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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05818085




Registration number
NCT05818085
Ethics application status
Date submitted
5/04/2023
Date registered
18/04/2023

Titles & IDs
Public title
Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout
Scientific title
A Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout
Secondary ID [1] 0 0
ABP-671-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABP-671
Treatment: Drugs - Allopurinol
Other interventions - Placebo

Experimental: ABP-671 -

Active comparator: Allopurinol -

Placebo comparator: Placebo -


Treatment: Drugs: ABP-671
Low, medium or high dose (Part 1); Selected dose(s) (Part 2)

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

Other interventions: Placebo
ABP-671 matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Timepoint [1] 0 0
Week 28
Secondary outcome [1] 0 0
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Timepoint [1] 0 0
Week 28
Secondary outcome [2] 0 0
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
Timepoint [2] 0 0
Week 28

Eligibility
Key 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.
Minimum age
19 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
580
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Emeritus Research Sydney - Botany
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [4] 0 0
A R Houston Medical Pty Ltd - Kippa-Ring
Recruitment hospital [5] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment hospital [6] 0 0
Austin Health - Repatriation Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Georgia
State/province [18] 0 0
Tbilisi
Country [19] 0 0
Guatemala
State/province [19] 0 0
Guatemala City
Country [20] 0 0
Taiwan
State/province [20] 0 0
Chiayi City
Country [21] 0 0
Taiwan
State/province [21] 0 0
Kaohsiung City
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taichung
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taipei City
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ullrich Schwertschlag, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
978-257-1926
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05818085