Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
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
1 other identifier
interventional
300
5 countries
40
Brief Summary
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2023
Typical duration for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2022
CompletedFirst Posted
Study publicly available on registry
December 20, 2022
CompletedStudy Start
First participant enrolled
January 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
March 11, 2026
March 1, 2026
4 years
November 29, 2022
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
72 hours
Secondary Outcomes (13)
Change in joint pain in the target joint at scheduled time points post initial loading dose of study drug
12, 24, 36, 48 and 60 hours; 8 and 15 days
To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion).
4 and 8 days
To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion)
8 and 15 days
To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion).
4 and 8 days
To further assess the clinical activity of dapansutrile compared to placebo in reducing joint pain at scheduled time points post initial loading dose of IMP.
48 and 72 hours; 8 and 15 days
- +8 more secondary outcomes
Study Arms (2)
Dapansutrile
EXPERIMENTALAn 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
PLACEBO COMPARATORAn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
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
SIMEDHealth
Gainesville, Florida, 32607,, 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
Advanced Quality Medical Research
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
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
Bordeaux, 33076, France
Hôpital Saint Philibert
Lomme, 59462, France
Hôpital Lariboisière
Paris, France
CHU de Rouen - Hôpital Charles-Nicolle
Rouen, France
Emek Medical Center
Afula, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Rabin Medical Center - Beilinson and Hasharon
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5266202, Israel
Reade Research BV
Amsterdam, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
Hospital Universitario san Juan de Alicante
Alicante, 03010, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2022
First Posted
December 20, 2022
Study Start
January 6, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03