RECRUITING

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

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Conditions

Acute Gout FlareGout AttackGout FlareGouty ArthritisGoutArthritisJoint Painmono-articular arthritisNLRP3NLRP3 inhibitordapansutrileOLT1177inflammationgouty InflammationinflammasomesIL-1 betaIL-1 inflammationautoinflammatory conditionshyperuricemiauric acid crystalflaresmall-moleculetherapeutic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Quick Facts

Study Start:2023-01-06
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05658575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female subjects age 18 or older
  2. * Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria:
  3. * Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening/Baseline Visit
  4. * Provide written informed consent and understand and comply with all trial requirements
  1. * Presence of any palpable and visible tophi by physical examination
  2. * Has ≥ 4 joints with an acute gout flare at Screening/Baseline
  3. * Presence of active rheumatoid arthritis or other acute inflammatory arthritis
  4. * Evidence/suspicion of infectious/septic arthritis
  5. * 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
  6. * Known diagnosis of chronic kidney disease or known history of renal impairment
  7. * Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening/Baseline
  8. * Active malignancy or recent malignancy with any systemic anti-cancer treatment
  9. * Has a hypersensitivity or allergy to OLT1177® or other drugs in its class
  10. * Hypersensitivity or allergy to paracetamol/acetaminophen
  11. * 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
  12. * 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

Contacts and Locations

Study Contact

Philip Piscitelli
CONTACT
+1 833-652-8321
phil.piscitelli@olatec.com
Clinical Operations
CONTACT
clinops@olatec.com

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, 85306
United States
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, Arizona, 85210
United States
American Institute of Research
Los Angeles, California, 90017
United States
TriWest Research Associates
San Diego, California, 92108
United States
Valiance Clinical Research - Tarzana
Tarzana, California, 91356
United States
Hillcrest Medical Research
DeLand, Florida, 32720
United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32256
United States
Well Pharma Medical Research
Miami, Florida, 33173
United States
Clinical Research of West Florida
Tampa, Florida, 33765
United States
Arthritis Center of North Georgia - Gainesville
Gainesville, Georgia, 30501
United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640
United States
Clinical Trial Site
Orland Park, Illinois, 60462
United States
The Research Group of Lexington
Lexington, Kentucky, 40503
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Montana Medical Research
Missoula, Montana, 59808
United States
NYU Langone
New York, New York, 10016
United States
IMA Clinical Research - Manhattan
New York, New York, 10036
United States
Altoona Research
Duncansville, Pennsylvania, 16635
United States
Lower Country Rheumatology - Summerville
Summerville, South Carolina, 29486
United States
Amarillo Center of Clinical Research
Amarillo, Texas, 79124
United States
Utah Health - University of Utah Hospital
Salt Lake City, Utah, 84108
United States
Clinical Trial Site
Bothell, Washington, 98021
United States
Arthritis Northwest
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Olatec Therapeutics LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-06
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-01-06
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • gout
  • gouty arthritis
  • mono-articular arthritis
  • NLRP3
  • NLRP3 inhibitor
  • dapansutrile
  • OLT1177
  • joint pain
  • inflammation
  • gouty Inflammation
  • inflammasomes
  • IL-1 beta
  • IL-1 inflammation
  • autoinflammatory conditions
  • hyperuricemia
  • uric acid crystal
  • flare
  • small-molecule
  • therapeutic

Additional Relevant MeSH Terms

  • Acute Gout Flare
  • Gout Attack
  • Gout Flare
  • Gouty Arthritis
  • Gout
  • Arthritis
  • Joint Pain