Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Olatec Therapeutics

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Gouty Arthritis; Gout Attack; Arthritis; Joint Pain; Gout Flare; Gout; Acute Gout Flare

Treatments: Drug: Dapansutrile; Other: Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05658575

OLT1177-08

Details and patient eligibility

About

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

Full 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 Screening/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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects age 18 or older
• Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria:

A) For newly presenting subjects: 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) For previously diagnosed subjects: Confirmation of gout diagnosis as per criterion 2a OR history of gout diagnosis per one of the following: a. Documented history of the presence of MSU crystals in synovial fluid from the target joint or bursa ; or b. Historical imaging report of urate deposition in the target joint or bursa in their medical record5; or c. 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Dapansutrile

Experimental group

Description:

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.

Treatment:

Drug: Dapansutrile

Placebo Tablet

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Tablet