ABP-671 for Gout
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ABP-671 for individuals with gout, a condition that causes painful joint inflammation. The researchers aim to understand how ABP-671 interacts with Allopurinol, a common gout medication, when used together. Suitable participants should have gout, maintain a stable Allopurinol routine for at least two weeks, and have either normal or moderately impaired kidney function, which affects medication processing. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
You will need to continue taking your current Allopurinol medication as part of the study.
Is there any evidence suggesting that ABP-671 is likely to be safe for humans?
Research has shown that ABP-671 is generally well-tolerated. In earlier studies, participants took various doses of ABP-671 without major issues. For example, doses ranging from 0.1 to 1.0 mg were used safely. Participants did not report serious side effects, and the drug was considered safe.
ABP-671 has also been tested in individuals with high uric acid levels and gout. These studies found the drug to be safe and manageable. It is important to note that ABP-671 is still under investigation, so researchers continue to closely monitor its safety.12345Why do researchers think this study treatment might be promising?
Most treatments for gout, like allopurinol and febuxostat, focus on lowering uric acid levels to prevent flare-ups. But ABP-671 is different because it introduces a novel mechanism of action by targeting a specific enzyme in the uric acid production pathway, potentially offering a more precise approach. Researchers are excited about ABP-671 because it could provide faster relief with fewer side effects, addressing some limitations of current treatments. This innovative approach could make managing gout more effective and comfortable for patients.
What evidence suggests that ABP-671 might be an effective treatment for gout?
Research has shown that ABP-671, the investigational treatment in this trial, holds promise for treating gout. In earlier studies, ABP-671 successfully lowered uric acid levels in the blood, a crucial factor in managing gout. Some patients even experienced uric acid levels dropping below 6 mg/dL, an important treatment goal. Additionally, ABP-671 has demonstrated the ability to dissolve tophi, the painful lumps of uric acid crystals in the joints. These findings suggest that ABP-671 could effectively control gout symptoms and complications.12467
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with gout who have been taking allopurinol daily for at least 14 days. Participants are divided into two groups based on kidney function: one with normal and another with moderate impairment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABP-671 in combination with stable Allopurinol therapy to evaluate pharmacokinetic interactions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABP-671
Trial Overview
The study tests how ABP-671 interacts with allopurinol in patients already using allopurinol for gout. It's an open-label trial, meaning everyone knows which drugs are given, and it measures the drug levels in the body.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atom Therapeutics Co., Ltd
Lead Sponsor
Citations
Atom Therapeutics Announces Positive Topline Results of ...
During a treatment period of only 6 months, ABP-671 demonstrated good efficacy in dissolving tophi with remarkable reduction in gouty stone ...
2.
fiercebiotech.com
fiercebiotech.com/biotech/atom-claims-phase-3-win-shows-gout-drug-can-beat-competition-efficacy-safetyAtom claims phase 3 win shows gout drug can beat ...
Not only did the study show that patients receiving ABP-671 were more likely to see their serum uric acid levels fall below 6 mg/dL than those ...
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics ...
In the MAD study, hyperuricemic but otherwise healthy subjects received 0.2, 0.5, or 1.0 mg/d of ABP-671 or placebo oral solutions for 10 days.
Atom Therapeutics to Present Positive Data from Clinical ...
The Phase 2a trial of ABP-671 enrolled 45 chronic gout patients with mild-to-moderate kidney abnormalities. They were randomized to five oral ...
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 ...
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 ...
A Phase 2a Study to Evaluate the Safety, Tolerability ...
Conclusion: ABP-671 has acceptable safety and tolerability in Chinese subjects with hyperuricemia or gout. ... ABP-671 in Subjects with Hyperuricemia or Gout in ...
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