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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05658575
Other study ID # OLT1177-08
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 6, 2023
Est. completion date October 2024

Study information

Verified date April 2024
Source Olatec Therapeutics LLC
Contact Mustafa Noor, MD, FACP
Phone +1 833-652-8321
Email mustafa.noor@olatec.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
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.
Other:
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.

Locations

Country Name City State
France Hôpital Lariboisière Paris
France CHU de Rouen - Hôpital Charles-Nicolle Rouen
Spain Hospital general Universitario Dr. Balmis Alicante
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Universitario Infanta Leonor Madrid
United States Amarillo Center of Clinical Research Amarillo Texas
United States University of Michigan Ann Arbor Michigan
United States University of Alabama at Birmingham Birmingham Alabama
United States Clinical Trial Site Bothell Washington
United States Great Lakes Clinical Trials Chicago Illinois
United States Omega Research DeBary Florida
United States Hillcrest Medical Research DeLand Florida
United States Altoona Research Duncansville Pennsylvania
United States Arthritis Center of North Georgia - Gainesville Gainesville Georgia
United States Arizona Arthritis & Rheumatology Associates - Glendale Glendale Arizona
United States University of Florida Health Jacksonville Jacksonville Florida
United States The Research Group of Lexington Lexington Kentucky
United States American Institute of Research Los Angeles California
United States Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa Mesa Arizona
United States Well Pharma Medical Research Miami Florida
United States Montana Medical Research Missoula Montana
United States IMA Clinical Research - Manhattan New York New York
United States NYU Langone New York New York
United States Clinical Trial Site Orland Park Illinois
United States Utah Health - University of Utah Hospital Salt Lake City Utah
United States TriWest Research Associates San Diego California
United States Arthritis Northwest Spokane Washington
United States Lower Country Rheumatology - Summerville Summerville South Carolina
United States Clinical Research of West Florida Tampa Florida
United States Valiance Clinical Research - Tarzana Tarzana California
United States Clinical Trial Site Thomasville Georgia

Sponsors (1)

Lead Sponsor Collaborator
Olatec Therapeutics LLC

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 72 hours
Secondary 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. 12, 24, 36, 48 and 60 hours; 8 and 15 days
Secondary 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". 4 and 8 days
Secondary 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. 8 and 15 days
Secondary 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". 4 and 8 days
Secondary To further assess the clinical activity of dapansutrile compared to placebo in reducing joint pain at scheduled time points post initial loading dose of IMP. Proportion of subjects with a response (defined as a 20%, 50%, or 70% reduction from baseline without using Rescue Medication) in the subject-assessed pain intensity score (100-mm VAS) in the target joint up to Day 15 post initial loading dose of study drug. 48 and 72 hours; 8 and 15 days
Secondary 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 subject-assessed Quality of Life (QoL) questionnaire Short Form Health Survey-12 version 2.0 (SF-12v2) at scheduled assessments through Study Day 15. 15 days
Secondary To further assess the clinical activity of dapansutrile compared to placebo in reducing joint pain at scheduled time points 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 any actively flaring non-target joint(s) 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. 4, 8 and 15 days
Secondary To characterize the population PK of dapansutrile and exposure-response relationship for efficacy and safety. Blood samples will be drawn and analyzed in order to characterize the population PK of dapansutrile up to 15 days
Secondary Physical examinations Physical examinations will be conducted to assess changes in subject health throughout the duration of the study. Up to 15 days
Secondary Vital signs Vital signs consisting of pulse, resting blood pressure, temperature and respirations will be recorded and analyzed for changes throughout the duration of the study Up to 15 days
Secondary Electrocardiograms Electrocardiograms will be captured and analyzed for changes throughout the duration of the study. 15 days
Secondary Safety laboratory measurements Blood samples will be drawn and analyzed for routine chemistry blood markers, routine hematology/complete blood count and routine urinalysis will be performed throughout the duration of the study Up to 15 days
Secondary Adverse events Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event. Up to 36 days
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