Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlatec Therapeutics LLC
About this trial
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
This trial does not accept healthy volunteersQualifiers
Male and female subjects age 18 or older
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dapansutrile
DrugAn 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
Other interventionAn 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: DapansutrileExperimental treatment 1 intervention
Group B: Placebo TabletPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
72 hoursSecondary outcomes
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.
Time frame
12, 24, 36, 48 and 60 hours; 8 and 15 days2
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".
Time frame
4 and 8 days3
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.
Time frame
8 and 15 days4
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".
Time frame
4 and 8 daysSponsors and contacts
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Source ClinicalTrials.gov