What side effects are associated with this type of intervention?

Common treatments for gout include NSAIDs, colchicine, corticosteroids, allopurinol, and febuxostat. NSAIDs may cause gastrointestinal issues, cardiovascular risks, and renal impairment. Colchicine often leads to gastrointestinal disturbances such as diarrhea and nausea. Corticosteroids can result in weight gain, hypertension, and increased infection risk. Allopurinol is associated with skin rashes and rare severe hypersensitivity reactions. Febuxostat has been linked to liver function abnormalities and a higher risk of cardiovascular events compared to allopurinol. These side effects should be considered when evaluating new treatments like ABP-671.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of gout, focusing on different mechanisms to manage uric acid levels. Allopurinol, a xanthine oxidase inhibitor (XOI), was one of the first approved and remains widely used. Febuxostat, another XOI, offers an alternative for patients who do not tolerate allopurinol, though it carries a boxed warning for cardiovascular risks. Pegloticase, an enzyme that breaks down uric acid, is used for refractory gout cases. Uricosuric agents like probenecid increase uric acid excretion. The novel URAT1 inhibitor ABP-671, currently under study, is similar to these uricosuric agents, aiming to enhance uric acid excretion through a different pathway.

What other types of research exist?

Promising novel alternatives to ABP-671 for gout patients include febuxostat (a urate synthesis inhibitor), lesinurad (a URAT-1 inhibitor), and IL-1β antagonists such as canakinumab, rilonacept, and anakinra. These therapies offer different mechanisms of action and have shown efficacy in reducing serum uric acid levels and managing gout symptoms.

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URAT1 Inhibitor

ABP-671 for Gout

Q: What is the mechanism of action of this treatment?

Gout treatments primarily target the reduction of uric acid levels in the blood to prevent crystal formation and inflammation. Xanthine oxidase inhibitors, such as allopurinol and febuxostat, reduce uric acid production by inhibiting the enzyme xanthine oxidase. Uricosuric agents, like probenecid, increase the excretion of uric acid by the kidneys. Uricolytic enzymes, such as pegloticase, break down uric acid into more soluble compounds. These mechanisms are crucial for gout patients as they help to lower serum urate levels, reduce the frequency of gout flares, and prevent long-term joint damage. Novel agents like ABP-671, likely a urate transporter inhibitor, represent an emerging class that may offer additional options for patients who do not respond adequately to existing therapies.

Phase 2 & 3

Recruiting

Research Sponsored by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female participants aged ≥19 and <70 years of age at the time of informed consent

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 28

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of ABP-671 versus placebo and allopurinol to treat gout. It consists of two parts, assessing different doses and regimens.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects aren't specified here but could include reactions similar to other medications for gout such as stomach pain, rash, kidney issues or liver problems. The study will monitor participants closely for any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19 and 70 years old.

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I have gout and my uric acid level is 7.5 mg/dL or higher.

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I am a woman who has been postmenopausal for at least 12 months.

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I am willing to stop my gout medication for the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)

Secondary outcome measures

Incidence of treatment-emergent adverse events (Safety and Tolerability)

Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)

Side effects data

From 2019 Phase 3 trial • 530 Patients • NCT02017171

16%

Rash

12%

Upper respiratory tract infection

10%

Hypoglycaemia

Nasopharyngitis

Influenza like illness

Urinary tract infection

Sinusitis

Diabetic ketoacidosis

Pain in extremity

Bronchitis

Acute myocardial infarction

Osteomyelitis

Abortion spontaneous

Diarrhoea

Myocardial infarction

Cardiac failure congestive

Diabetic gastroparesis

Chest pain

Pancreatitis acute

Asthma

Coronary artery disease

Gastrointestinal haemorrhage

Pneumonia

Cardiac arrest

Hyperglycaemia

Death

Cellulitis

Staphylococcal infection

Road traffic accident

Renal failure acute

Pregnancy

Skin ulcer

Amputation

Hyperemesis gravidarum

Angina unstable

Impaired gastric emptying

Cerebrovascular accident

100%

80%

60%

40%

20%

Study treatment Arm

Allopurinol

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ABP-671Experimental Treatment1 Intervention

Group II: AllopurinolActive Control1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABP-671

2020

Completed Phase 2

~140

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Gout treatments primarily target the reduction of uric acid levels in the blood to prevent crystal formation and inflammation. Xanthine oxidase inhibitors, such as allopurinol and febuxostat, reduce uric acid production by inhibiting the enzyme xanthine oxidase. Uricosuric agents, like probenecid, increase the excretion of uric acid by the kidneys. Uricolytic enzymes, such as pegloticase, break down uric acid into more soluble compounds. These mechanisms are crucial for gout patients as they help to lower serum urate levels, reduce the frequency of gout flares, and prevent long-term joint damage. Novel agents like ABP-671, likely a urate transporter inhibitor, represent an emerging class that may offer additional options for patients who do not respond adequately to existing therapies.

Uric acid lowering for slowing CKD progression after the CKD-FIX trial: a solved question or still a dilemma?Management of Hyperuricemia in Patients with Chronic Kidney Disease: a Focus on Renal Protection.Recent approaches to gout drug discovery: an update.

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Who is running the clinical trial?

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

6 Previous Clinical Trials

837 Total Patients Enrolled

6 Trials studying Gout

837 Patients Enrolled for Gout

~105 spots leftby Aug 2024

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