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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06276556




Registration number
NCT06276556
Ethics application status
Date submitted
12/02/2024
Date registered
26/02/2024

Titles & IDs
Public title
Extension Study of ABP-671 in Participants With Gout
Scientific title
A Multicenter, Double-blind, Phase 2b/3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301
Secondary ID [1] 0 0
ABP-671-302
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

Experimental: ABP-671 -

Active comparator: Allopurinol -


Treatment: Drugs: ABP-671
Participants who were randomized to any of the ABP-671 treatment groups in Part 1 or Part 2 of Study ABP-671-301 will continue to receive the same dose level and dosing regimen during the Treatment Period of this Extension Study.

Participants who were randomized to receive placebo in Part 1 or Part 2 of Study ABP-671-301 will receive ABP-671 during the Treatment Period of the Extension Study.

Treatment: Drugs: Allopurinol
Participants who were randomized to receive allopurinol in Part 1 of Study ABP-671-301 will continue to receive allopurinol during the Treatment Period of the Extension Study.
Intervention code [1] 0 0
Treatment: Drugs
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 26
Primary outcome [2] 0 0
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Timepoint [2] 0 0
Week 26
Secondary outcome [1] 0 0
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
Timepoint [1] 0 0
Week 26

Eligibility
Key inclusion criteria
* Must have completed the double-blind Treatment Period in Study ABP-671-301 (Part 1 or Part 2) and are actively receiving and tolerating the study drug up to the Week 28 visit in Study ABP-671-301
Minimum age
19 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a new 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 Extension Study, or potentially compromise the results or interpretation of the Extension Study.
* Is planning to become pregnant or breastfeed during the study or within =30 days after the last dose of the study drug.
* Is 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/07/2025
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
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Georgia
State/province [16] 0 0
Tbilisi
Country [17] 0 0
Guatemala
State/province [17] 0 0
Guatemala city
Country [18] 0 0
Taiwan
State/province [18] 0 0
Chiayi City
Country [19] 0 0
Taiwan
State/province [19] 0 0
Kaohsiung City
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taichung
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taipei City
Country [22] 0 0
Taiwan
State/province [22] 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT06276556