NCT05658575 Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
| NCT ID | NCT05658575 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Olatec Therapeutics, Inc. |
| Condition | Acute Gout Flare |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-01-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2023-01-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05658575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Gout Flare. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05658575 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05658575 currently recruiting?
Yes, NCT05658575 is actively recruiting participants. Contact the research team at phil.piscitelli@olatec.com for enrollment information.
Where is the NCT05658575 trial being conducted?
This trial is being conducted at Birmingham, United States, Glendale, United States, Mesa, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05658575 clinical trial?
NCT05658575 is sponsored by Olatec Therapeutics, Inc.. The trial plans to enroll 300 participants.