ABP-671 for Gout

Recruiting at 59 trial locations

Overseen By Ullrich Schwertschlag, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Jiangsu Atom Bioscience and Pharmaceutical 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

580 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called ABP-671 to see if it works better than an existing drug, allopurinol. Allopurinol has been used since 1966 to reduce urate production. The trial focuses on people who might not respond well to current treatments. ABP-671 probably helps reduce uric acid levels in the body.

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.

What data supports the effectiveness of the drug ABP-671 for gout?

The research highlights that allopurinol, a component of ABP-671, is effective as a first-line treatment for lowering uric acid levels in gout patients, which helps prevent gout flares. Additionally, urate-lowering therapy, including allopurinol, is recommended for long-term management of gout to reduce acute flares. ^{1 2 3 4 5}

Is ABP-671 (Allopurinol) generally safe for humans?

Allopurinol, also known as ABP-671, is generally safe for humans, but there are some concerns about rare allergic reactions that can be serious. Additionally, there are mixed findings about its safety compared to other similar medications, especially regarding heart-related side effects. ^{2 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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?

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

7

Recruited

880+

Findings from Research

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Lack of efficacy during the switch from brand to generic allopurinol. [2013]

3. Canada pubmed.ncbi.nlm.nih.gov

Urate-lowering therapy for the management of gout: a summary of 2 Cochrane reviews. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. [2015]

5. England 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. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Allopurinol hypersensitivity: a systematic review of all published cases, 1950-2012. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiovascular Safety Evaluation of Febuxostat and Allopurinol: Findings from the FDA Adverse Event Reporting System. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular safety of febuxostat compared to allopurinol for the treatment of gout: A systematic and meta-analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. [2022]