What this study is
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
What's being tested
- Dapansutrile
Intervention · DRUG
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
Intervention · OTHER
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 details
- 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
- Sponsor
- Olatec Therapeutics LLC
- Conditions
- Acute Gout Flare · Gout Attack · Gout Flare · Gouty Arthritis · Gout · Arthritis · Joint Pain
- Enrolling
- 300 people
- Starts
- 2023-01-06
- Est. completion
- 2027-01-31
- Design
- Double-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (40)
30 openArizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, United States
- Rebecca Martinez · Contact480-350-7655rebecca.martinez@azarthritis.com
- Mona Amin, MD · Principal investigator
RecruitingArizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, Arizona, United States
- Rebecca 480-350-7655 · Contact480-350-7655rebecca.martinez@azarthritis.com
- Swati Bharadwaj, MD · Principal investigator
RecruitingTriWest Research Associates
San Diego, California, United States
- Lennette Fontelar · Contact619-334-4735lfontelar@triwestresearch.com
- Arthur Ray Mabaquiao, MD · Principal investigator
RecruitingValiance Clinical Research - Tarzana
Tarzana, California, United States
- Gail Ma · Contact818-938-9167g.ma@valianceclinicalresearch.com
- Richard Park, MD · Principal investigator
RecruitingHillcrest Medical Research
DeLand, Florida, United States
- Larry Moulder · Contact321-999-7616lmoulder@hillcrestmedicalresearch.com
- John Hill, MD · Principal investigator
RecruitingSIMEDHealth
Gainesville, Florida, United States
- Brandy Donahue-Quails · Contact352-333-3885Bdonahue-quails@simedresearch.com
- Timothy H Elder, MD · Principal investigator
RecruitingUniversity of Florida Health Jacksonville
Jacksonville, Florida, United States
- Shannon Lloyd · Contact904-633-0071shannon.lloyd@ufhealth.org
- Gurjit Kaeley, MD · Principal investigator
RecruitingWell Pharma Medical Research
Miami, Florida, United States
- Ramon Perez Landaburo · Contact305-665-4818 ext. 231rperez@wpharma.com
- Eddie Armas, MD · Principal investigator
RecruitingClinical Research of West Florida
Tampa, Florida, United States
- Jocelyn Evans · Contact813-870-1292 ext. 129jevans@crwf.com
- Lon Lynn, MD · Principal investigator
RecruitingArthritis Center of North Georgia - Gainesville
Gainesville, Georgia, United States
- Cindy Valenzuela · Contact770-531-3711cvalenzuela@southeasternra.com
- Brent Flickinger, MD · Principal investigator
RecruitingAdvanced Quality Medical Research
Orland Park, Illinois, United States
- Selahaddin Hocaoglu · Contact312-823-6800selahaddin@m1-health.com
- Dennis Levinson, MD · Principal investigator
RecruitingMontana Medical Research
Missoula, Montana, United States
- Eve Hickey · Contact406-549-1124ehickey@montanamedicalresearch.com
- Clancy Cone, MD · Principal investigator
RecruitingLower Country Rheumatology - Summerville
Summerville, South Carolina, United States
- Eleanor Gardzalla · Contact843-572-4840egardzalla@articularishealthcare.com
- Jennifer Murphy, MD · Principal investigator
RecruitingAmarillo Center of Clinical Research
Amarillo, Texas, United States
- Vallen White · Contact806-352-2453vwhite@allergyarts.com
- Constantine Saadeh, MD · Principal investigator
RecruitingUtah Health - University of Utah Hospital
Salt Lake City, Utah, United States
- Julieanne Hall · Contact801-213-1558julieanne.hall@hsc.utah.edu
- Naomi Schlessinger, MD · Principal investigator
RecruitingArthritis Northwest
Spokane, Washington, United States
- Terri Cone · Contact509-838-6500tcone@arthritisnw.com
- Christopher Wright, MD · Principal investigator
RecruitingUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
WithdrawnAmerican Institute of Research
Los Angeles, California, United States
WithdrawnGreat Lakes Clinical Trials
Chicago, Illinois, United States
WithdrawnThe Research Group of Lexington
Lexington, Kentucky, United States
Active, not recruitingUniversity of Michigan
Ann Arbor, Michigan, United States
WithdrawnNYU Langone
New York, New York, United States
Active, not recruitingIMA Clinical Research - Manhattan
New York, New York, United States
WithdrawnAltoona Research
Duncansville, Pennsylvania, United States
WithdrawnClinical Trial Site
Bothell, Washington, United States
Withdrawn
15 sites outside the US
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
Bordeaux, France
- Clinical Contact · Contact
- Marie-Elise Truchetet, MD · Principal investigator
RecruitingHôpital Saint Philibert
Lomme, France
- Clinical Contact · Contact
- Tristan Pascart, MD · Principal investigator
RecruitingHôpital Lariboisière
Paris, France
- Clinical Contact · Contact
RecruitingCHU de Rouen - Hôpital Charles-Nicolle
Rouen, France
- Clinical Contact · Contact
RecruitingEmek Medical Center
Afula, Israel
- Clinical Contact · Contact
- Amir Bieber, MD · Principal investigator
RecruitingCarmel Medical Center
Haifa, Israel
- Noga Cohen · Contact(+972)5240434341nogacoh@clalit.org.il
- Devy Zisman, MD · Principal investigator
RecruitingRabin Medical Center - Beilinson and Hasharon
Petah Tikva, Israel
- Yosra Khateb · Contact(+972)39377105yusrakha@clalit.org.il
- Elisheva Pokroy-Shapira, MD · Principal investigator
RecruitingThe Chaim Sheba Medical Center
Ramat Gan, Israel
- Revital Nawi · Contact(+972)526668127revital.nawi@sheba.health.gov.il
- Howard Amital, MD · Principal investigator
RecruitingReade Research BV
Amsterdam, Netherlands
- Clinical Contact · Contact
- Martijn Gerritsen, MD · Principal investigator
RecruitingMaastricht Universitair Medisch Centrum
Maastricht, Netherlands
- Christel Mertens · Contact(+31)0433072099christel.mertens@mumc.nl
- Caroline Van Durme, MD · Principal investigator
RecruitingVieCuri Medisch Centrum
Venlo, Netherlands
- Clinical Site · Contact
- Tim Jansen, MD · Principal investigator
RecruitingHospital de la Santa Creu i Sant Pau
Barcelona, Spain
- Júlia Bernárdez · Contact(+34)935537112JBernardez@santpau.cat
- Cesar Diaz Torne, MD · Principal investigator
RecruitingHospital Universitario de La Princesa
Madrid, Spain
- Helena Vazquez · Contact(+34)915202473helena.vazquez@salud.madrid.org
- Esther Vicente Rabaneda, MD · Principal investigator
RecruitingHospital Universitario Infanta Leonor
Madrid, Spain
- Pedro Torres · Contact(+34)676146368pedro.a.torresgomez.sc@gmail.com
- Enrique Calvo Aranda, MD · Principal investigator
RecruitingHospital Universitario san Juan de Alicante
Alicante, Spain
Withdrawn
Study team
Sponsor
Olatec Therapeutics LLC
Study ID OLT1177-08
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.