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

Gout Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818085
• Other study ID #: ABP-671-301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 11, 2023
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
• Contact: Ullrich Schwertschlag, MD, PhD
• Phone: 978-257-1926
• Email: Ullrich.Schwertschlag[@]atombp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• ABP-671
Low, medium or high dose (Part 1); Selected dose(s) (Part 2)
• Allopurinol
Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout

Other:
• Placebo
ABP-671 matching placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Georgia,  Guatemala,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)		Week 28
Secondary	Incidence of treatment-emergent adverse events (Safety and Tolerability)	Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation	Week 28
Secondary	Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)		Week 28