GoutPhase 2/3NCT06276556
Extension Study of ABP-671 in Participants With Gout
A Phase 2/3 study testing ABP-671 and Allopurinol in people with Gout, run by Atom Therapeutics Co., Ltd at 54 sites in 5 countries.
Trial summary
The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3). Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gout
- What is being tested?
- ABP-671 and Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 54 sitesin 5 countries
- Study dates
- 22 Apr 2024to 5 Sep 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
United States33 sites
Anaheim Clinical Trials (Cenexel ACT)
Anaheim, California, 92801
Annapolis Internal Medicine/CCT Research
Annapolis, Maryland, 21401
Advanced Clinical Research of Atlanta
Atlanta, Georgia, 30309
Access Research Institute
Brooksville, Florida, 34613
PanAmerican Clinical Research, LLC
Brownsville, Texas, 78520
ClinSearch
Chattanooga, Tennessee, 37421
Centricity Research
Columbus, Georgia, 31904
Nature Coast Clinical Reasearch
Crystal River, Florida, 34429
JY Research Institute Inc.
Cutler Bay, Florida, 33189
Accel Clinical Research Site
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Medical Care/CCT
Elizabethton, Tennessee, 37643
DelRicht Research of Gulfport
Gulfport, Mississippi, 39501
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Santa Rosa Medical Center
Las Vegas, Nevada, 89119
A & D Doctor Center
Miami, Florida, 33135
Bioclinical Research Alliance
Miami, Florida, 33155
Cordova Research Institute
Miami, Florida, 33155
Century Research LLC
Miami, Florida, 33173
ITB Research
Miami, Florida, 33173
DelRicht Research
New Orleans, Louisiana, 70115
AMR
New Orleans, Louisiana, 70119
Alliance for Multispecialty Research, LLC.
Newton, Kansas, 67114
Quality Clinical Research, Inc
Omaha, Nebraska, 68114
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
New Horizons Research
Palmetto Bay, Florida, 33158
Center for Clinical Trials of Sacramento
Sacramento, California, 95823
OnSite Clinical Solutions
Salisbury, North Carolina, 28144
Quality Research Inc.
San Antonio, Texas, 78209
Worldwide Clinical Trials
San Antonio, Texas, 78217
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, 87505
Alliance for Multispecialty Research
Tempe, Arizona, 85281
Tucson Neuroscience Research, LLC
Tucson, Arizona, 85710
Australia6 sites
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148
Emeritus Research Sydney
Botany, New South Wales, 2019
Emeritus Research Melbourne
Camberwell, Victoria, 3124
Austin Health - Repatriation Hospital
Heidelberg, Victoria, 3084
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
A R Houston Medical Pty Ltd
Kippa-Ring, Queensland, 4021
Georgia6 sites
New Hospitals
Tbilisi, 0114
Evex Hospitals Caraps Medline
Tbilisi, 0159
Aversi Clini
Tbilisi, 0160
The First Medical Center
Tbilisi, 0180
Academician Vakhtang Bochorishvili Clinic
Tbilisi, 0186
Innova
Tbilisi, 0186
Taiwan5 sites
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, 62247
Chang Gung Memorial Hospital CGMH
Kaohsiung City, 833
Chung Shan Medical Univ. Hospital
Taichung, 402367
Cheng-Shin General Hospital
Taipei, 112401
Chang Gung Memorial Hospital LinKou
Taoyuan, 333423
Guatemala4 sites
Clinical Research Center (CRC)
Guatemala City, 01010
Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)
Guatemala City, 01010
Clínica Médica Especializada en Medicina Interna y Reumatología
Guatemala City, 01010
Clínica Médica Especializada en Medicina Interna
Guatemala City, 01010
About this study
Official 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
The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).
- Conditions
- Gout
- Being tested
- ABP-671, Allopurinol
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP-671Drug
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.
AllopurinolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ABP-671 | Experimental | Not described Receives: Drug: ABP-671 |
| Allopurinol | Active comparator | Not described Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Measured: Week 26
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
Measured: Week 26
Secondary outcomes (1)
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start22 Apr 2024
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Why it stopped: For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atom Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276556
- Sponsor's protocol ID
- ABP-671-302
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06276556
- Acronym / sponsor ID
- ABP-671-302
- Conditions
- Gout
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Atom Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABP-671 | Experimental | Drug: ABP-671 |
| Allopurinol | Active comparator | Drug: Allopurinol |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABP-671Participants 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. | Drug | ABP-671 |
| AllopurinolParticipants 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. | Drug | Allopurinol |
Primary outcome
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Time frame: Week 26
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Time frame: Week 26
Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation
1 secondary outcome
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
Time frame: Week 26
Results and safety
The study was stopped early (reason given: For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ABP-671 and Allopurinol in people with Gout, run by Atom Therapeutics Co., Ltd at 54 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Australia, Georgia, Taiwan, Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) (time frame: Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.