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Recruiting Phase 2/3

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

NCT05658575 · tracked via the Priya Life Science Spain tracker
Sponsor
Olatec Therapeutics, Inc
Phase
Phase 2/3
Started
2023-01-06
Last updated
2026-03-11

Condition(s) studied

Acute Gout FlareGout AttackGout FlareGouty ArthritisGoutArthritisJoint Pain

Investigational drug(s) / intervention(s)

Dapansutrile →Placebo Tablet

Dapansutrile: 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.

Placebo Tablet: 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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male and female subjects age 18 or older * Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria: A) Diagnosis of gout must be confirmed in the target joint as indicated by either the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint or bursa OR by imaging evidence of urate deposition in the target joint or bursa at the Screening/Baseline Visit/Study Day 1, or B) Documented history in the target joint or bursa ; or documented history of 2 or more gout flares in the previous 18 months * Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening/Baseline Visit * Provide written informed consent and understand and comply with all trial requirements Exclusion Criteria: * Presence of any palpable and visible tophi by physical examination * Has ≥ 4 joints with an acute gout flare at Screening/Baseline * Presence of active rheumatoid arthritis or other acute inflammatory arthritis * Evidence/suspicion of infectious/septic arthritis * Clinically significant general pain or non-gout-related joint pain that would interfere with the subject's ability to accurately assess pain in the target joint * Known diagnosis of chronic kidney disease or known history of renal impairment * Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening/Baseline * Active malignancy or recent malignancy with any systemic anti-cancer treatment * Has a hypersensitivity or allergy to OLT1177® or other drugs in its class * Hypersensitivity or allergy to paracetamol/acetaminophen * Use of any prohibited concomitant medications/therapies over the periods defined in the protocol or planned use of any prohibited concomitant medications/therapies during the Treatment Period (including the use of paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit or other pain medications within 12 hours prior to the Screening/ Baseline Visit * Use of any product containing paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit or planned use during the Treatment Period (with the exception of study-provided Rescue Medication \[paracetamol/acetaminophen\], which is permitted after completion of the first target joint pain assessment on Study Day 4

Primary outcome measure(s)

  • 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 — 72 hours
    Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.

Trial sites (40)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Withdrawn
Arizona Arthritis & Rheumatology Associates - Glendale Glendale Arizona Recruiting
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa Mesa Arizona Recruiting
American Institute of Research Los Angeles California Withdrawn
TriWest Research Associates San Diego California Recruiting
Valiance Clinical Research - Tarzana Tarzana California Recruiting
Hillcrest Medical Research DeLand Florida Recruiting
SIMEDHealth Gainesville Florida Recruiting
University of Florida Health Jacksonville Jacksonville Florida Recruiting
Well Pharma Medical Research Miami Florida Recruiting
Clinical Research of West Florida Tampa Florida Recruiting
Arthritis Center of North Georgia - Gainesville Gainesville Georgia Recruiting
Great Lakes Clinical Trials Chicago Illinois Withdrawn
Advanced Quality Medical Research Orland Park Illinois Recruiting
The Research Group of Lexington Lexington Kentucky Active Not Recruiting
University of Michigan Ann Arbor Michigan Withdrawn
Montana Medical Research Missoula Montana Recruiting
NYU Langone New York New York Active Not Recruiting
IMA Clinical Research - Manhattan New York New York Withdrawn
Altoona Research Duncansville Pennsylvania Withdrawn
Lower Country Rheumatology - Summerville Summerville South Carolina Recruiting
Amarillo Center of Clinical Research Amarillo Texas Recruiting
Utah Health - University of Utah Hospital Salt Lake City Utah Recruiting
Clinical Trial Site Bothell Washington Withdrawn
Arthritis Northwest Spokane Washington Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin Bordeaux France Recruiting
Hôpital Saint Philibert Lomme France Recruiting
Hôpital Lariboisière Paris France Recruiting
CHU de Rouen - Hôpital Charles-Nicolle Rouen France Recruiting
Emek Medical Center Afula Israel Recruiting
Carmel Medical Center Haifa Israel Recruiting
Rabin Medical Center - Beilinson and Hasharon Petah Tikva Israel Recruiting
The Chaim Sheba Medical Center Ramat Gan Israel Recruiting
Reade Research BV Amsterdam Netherlands Recruiting
Maastricht Universitair Medisch Centrum Maastricht Netherlands Recruiting
VieCuri Medisch Centrum Venlo Netherlands Recruiting
Hospital Universitario san Juan de Alicante Alicante Spain Withdrawn
Hospital de la Santa Creu i Sant Pau Barcelona Spain Recruiting
Hospital Universitario de La Princesa Madrid Spain Recruiting
Hospital Universitario Infanta Leonor Madrid Spain Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05658575 on ClinicalTrials.gov ↗ ← All trials in Spain