Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Conditions

• Acute Gout Flare
• Arthritis
• Gout
• Gout Attack
• Gout Flare
• Gouty Arthritis
• Joint Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dapansutrile — 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 — 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

The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.

Key Dates

Start date

Jan 6, 2023

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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 Comparator: 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.

Primary Outcome Measure

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 [ Time Frame: 72 hours ]

Central Contacts

• Philip Piscitelli
  +1 833-652-8321
  [email protected]
• Clinical Operations
  [email protected]

Locations (25)

Find similar trials in Birmingham, AL

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