Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Olatec Therapeutics LLC
Sponsor
Olatec Therapeutics LLC
Information Provided by (Responsible Party)
Olatec Therapeutics LLC
Clinicaltrials.gov Identifier
NCT05658575
Other Study ID Numbers:
OLT1177-08
First Submitted
November 28, 2022
First Posted
December 19, 2022
Last Update Posted
March 10, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

This is a multi-center Phase 2/3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study of dapansutrile (OLT1177®), a specific NLRP3 inhibitor, conducted in subjects with acute gout flare. Up to 300 eligible subjects will be randomized 2:1 to one of two treatment arms to receive either dapansutrile tablets or matching placebo twice daily for 7 days. An initial loading dose on Study Day 1 will be followed by a twice daily maintenance dosing regimen.

Subjects presenting with acute gout flare that began within 96 hours prior to the Baseline/Day 1 visit will be evaluated for eligibility. Subjects who are determined to be eligible will be randomized into either an active treatment arm (2/3 of the subjects enrolled) or the placebo arm (1/3 of the subjects enrolled).

Eligible subjects who are randomized into the study will also be provided with rescue medication at the Baseline/Day 1 Visit. No other pain medications, anti-inflammatory drugs (e.g., steroids or nonsteroidal anti-inflammatory drugs), or treatments for gout flare are allowed during the Treatment Period.

During the Treatment Period, subjects will return to the clinic trial site on Day 4 and, following the 7-day Treatment Period, subjects will return to the clinical trial site on Day 8, and then Day 15 with safety data collected through Day 36.

Condition or DiseaseIntervention/Treatment
Acute Gout FlareGout AttackGout FlareGouty ArthritisGoutArthritisJoint Pain
Drug: DapansutrileOther: Placebo Tablet

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateJanuary 5, 2023
Actual Primary Completion Date7mos 1w from now
Actual Study Completion Date8mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Drug: 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.
Other: 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.

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  1. Change in joint pain in the target joint at scheduled time points post initial loading dose of study drug
    Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at specified timepoints up to Day 15 post initial loading dose of study drug. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.
  2. 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).
    Patient Global Assessment of Response to Treatment (PGART) will be completed by the subject through Day 8. The PGART is a 5-level Likert-type single item (i.e., one general question the Subject is asked to answer) about the overall perceived status of their response to treatment on a scale from "None" to "Excellent".
  3. 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)
    Change from baseline in the Investigator-assessed Target Joint Score at scheduled assessments through Study Day 15. The Investigator-assessed Target Joint Score is a combined assessment of individual assessments for the following outcome domains: tenderness, swelling, erythema, warmth, and range of motion each with a scale of 0 through 3, with lower scoring in each domain indicating better outcomes in the respective domain.
  4. 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).
    Investigator Global Assessment of Response to Treatment (IGART) will be completed by the Investigator through Study Day 8. The IGART is a 5-level Likert-type single item (i.e., one general question the Investigator is asked to answer) about the overall perceived status of the subject's response to treatment on a scale from "None" to "Excellent".
  5. 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.
    Proportion of subjects with a response (defined as a 20%, 50%, or 70% reduction from baseline without using Rescue Medication) in the subject-assessed pain intensity score (100-mm VAS) in the target joint up to Day 15 post initial loading dose of study drug.
  6. 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).
    Change from baseline in the subject-assessed Quality of Life (QoL) questionnaire Short Form Health Survey-12 version 2.0 (SF-12v2) at scheduled assessments through Study Day 15.
  7. 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.
    Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in any actively flaring non-target joint(s) up to Day 15 post initial loading dose of study drug. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.
  8. To characterize the population PK of dapansutrile and exposure-response relationship for efficacy and safety.
    Blood samples will be drawn and analyzed in order to characterize the population PK of dapansutrile
  9. Physical examinations
    Physical examinations will be conducted to assess changes in subject health throughout the duration of the study.
  10. Vital signs
    Vital signs consisting of pulse, resting blood pressure, temperature and respirations will be recorded and analyzed for changes throughout the duration of the study
  11. Electrocardiograms
    Electrocardiograms will be captured and analyzed for changes throughout the duration of the study.
  12. Safety laboratory measurements
    Blood samples will be drawn and analyzed for routine chemistry blood markers, routine hematology/complete blood count and routine urinalysis will be performed throughout the duration of the study
  13. Adverse events
    Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsOlatec Therapeutics LLC
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35294Arizona Arthritis & Rheumatology Associates - Glendale | Glendale Arizona, United States, 85306Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa | Mesa Arizona, United States, 85210American Institute of Research | Los Angeles California, United States, 90017TriWest Research Associates | San Diego California, United States, 92108Valiance Clinical Research - Tarzana | Tarzana California, United States, 91356Hillcrest Medical Research | DeLand Florida, United States, 32720SIMEDHealth | Gainesville Florida, United States, 32607,University of Florida Health Jacksonville | Jacksonville Florida, United States, 32256Well Pharma Medical Research | Miami Florida, United States, 33173Clinical Research of West Florida | Tampa Florida, United States, 33765Arthritis Center of North Georgia - Gainesville | Gainesville Georgia, United States, 30501Great Lakes Clinical Trials | Chicago Illinois, United States, 60640Advanced Quality Medical Research | Orland Park Illinois, United States, 60462The Research Group of Lexington | Lexington Kentucky, United States, 40503University of Michigan | Ann Arbor Michigan, United States, 48109Montana Medical Research | Missoula Montana, United States, 59808NYU Langone | New York New York, United States, 10016IMA Clinical Research - Manhattan | New York New York, United States, 10036Altoona Research | Duncansville Pennsylvania, United States, 16635Lower Country Rheumatology - Summerville | Summerville South Carolina, United States, 29486Amarillo Center of Clinical Research | Amarillo Texas, United States, 79124Utah Health - University of Utah Hospital | Salt Lake City Utah, United States, 84108Clinical Trial Site | Bothell Washington, United States, 98021Arthritis Northwest | Spokane Washington, United States, 99204Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin | Bordeaux , France, 33076Hôpital Saint Philibert | Lomme , France, 59462Hôpital Lariboisière | Paris , France, CHU de Rouen - Hôpital Charles-Nicolle | Rouen , France, Emek Medical Center | Afula , Israel, Carmel Medical Center | Haifa , Israel, 3436212Rabin Medical Center - Beilinson and Hasharon | Petah Tikva , Israel, 49100The Chaim Sheba Medical Center | Ramat Gan , Israel, 5266202Reade Research BV | Amsterdam , Netherlands, Maastricht Universitair Medisch Centrum | Maastricht , Netherlands, 6229 HXVieCuri Medisch Centrum | Venlo , Netherlands, Hospital Universitario san Juan de Alicante | Alicante , Spain, 03010Hospital de la Santa Creu i Sant Pau | Barcelona , Spain, 08025Hospital Universitario de La Princesa | Madrid , Spain, 28006Hospital Universitario Infanta Leonor | Madrid , Spain, 28031