380 Participants Needed

ABP-745 for Gout

Recruiting at 42 trial locations
US
Overseen ByUllrich Schwertschlag, MD,PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Atom Therapeutics Co., Ltd
Must be taking: ULT agents
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABP-745, a potential drug for acute gout, a type of arthritis that causes sudden and severe joint pain and swelling. The goal is to determine if ABP-745 can reduce pain and swelling more effectively than the usual treatment, colchicine, or a placebo (a look-alike pill with no active drug). Participants will be divided into groups to receive different doses of ABP-745, colchicine, or a placebo. Candidates may qualify if they have experienced at least two gout flare-ups in the past year and are currently undergoing an acute gout attack. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are taking medications for gout like allopurinol, febuxostat, or probenecid, you must stay on a stable dose throughout the study. However, you cannot take certain other medications like prednisone, NSAIDs, or colchicine shortly before starting the trial.

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

Earlier studies have shown that ABP-745 is safer and easier to tolerate than current gout medications. Research on animals and early human tests suggest that this treatment is generally well-received. Reports indicate that ABP-745 effectively reduces symptoms of acute gout, such as pain and swelling, with fewer safety issues. Animal studies also support its good safety profile. This suggests that ABP-745 might be a safer choice for managing gout flare-ups compared to some existing treatments.12345

Why do researchers think this study treatment might be promising for gout?

Researchers are excited about ABP-745 for gout because it targets inflammation in a potentially more effective way than current treatments. Unlike standard options like allopurinol and colchicine, which primarily aim to lower uric acid levels or reduce inflammation, ABP-745 may work through a novel mechanism that directly tackles the inflammatory pathways involved in gout attacks. This new approach could lead to faster relief of symptoms and improved long-term outcomes for patients dealing with this painful condition. With two different doses being explored, ABP-745 offers hope for a more tailored and efficient treatment option.

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

Research shows that ABP-745 is designed to alleviate pain and swelling from sudden gout attacks. Early studies with healthy participants suggest that the drug is generally safe and does not cause major side effects. While specific results on its effectiveness for gout are not yet available, the treatment aims to avoid the safety issues often associated with current gout medications. ABP-745 reduces inflammation, which is crucial for managing gout symptoms. Participants in this trial may receive varying doses of ABP-745, Colchicine, or a placebo for comparison.13678

Are You a Good Fit for This Trial?

This trial is for individuals experiencing an acute gout flare-up. Participants should have a history of gout and be currently suffering from pain and swelling due to the condition. Specific inclusion or exclusion criteria are not provided, but typically these would relate to overall health status, age range, and possibly previous treatments.

Inclusion Criteria

I have been diagnosed with gouty arthritis.
Body mass index (BMI) 18-40 kg/m2 (inclusive)
I have had a gout flare-up in the last 6 months.
See 4 more

Exclusion Criteria

I am taking medication to prevent gout flares as discussed.
I haven't taken high-dose steroids or narcotics, or had steroid injections recently.
I may have taken NSAIDs before starting the study drug, as decided by my doctor.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ABP-745 or colchicine or placebo to evaluate efficacy in reducing pain and swelling

24 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ABP-745
Trial Overview The study tests ABP-745 at two different doses against colchicine (a standard treatment) and a placebo in reducing pain and swelling during a gout attack. It's randomized (participants are assigned randomly to one of the groups) and double-blind (neither participants nor researchers know who gets which treatment).
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ABP-745 Dose BExperimental Treatment1 Intervention
Group II: ABP-745 Dose AExperimental Treatment1 Intervention
Group III: ColchicineActive Control1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atom Therapeutics Co., Ltd

Lead Sponsor

Citations

Safety and Efficacy of ABP-745 in Participants With an ...Efficacy of ABP-745 in reducing pain and swelling compared with standard colchicine treatment and placebo will be evaluated in participants with ...
Atom Therapeutics to Present Positive Data from Clinical ...The Phase 1 study of ABP-745 in healthy volunteers demonstrated the drug was well-tolerated and exhibited dose proportional pharmacokinetics ...
Atom Therapeutics Launches Global Phase II Trial of Novel ...ABP-745 is designed to relieve acute gout flare symptoms while minimizing safety concerns linked to current treatments. The Phase II trial will ...
Atom Therapeutics Enrolls First Patient in Multicenter ...Atom has enrolled the first patient in a multi-country Phase 2 trial of ABP-745 for treatment of painful acute gout flares.
Atom Therapeutics to Present Positive Data from Clinical ...Data from a Phase 1 trial of ABP-745, an anti-inflammatory drug for acute gout flares, demonstrated a good safety profile and good ...
Acute GoutIn addition, the nonclinical and Phase 1 clinical data showed that ABP-745 exhibited higher safety and tolerability compared to existing drugs on the market.
Atom Therapeutics to Present Positive Data from Clinical ...Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of inflammation. Phase 2 clinical trials with ABP ...
ABP-745 - Drug Targets, Indications, PatentsResults from multiple clinical trials have demonstrated that lingdolinurad is safe and effective at multiple dose levels (from 1 mg to 12 mg). The 2 mg once- ...
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