Acute Gout FlarePhase 2/3NCT05658575
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
A Phase 2/3 study testing Dapansutrile in people with Acute Gout Flare and Gout Attack, run by Olatec Therapeutics, Inc. at 40 sites in 5 countries.
Trial summary
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gout Flare, Gout Attack, Gout Flare
- What is being tested?
- Dapansutrile
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 40 sitesin 5 countries
- Study dates
- 6 Jan 2023to 31 Jan 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects age 18 or older
- Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria:
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
40 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Clinical Operations contact
40 sites in 5 countries
United States25 sites, 16 recruiting
- Recruiting
Amarillo Center of Clinical Research
Amarillo, Texas, 79124
Vallen White, 806-352-2453, vwhite@allergyarts.com
Constantine Saadeh, MD
- Withdrawn
University of Michigan
Ann Arbor, Michigan, 48109
- Withdrawn
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Withdrawn
Clinical Trial Site
Bothell, Washington, 98021
- Withdrawn
Great Lakes Clinical Trials
Chicago, Illinois, 60640
- Recruiting
Hillcrest Medical Research
DeLand, Florida, 32720
Larry Moulder, 321-999-7616, lmoulder@hillcrestmedicalresearch.com
John Hill, MD
- Withdrawn
Altoona Research
Duncansville, Pennsylvania, 16635
- Recruiting
SIMEDHealth
Gainesville, Florida, 32607,
Brandy Donahue-Quails, 352-333-3885, Bdonahue-quails@simedresearch.com
Timothy H Elder, MD
- Recruiting
Arthritis Center of North Georgia - Gainesville
Gainesville, Georgia, 30501
Cindy Valenzuela, 770-531-3711, cvalenzuela@southeasternra.com
Brent Flickinger, MD
- Recruiting
Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, 85306
Rebecca Martinez, 480-350-7655, rebecca.martinez@azarthritis.com
Mona Amin, MD
- Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida, 32256
Shannon Lloyd, 904-633-0071, shannon.lloyd@ufhealth.org
Gurjit Kaeley, MD
- Active, not recruiting
The Research Group of Lexington
Lexington, Kentucky, 40503
- Withdrawn
American Institute of Research
Los Angeles, California, 90017
- Recruiting
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, Arizona, 85210
Rebecca 480-350-7655, 480-350-7655, rebecca.martinez@azarthritis.com
Swati Bharadwaj, MD
- Recruiting
Well Pharma Medical Research
Miami, Florida, 33173
Ramon Perez Landaburo, 305-665-4818 ext. 231, rperez@wpharma.com
Eddie Armas, MD
- Recruiting
Montana Medical Research
Missoula, Montana, 59808
Eve Hickey, 406-549-1124, ehickey@montanamedicalresearch.com
Clancy Cone, MD
- Active, not recruiting
NYU Langone
New York, New York, 10016
- Withdrawn
IMA Clinical Research - Manhattan
New York, New York, 10036
- Recruiting
Advanced Quality Medical Research
Orland Park, Illinois, 60462
Selahaddin Hocaoglu, 312-823-6800, selahaddin@m1-health.com
Dennis Levinson, MD
- Recruiting
Utah Health - University of Utah Hospital
Salt Lake City, Utah, 84108
Julieanne Hall, 801-213-1558, julieanne.hall@hsc.utah.edu
Naomi Schlessinger, MD
- Recruiting
TriWest Research Associates
San Diego, California, 92108
Lennette Fontelar, 619-334-4735, lfontelar@triwestresearch.com
Arthur Ray Mabaquiao, MD
- Recruiting
Arthritis Northwest
Spokane, Washington, 99204
Terri Cone, 509-838-6500, tcone@arthritisnw.com
Christopher Wright, MD
- Recruiting
Lower Country Rheumatology - Summerville
Summerville, South Carolina, 29486
Eleanor Gardzalla, 843-572-4840, egardzalla@articularishealthcare.com
Jennifer Murphy, MD
- Recruiting
Clinical Research of West Florida
Tampa, Florida, 33765
Jocelyn Evans, 813-870-1292 ext. 129, jevans@crwf.com
Lon Lynn, MD
- Recruiting
Valiance Clinical Research - Tarzana
Tarzana, California, 91356
Gail Ma, 818-938-9167, g.ma@valianceclinicalresearch.com
Richard Park, MD
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
Bordeaux, 33076
Clinical Contact
Marie-Elise Truchetet, MD
- Recruiting
Hôpital Saint Philibert
Lomme, 59462
Clinical Contact
Tristan Pascart, MD
- Recruiting
Hôpital Lariboisière
Paris
Clinical Contact
- Recruiting
CHU de Rouen - Hôpital Charles-Nicolle
Rouen
Clinical Contact
Israel4 sites, 4 recruiting
- Recruiting
Emek Medical Center
Afula
Clinical Contact
Amir Bieber, MD
- Recruiting
Carmel Medical Center
Haifa, 3436212
Noga Cohen, (+972)5240434341, nogacoh@clalit.org.il
Devy Zisman, MD
- Recruiting
Rabin Medical Center - Beilinson and Hasharon
Petah Tikva, 49100
Yosra Khateb, (+972)39377105, yusrakha@clalit.org.il
Elisheva Pokroy-Shapira, MD
- Recruiting
The Chaim Sheba Medical Center
Ramat Gan, 5266202
Revital Nawi, (+972)526668127, revital.nawi@sheba.health.gov.il
Howard Amital, MD
Spain4 sites, 3 recruiting
- Withdrawn
Hospital Universitario san Juan de Alicante
Alicante, 03010
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Júlia Bernárdez, (+34)935537112, JBernardez@santpau.cat
Cesar Diaz Torne, MD
- Recruiting
Hospital Universitario de La Princesa
Madrid, 28006
Helena Vazquez, (+34)915202473, helena.vazquez@salud.madrid.org
Esther Vicente Rabaneda, MD
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
Pedro Torres, (+34)676146368, pedro.a.torresgomez.sc@gmail.com
Enrique Calvo Aranda, MD
Netherlands3 sites, 3 recruiting
- Recruiting
Reade Research BV
Amsterdam
Clinical Contact
Martijn Gerritsen, MD
- Recruiting
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
Christel Mertens, (+31)0433072099, christel.mertens@mumc.nl
Caroline Van Durme, MD
- Recruiting
VieCuri Medisch Centrum
Venlo
Clinical Site
Tim Jansen, MD
About this study
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
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Read the detailed 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.
- Conditions
- Acute Gout Flare, Gout Attack, Gout Flare, Gouty Arthritis, Gout, Arthritis
- Being tested
- Dapansutrile, Placebo Tablet
- 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
- Medical subject headings
- Arthritis, Gouty, Gout, Arthritis, Arthralgia, Inflammation, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapansutrileDrug
Also called OLT1177
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 TabletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dapansutrile | Experimental | 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. Receives: Drug: Dapansutrile |
| Placebo Tablet | Placebo comparator | 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. Receives: Other: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (13)
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.
Measured: 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).
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".
Measured: 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)
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.
Measured: 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).
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".
Measured: 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.
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.
Measured: 48 and 72 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).
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.
Measured: 15 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.
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.
Measured: 4, 8 and 15 days
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
Measured: up to 15 days
Physical examinations
Physical examinations will be conducted to assess changes in subject health throughout the duration of the study.
Measured: Up to 15 days
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
Measured: Up to 15 days
Electrocardiograms
Electrocardiograms will be captured and analyzed for changes throughout the duration of the study.
Measured: 15 days
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
Measured: Up to 15 days
Adverse events
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.
Measured: Up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start6 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gout FlareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olatec Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658575
- Sponsor's protocol ID
- OLT1177-08
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No