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
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
WITHDRAWN
Birmingham
Arizona
Arizona Arthritis & Rheumatology Associates - Glendale
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
Hôpital Saint Philibert
RECRUITING
Lomme
Hôpital Lariboisière
RECRUITING
Paris
CHU de Rouen - Hôpital Charles-Nicolle
RECRUITING
Rouen
Israel
Emek Medical Center
RECRUITING
Afula
Carmel Medical Center
RECRUITING
Haifa
Rabin Medical Center - Beilinson and Hasharon
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Netherlands
Reade Research BV
RECRUITING
Amsterdam
Maastricht Universitair Medisch Centrum
RECRUITING
Maastricht
VieCuri Medisch Centrum
RECRUITING
Venlo
Spain
Hospital Universitario san Juan de Alicante
WITHDRAWN
Alicante
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario Infanta Leonor
RECRUITING
Madrid
Contact Information
Primary
Philip Piscitelli
phil.piscitelli@olatec.com
+1 833-652-8321
Backup
Clinical Operations
clinops@olatec.com
Time Frame
Start Date:2023-01-06
Estimated Completion Date:2026-08-31
Participants
Target number of participants:300
Treatments
Experimental: 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_comparator: 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.