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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, 48 and 60 hours; 8 and 15 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Adverse events
Change in joint pain in the target joint at scheduled time points post initial loading dose of study drug
Electrocardiograms
+7 moreTrial 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.
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Who is running the clinical trial?
Olatec Therapeutics LLCLead Sponsor
9 Previous Clinical Trials
759 Total Patients Enrolled
Mustafa Noor, MD, FACPStudy DirectorOlatec Therapeutics LLC
2 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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've had a gout flare-up in a joint within the last 4 days.I might have an infection in my joint.You have been diagnosed with gout based on specific criteria from 2015.I am not using any medications or therapies that are not allowed in this study.You have tested positive for COVID-19 within the past 4 weeks.I have chronic kidney disease or a history of kidney problems.I haven't taken any paracetamol/acetaminophen in the last 4 hours and won't during the study, except as provided by the study after Day 4.I am currently receiving or have recently received treatment for cancer.I am experiencing a gout flare in 4 or more joints.I have rheumatoid arthritis or another type of inflammatory arthritis.I have visible and touchable gout lumps.I am allergic to OLT1177® or similar medications.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Dapansutrile
- Group 2: Placebo Tablet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrollment size of this investigation?
"Affirmative, the clinicaltrials.gov database reveals that this medical study is still enrolling participants. Initially posted on 6th January 2022 and last updated 9th July 2023, 300 patients are needed to be recruited from one centre alone."
Answered by AI
Is there still opportunity for enrollment in this experiment?
"Yes, the published details on clinicaltrials.gov suggest that this trial is in progress and actively seeking participants. The study was originally posted on June 1st 2022 and amended most recently on September 1st 2023; it desires to recruit 300 patients from a single medical centre."
Answered by AI
Who else is applying?
What site did they apply to?
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
What portion of applicants met pre-screening criteria?
Did not meet criteria
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