ABP-671 for Gout

No longer recruiting at 62 trial locations

Overseen By Ullrich Schwertschlag, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Atom Therapeutics Co., Ltd

Must not be taking: Colchicine, Naproxen

Disqualifiers: Rheumatoid arthritis, Autoimmune, Hepatic, Cardiovascular, Renal, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of a new treatment, ABP-671, for managing gout. Gout causes painful joint inflammation due to high uric acid levels in the blood. The trial will compare different doses of ABP-671 with a placebo (a non-active substance) and a common gout medication, allopurinol, to determine which works best. Individuals diagnosed with gout and high uric acid levels may be suitable candidates for this trial. As a Phase 2 trial, this research measures how well ABP-671 works in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

If you are currently taking urate-lowering therapy (ULT) like allopurinol for gout, you will need to stop taking it to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that ABP-671 has promising safety results. Patients who took ABP-671 experienced fewer gout attacks than those taking allopurinol or a placebo, suggesting that ABP-671 is well-tolerated.

Allopurinol, already approved by the FDA for treating gout, has a well-known safety record. It is generally safe but can sometimes cause side effects like diarrhea. Rarely, more serious reactions occur.

Both treatments have been tested in people, and their safety records are well-documented. This information can reassure those considering joining a clinical trial about the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABP-671 for gout because it offers a fresh approach compared to traditional treatments like Allopurinol. Most gout treatments focus on reducing uric acid levels through inhibition of xanthine oxidase, but ABP-671 works differently, potentially targeting a novel pathway to lower uric acid production more effectively. This unique mechanism could offer better control of gout symptoms with possibly fewer side effects, making it an exciting prospect for those who struggle with current medications.

What evidence suggests that this trial's treatments could be effective for gout?

Research has shown that ABP-671, one of the treatments in this trial, may help reduce gout attacks. In previous studies, participants taking ABP-671 experienced fewer gout attacks than those taking allopurinol or a placebo. Higher doses of ABP-671 also helped many participants lower their blood uric acid levels, which is important for managing gout. Most participants tolerated ABP-671 well, with no major safety issues reported. Allopurinol, another treatment option in this trial, is a well-known gout treatment that effectively lowers uric acid levels and controls flare-ups. However, some individuals find it challenging to adhere to their allopurinol treatment plan. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 19-69 with gout, as defined by specific criteria, and a certain level of uric acid in their blood can join. They must not be on uric acid-lowering therapy or agree to stop it. Women who can have children must use reliable birth control, and men too if they're with partners who can get pregnant.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 40.

You have been diagnosed with gout according to specific guidelines from rheumatology organizations.

I am a man who is either surgically sterile, not sexually active, or using contraception if my partner can bear children.

Exclusion Criteria

Pregnant, breastfeeding, or planning a pregnancy during the study or ≤30 days after the last dose of the study drug

I have a history of rheumatoid arthritis or another autoimmune disease.

Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Comparison of different doses and regimens of ABP-671 with placebo and allopurinol

28 weeks

Treatment Part 2

Comparison of selected dosing regimen(s) of ABP-671 from Part 1 with placebo

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABP-671
• Allopurinol
• Placebo

Trial Overview

The trial is testing ABP-671, a new drug for gout against a placebo and allopurinol (a standard treatment). It's done in two parts: first comparing different doses of ABP-671 to the others, then the best dose from part one against placebo alone.

How Is the Trial Designed?

Group I: ABP-671 Experimental Treatment 1 Intervention

Group II: Allopurinol Active Control 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Atom Therapeutics Co., Ltd

Lead Sponsor

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

7

Recruited

880+

Published Research Related to This Trial

A 56-year-old man experienced a return of acute gout symptoms after switching from the brand formulation of allopurinol (Zyloric®) to a generic version, indicating a lack of therapeutic effect from the generic.

Upon reverting to the brand formulation, the patient's symptoms improved, suggesting that not all generic medications may provide the same efficacy as their brand-name counterparts, highlighting the need for more data on the effectiveness of generic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of efficacy during the switch from brand to generic allopurinol. De Vuono, A., Scicchitano, F., Palleria, C., et al.[2013]

Febuxostat is associated with a higher risk of cardiovascular adverse events, including heart failure and ischemic heart disease, particularly in elderly gout patients, compared to allopurinol.

The analysis of 64 quarters of data from the FDA Adverse Event Reporting System revealed that febuxostat had 2,939 reports of cardiovascular adverse events, while allopurinol had 25,219, indicating a significant concern for febuxostat's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Safety Evaluation of Febuxostat and Allopurinol: Findings from the FDA Adverse Event Reporting System. Bai, Y., Wu, B., Gou, L., et al.[2023]

The management of gout involves three key stages: treating acute attacks, lowering uric acid levels to prevent future flares, and providing prophylaxis against acute attacks, with NSAIDs being the preferred treatment for acute inflammation if started early.

For chronic gout management, xanthine oxidase inhibitors like allopurinol are recommended as first-line treatments, especially for patients with renal issues or those on diuretics, while uricosuric drugs are suitable for patients allergic to allopurinol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of acute and chronic gouty arthritis: present state-of-the-art. Schlesinger, N.[2018]

In a study of 96 gout patients, allopurinol at 300 mg/day showed limited efficacy, with only 24% reaching the target serum urate level after 2 months, and 11% discontinuing due to side effects.

When patients switched to second-line treatments, benzbromarone (200 mg/day) was significantly more effective than probenecid (2 g/day), achieving a 92% success rate in lowering serum urate compared to 65% for probenecid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of urate-lowering drugs in gout: a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol. Reinders, MK., van Roon, EN., Jansen, TL., et al.[2022]

A review of 901 cases of allopurinol hypersensitivity (AH) revealed that risk factors such as renal impairment, hypertension, and the presence of the HLA-B*5801 allele are commonly associated with this serious adverse reaction, particularly in Asian populations.

The study found no significant link between higher doses of allopurinol and an increased risk of severe cutaneous reactions, challenging previous assumptions about dosage as a risk factor for AH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allopurinol hypersensitivity: a systematic review of all published cases, 1950-2012. Ramasamy, SN., Korb-Wells, CS., Kannangara, DR., et al.[2022]

Citations

1.

atomthera.us

atomthera.us/2025/09/07/atom-announces-positive-topline-results-of-lingdolinurad-in-phase-2b-3-trial-for-gout/

Atom Therapeutics Announces Positive Topline Results of ...

Compared to the allopurinol group and placebo group, ABP-671 significantly reduced the relative risk of acute gout attacks with a maximum risk ...

2.

biospace.com

biospace.com/press-releases/atom-therapeutics-announces-positive-topline-results-of-lingdolinurad-abp-671-in-phase-2b-3-trial-for-chronic-gout

Atom Therapeutics Announces Positive Topline Results of ...

Compared to the allopurinol group and placebo group, ABP-671 significantly reduced the relative risk of acute gout attacks with a maximum risk ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05818085

NCT05818085 | Phase 2b/3 Study to Assess ABP-671 a ...

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 ...

4.

firstwordpharma.com

firstwordpharma.com/story/6327776

Atom Therapeutics to Present Positive Data from Clinical ...

Higher doses of ABP-671 reduced sUA levels to below 4mg/dL in many patients. ABP-671 was generally safe and well-tolerated. Based on these study ...

5.

acrabstracts.org

acrabstracts.org/abstract/a-double-blind-placebo-controlled-ascending-dose-phase-2a-study-of-abp-671-a-novel-potent-and-selective-urat1-inhibitor-in-patients-with-gout-or-hyperuricemia/

A Double-Blind, Placebo-Controlled, Ascending Dose ...

At the end of the respective dose evaluation periods, an average of 87% of the ABP-671 participants attained target sUA level of < 6 mg/dL, compared to 0% of ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04638543

NCT04638543 | A Study to Assess the Efficacy, Safety, and ...

The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD ...

7.

fiercebiotech.com

fiercebiotech.com/biotech/atom-claims-phase-3-win-shows-gout-drug-can-beat-competition-efficacy-safety

Atom claims phase 3 win shows gout drug can beat ...

When compared to the allopurinol and placebo cohorts, patients who received ABP-671 experienced a significant reduction in the relative risk of ...

8.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/atom-bioscience-abp-671/

Atom Bioscience doses patients in chronic gout therapy trial

Among patients given 1mg of ABP-671 once a day, 86% reached serum uric acid (sUA) levels of less than 6mg/dL. Email newsletter icon. Sign up for ...