300 Participants Needed

Dapansutrile for Gout Flares

Recruiting at 52 trial locations
MN
PP
CO
Overseen ByClinical Operations
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.

Will I have to stop taking my current medications?

The trial protocol mentions that some medications might be prohibited during the study, but it doesn't specify which ones. You may need to stop certain medications, especially pain relievers like paracetamol/acetaminophen, close to the start of the trial. It's best to discuss your current medications with the trial team to get specific guidance.

How is the drug Dapansutrile different from other gout treatments?

Dapansutrile is unique because it is an oral medication that targets inflammation by inhibiting the NLRP3 inflammasome, a part of the immune system involved in inflammation, which is different from traditional gout treatments that primarily focus on lowering uric acid levels or using general anti-inflammatory drugs like NSAIDs.12345

Research Team

MN

Mustafa Noor, MD, FACP

Principal Investigator

Olatec Therapeutics LLC

Eligibility Criteria

This trial is for adults with a recent gout flare-up, diagnosed per specific criteria. Participants must understand the study and give consent. Excluded are those with visible tophi, allergies to the drug or similar drugs, infectious arthritis, recent COVID-19 infection, cancer treatments within a certain period, use of prohibited medications including paracetamol before baseline (except as rescue medication after day 4), other inflammatory arthritides, more than three joints with gout flares at screening or significant kidney disease.

Inclusion Criteria

I've had a gout flare-up in a joint within the last 4 days.
You have been diagnosed with gout based on specific criteria from 2015.
Provide written informed consent and understand and comply with all trial requirements
See 1 more

Exclusion Criteria

I don't have significant pain elsewhere that would affect my ability to judge my joint pain.
You are allergic to paracetamol/acetaminophen.
I might have an infection in my joint.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

96 hours
1 visit (in-person)

Treatment

Participants receive dapansutrile or placebo tablets with an initial loading dose followed by a twice daily maintenance dosing regimen for 7 days

7 days
3 visits (in-person) on Day 1, Day 4, and Day 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days
1 visit (in-person) on Day 15

Treatment Details

Interventions

  • Dapansutrile
  • Placebo Tablet
Trial OverviewThe trial is testing Dapansutrile tablets' effectiveness and safety in treating acute gout flare-ups compared to placebo tablets. Participants will be randomly assigned to receive either the active drug or an inactive placebo without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DapansutrileExperimental Treatment1 Intervention
An initial loading dose of 2000 mg dapansutrile on Day 1 followed by a maintenance regimen of 1000 mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Group II: Placebo TabletPlacebo Group1 Intervention
An initial loading dose of matching placebo (to mimic dapansutrile dosing) on Day 1 followed by a maintenance regimen of matching placebo twice daily starting 12 hours later through the second dose on Day 7, inclusive.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Olatec Therapeutics LLC

Lead Sponsor

Trials
10
Recruited
1,100+

Findings from Research

Gout treatment in patients with chronic kidney disease (CKD) stages 3-5 is complicated due to limited options and the risk of worsening kidney function, as highlighted by a review of 33 studies focusing on various treatments like colchicine and interleukin-1 inhibitors.
Most clinical trials have excluded patients with severe CKD, indicating a significant gap in understanding the efficacy and safety of gout treatments for this population, and emphasizing the need for future studies to include these patients and report outcomes based on their renal function.
Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review.Pisaniello, HL., Fisher, MC., Farquhar, H., et al.[2021]
Several new therapies for gout have emerged, focusing on lowering serum urate levels and treating gout flares, with verinurad being highlighted as the most promising urate-lowering therapy.
Arhalofenate shows potential for both urate lowering and anti-inflammatory effects, but further data is needed to confirm its efficacy and safety, along with other therapies like bucillamine and those in early development.
Expert opinion on emerging urate-lowering therapies.Stamp, LK., Merriman, TR., Singh, JA.[2018]
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.
Management of acute and chronic gouty arthritis: present state-of-the-art.Schlesinger, N.[2018]

References

Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review. [2021]
Expert opinion on emerging urate-lowering therapies. [2018]
Management of acute and chronic gouty arthritis: present state-of-the-art. [2018]
Canakinumab for the Patient With Difficult-to-Treat Gouty Arthritis: Review of the Clinical Evidence. [2020]
Pegloticase. An excessively dangerous and inadequately evaluated hypouricaemic drug. [2018]