Recruiting

Phase 2

Phase 3

DapansutrileStudy of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Sponsor:

Olatec Therapeutics LLC

Code:

NCT05658575

Conditions

Acute Gout Flare

Gout Attack

Gout Flare

Gouty Arthritis

Gout

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dapansutrile

Placebo Tablet

Study Details

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.

Conditions

Acute Gout Flare

Gout Attack

Gout Flare

Gouty Arthritis

Gout

Study ID

NCT05658575

Start date

Jan 6, 2023

Status verified date

Mar, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

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 [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Philip Piscitelli

+1 833-652-8321 phil.piscitelli@olatec.com

Clinical Operations

clinops@olatec.com

Locations

Arizona Arthritis & Rheumatology Associates - Glendale

Recruiting

Glendale, Arizona, United States, 85306

Contacts

Rebecca Martinez

480-350-7655 rebecca.martinez@azarthritis.com

Principal Investigator:

Mona Amin, MD

Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa

Recruiting

Mesa, Arizona, United States, 85210

Contacts

Rebecca 480-350-7655

480-350-7655 rebecca.martinez@azarthritis.com

Principal Investigator:

Swati Bharadwaj, MD

TriWest Research Associates

Recruiting

San Diego, California, United States, 92108

Contacts

Lennette Fontelar

619-334-4735 lfontelar@triwestresearch.com

Principal Investigator:

Arthur Ray Mabaquiao, MD

Valiance Clinical Research - Tarzana

Recruiting

Tarzana, California, United States, 91356

Contacts

Gail Ma

818-938-9167 g.ma@valianceclinicalresearch.com

Principal Investigator:

Richard Park, MD

Hillcrest Medical Research

Recruiting

DeLand, Florida, United States, 32720

Contacts

Larry Moulder

321-999-7616 lmoulder@hillcrestmedicalresearch.com

Principal Investigator:

John Hill, MD

SIMEDHealth

Recruiting

Gainesville, Florida, United States, 32607,

Contacts

Brandy Donahue-Quails

352-333-3885 Bdonahue-quails@simedresearch.com

Principal Investigator:

Timothy H Elder, MD

University of Florida Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Shannon Lloyd

904-633-0071 shannon.lloyd@ufhealth.org

Principal Investigator:

Gurjit Kaeley, MD

Well Pharma Medical Research

Recruiting

Miami, Florida, United States, 33173

Contacts

Ramon Perez Landaburo

305-665-4818 rperez@wpharma.com

Principal Investigator:

Eddie Armas, MD

Clinical Research of West Florida

Recruiting

Tampa, Florida, United States, 33765

Contacts

Jocelyn Evans

813-870-1292 jevans@crwf.com

Principal Investigator:

Lon Lynn, MD

Arthritis Center of North Georgia - Gainesville

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Cindy Valenzuela

770-531-3711 cvalenzuela@southeasternra.com

Principal Investigator:

Brent Flickinger, MD

Advanced Quality Medical Research

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Selahaddin Hocaoglu

312-823-6800 selahaddin@m1-health.com

Principal Investigator:

Dennis Levinson, MD

Montana Medical Research

Recruiting

Missoula, Montana, United States, 59808

Contacts

Eve Hickey

406-549-1124 ehickey@montanamedicalresearch.com

Principal Investigator:

Clancy Cone, MD

Lower Country Rheumatology - Summerville

Recruiting

Summerville, South Carolina, United States, 29486

Contacts

Eleanor Gardzalla

843-572-4840 egardzalla@articularishealthcare.com

Principal Investigator:

Jennifer Murphy, MD

Amarillo Center of Clinical Research

Recruiting

Amarillo, Texas, United States, 79124

Contacts

Vallen White

806-352-2453 vwhite@allergyarts.com

Principal Investigator:

Constantine Saadeh, MD

Utah Health - University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Julieanne Hall

801-213-1558 julieanne.hall@hsc.utah.edu

Principal Investigator:

Naomi Schlessinger, MD

Arthritis Northwest

Recruiting

Spokane, Washington, United States, 99204

Contacts

Terri Cone

509-838-6500 tcone@arthritisnw.com

Principal Investigator:

Christopher Wright, MD

More Information

Sponsor

Olatec Therapeutics LLC

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Olatec Therapeutics LLC on 2026-03-11.