904
      • Alliance for Multispecialty Research, LLC. | Newton, Kansas, United States, 67114
      • DelRicht Research | New Orleans, Louisiana, United States, 70115
      • AMR | New Orleans, Louisiana, United States, 70119
      • Annapolis Internal Medicine/CCT Research | Annapolis, Maryland, United States, 21401
      • DelRicht Research of Gulfport | Gulfport, Mississippi, United States, 39501
      • Quality Clinical Research, Inc | Omaha, Nebraska, United States, 68114
      • Santa Rosa Medical Center | Las Vegas, Nevada, United States, 89119
      • Inspire Santa Fe Medical Group | Santa Fe, New Mexico, United States, 87505
      • OnSite Clinical Solutions | Salisbury, North Carolina, United States, 28144
      • DelRicht Research | Tulsa, Oklahoma, United States, 74133
      • Altoona Center for Clinical Research | Duncansville, Pennsylvania, United States, 16635
      • ClinSearch | Chattanooga, Tennessee, United States, 37421
      • Medical Care/CCT | Elizabethton, Tennessee, United States, 37643
      • PanAmerican Clinical Research, LLC | Brownsville, Texas, United States, 78520
      • Quality Research Inc. | San Antonio, Texas, United States, 78209
      • Centricity Research | Suffolk, Virginia, United States, 23435
      • Paratus Clinical Research Western Sydney | Blacktown, New South Wales, Australia, 2148
      • Emeritus Research Sydney | Botany, New South Wales, Australia, 2019
      • Paratus Clinical Research Central Coast | Kanwal, New South Wales, Australia, 2259
      • A R Houston Medical Pty Ltd | Kippa-Ring, Queensland, Australia, 4021
      • Emeritus Research Melbourne | Camberwell, Victoria, Australia, 3124
      • Austin Health - Repatriation Hospital | Heidelberg, Victoria, Australia, 3084
      • New Hospitals | Tbilisi, Georgia, 0114
      • Evex Hospitals Caraps Medline | Tbilisi, Georgia, 0159
      • Aversi Clini | Tbilisi, Georgia, 0160
      • The First Medical Center | Tbilisi, Georgia, 0180
      • Academician Vakhtang Bochorishvili Clinic | Tbilisi, Georgia, 0186
      • Innova | Tbilisi, Georgia, 0186
      • Clinical Research Center (CRC) | Guatemala City, Guatemala, 01010
      • Clínica Médica Especializada en Medicina Interna y Reumatología (CREER) | Guatemala City, Guatemala, 01010
      • Clínica Médica Especializada en Medicina Interna y Reumatología | Guatemala City, Guatemala, 01010
      • Clínica Médica Especializada en Medicina Interna | Guatemala City, Guatemala, 01010
      • Clínica Médica Especializada en Medicina Interna y Reumatología | Guatemala City, Guatemala, 1011
      • Buddhist Dalin Tzu Chi General Hospital | Chiayi City, Taiwan, 62247
      • Chang Gung Memorial Hospital CGMH | Kaohsiung City, Taiwan, 833
      • Chung Shan Medical Univ. Hospital | Taichung, Taiwan, 402367
      • Cheng-Shin General Hospital | Taipei City, Taiwan, 112401
      • Chang Gung Memorial Hospital LinKou | Taoyuan, Taiwan, 333423

      More Information

      Additional Relevant MeSH Terms

      • Gout
      • Arthritis
      • Joint Diseases
      • Musculoskeletal Diseases
      • Crystal Arthropathies
      • Rheumatic Diseases
      • Purine-Pyrimidine Metabolism, Inborn Errors
      • Metabolism, Inborn Errors
      • Genetic Diseases, Inborn
      • Metabolic Diseases