Dapansutrile for Gout Flares

Recruiting at 57 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Olatec Therapeutics LLC

Must not be taking: Paracetamol, Acetaminophen, others

Disqualifiers: Tophi, Rheumatoid arthritis, Kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 7 days

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of dapansutrile tablets for individuals experiencing sudden gout flare-ups. Gout, a type of arthritis, causes intense pain and swelling, often in the big toe. Participants will receive either the experimental dapansutrile or a placebo (a pill with no active medicine) to compare results. Individuals who have experienced at least two gout flare-ups in the past 18 months and are currently experiencing a flare may qualify to join. As a Phase 2/3 trial, this study evaluates the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potential new therapies.

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.

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

Research has shown that dapansutrile is likely safe. Studies have found that people with gout flare-ups tolerate it well. Reports indicate that it helps reduce joint pain, and no serious side effects have been linked to it. This suggests that, so far, patients have not experienced harmful reactions. The trial is in a late stage, which usually indicates the treatment has passed earlier tests without major safety issues. ^{1 2 3 4 5}

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

Most treatments for gout flares, like NSAIDs and corticosteroids, aim to reduce inflammation and pain. But dapansutrile works differently, targeting the NLRP3 inflammasome, a key component in the inflammatory process. This novel mechanism could mean fewer side effects compared to traditional options. Researchers are excited because dapansutrile may offer a more targeted approach, potentially leading to quicker and more effective relief for gout sufferers.

What evidence suggests that dapansutrile might be an effective treatment for gout flares?

Research has shown that dapansutrile, which participants in this trial may receive, can help treat gout flares. Past studies found it reduced joint pain and swelling during a gout flare. Dapansutrile blocks a part of the body's inflammation process, reducing swelling in the joints and elsewhere. Participants in those studies noticed symptom improvement, suggesting dapansutrile could be a promising treatment for sudden gout flares. ^{1 2 3 4 5}

Who Is on the Research Team?

Mustafa Noor, MD, FACP

Principal Investigator

Olatec Therapeutics LLC

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dapansutrile
• Placebo Tablet

Trial Overview The 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.

How Is the Trial Designed?

Group I: Dapansutrile Experimental Treatment 1 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 Tablet Placebo Group 1 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.

Who Is Running the Clinical Trial?

Olatec Therapeutics LLC

Lead Sponsor

Trials

10

Recruited

1,100+

Published Research Related to This Trial

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]

Canakinumab, administered as a single dose during acute gout flares, provided rapid and effective pain relief while also suppressing future flares and inflammation in patients who cannot use NSAIDs or colchicine, based on two phase 3 studies.

In comparison to the active treatment triamcinolone acetonide, canakinumab was consistently more effective and well tolerated, making it a suitable option for patients with frequent gout attacks and multiple comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canakinumab for the Patient With Difficult-to-Treat Gouty Arthritis: Review of the Clinical Evidence. Bardin, T.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert opinion on emerging urate-lowering therapies. Stamp, LK., Merriman, TR., Singh, JA.[2018]

Pegloticase, a treatment for severe gout, can lower uric acid levels but may increase gout flare-ups and has only minor effects on pain and disability, based on two 6-month trials with 212 patients.

Due to serious potential side effects, including anaphylaxis and infusion reactions, probenecid is recommended as a safer alternative when allopurinol fails, while pegloticase should be avoided unless absolutely necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegloticase. An excessively dangerous and inadequately evaluated hypouricaemic drug. [2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05658575

NCT05658575 | Study of Dapansutrile Tablets in Subjects ... The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare. Detailed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7523621/

Dapansutrile, an oral selective NLRP3 inflammasome ... In conclusion, dapansutrile reduced target joint pain, and joint and systemic inflammation, in individuals with a monoarticular gout flare and had an acceptable ...

3. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30065-5/abstract

Dapansutrile, an oral selective NLRP3 inflammasome ... In this study we aimed to investigate the safety and efficacy of orally administered dapansutrile in patients with a gout flare.

4. trialx.com trialx.com/clinical-trials/listings/228734/study-of-dapansutrile-tablets-in-subjects-with-an-acute-gout-flare/

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

5. trials.arthritis.org trials.arthritis.org/trials/NCT05658575

Study of Dapansutrile Tablets in Subjects With an Acute Gout ... The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.