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NLRP3 Inhibitor

Dapansutrile for Gout Flares

Phase 2 & 3

Recruiting

Research Sponsored by Olatec Therapeutics LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Known diagnosis of chronic kidney disease or known history of renal impairment

Evidence/suspicion of infectious/septic arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 24, 36, 48 and 60 hours; 8 and 15 days

Summary

This trial will test if a new drug is safe and effective for treating acute gout flare-ups.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, potential side effects of Dapansutrile may include allergic reactions due to hypersensitivity mentioned in exclusion criteria and possibly others related to its mechanism on inflammation pathways.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chronic kidney disease or a history of kidney problems.

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I might have an infection in my joint.

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I am not using any medications or therapies that are not allowed in this study.

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I am currently receiving or have recently received treatment for cancer.

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I am experiencing a gout flare in 4 or more joints.

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I have rheumatoid arthritis or another type of inflammatory arthritis.

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I have visible and touchable gout lumps.

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I am allergic to OLT1177® or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 24, 36, 48 and 60 hours; 8 and 15 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12, 24, 36, 48 and 60 hours; 8 and 15 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36, 48 and 60 hours; 8 and 15 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of IMP

Secondary study objectives

Adverse events

Change in joint pain in the target joint at scheduled time points post initial loading dose of study drug

Electrocardiograms

+7 more

Trial Design

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.

0 / 8Eligibility criteria met