Acute gout flare MedDRA version: 20.0 Level: LLT Classification code 10018628 Term: Gout acute System Organ Class: 100000004861
Conditions
Interventions
Product Name: Dapansutrile Capsules
Product Code: OLT1177 Capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dapansutrile
Sponsors
Olatec Therapeutics LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female subjects between 18 and 80 years old, inclusive 2) Gout in a joint of a subject’s lower limbs (e.g. ankle, foot, knee, toe) as indicated by the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint and in accordance with ACR/EULAR 2015 Gout Classification Criteria 3) Confirmation of a gout flare in the target joint that began within 96 hours prior to the Baseline visit, based on presence of subject-reported joint pain at rest of = 50 mm on a 0 - 100 mm VAS and at least two of the following criteria in the target joint: a. Subject-reported flare b. Subject-reported warm joint c. Subject-reported swollen joint 4) Acceptable overall medical condition to be safely enrolled in and to complete the study (with specific regard to cardiovascular, renal and hepatic conditions) in the opinion of the Investigator 5) Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study, which includes abstaining from use of pain or Rescue Medication (for 12 hours after first dose of investigational drug) and other prohibited medications as outlined in Section 5.6.3 of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1) Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who: a. Are or intend to become pregnant (including use of fertility drugs) during the study b. Are nursing [female subjects only] c. Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. 2) Presence of an acute gout flare in more than one joint at the Baseline visit 3) Presence of another inflammatory arthritis in addition to gout 4) Presence or known history of other autoimmune conditions (e.g. systemic lupus erythematosus, hypophysitis, etc.) 5) 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, at the discretion of the Investigator 6) Use of any prohibited concomitant medications/therapies over the periods defined in Section 5.6.3 or planned use of any concomitant medications/therapies during the Treatment Period (including the use of paracetamol within 4 hours prior to the Baseline visit or other pain medications within 12 hours prior to the Baseline visit) 7) Active infection within 3 days prior to the Baseline visit 8) History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV) 9) Diagnosed with any form of internal cancer within the past 5 years 10) Any other concomitant medical or psychiatric conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing protocol requirements 11) History of alcohol or substance abuse within the 12 months prior to the Baseline visit 12) Enrollment in any trial and/or use of any investigational product or device within the immediate 30-day period prior to the Baseline visit 13) Enrollment in any study previously sponsored by Olatec Therapeutics LLC, specifically Study OLT1177-01, Study OLT1177-02, Study OLT1177-03 or Study OLT1177-04 14) Known diagnosis of chronic kidney disease or known history of renal impairment (e.g. calculated glomerular filtration rate [GFR] less than 40 mL/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of OLT1177 Capsule after oral administration in subjects with an acute gout flare; Secondary Objective: To assess the clinical activity of various doses of OLT1177 Capsule in treating signs and symptoms resulting from an acute gout flare To assess OLT1177-induced changes in inflammatory biomarkers ; Primary end point(s): The primary endpoints are those related to safety objective of the study, specifically: - Physical examination (abbreviated general and site specific examination) - Vital Signs (pulse, resting blood pressure, temperature, respiration rate) - Safety laboratory measures (chemistry, hematology and urinalysis) - Safety electrocardiograms (ECGs) - Adverse Events (AEs) during the clinical trial The primary clinical activity outcome will be: - Change in subject-reported pain intensity score from Baseline (Day 0) to Day 3 (evening; approximately 72 hours after the first dose) in the target joint (100-mm VAS) ; Timepoint(s) of evaluation of this end point: - Physical examination: Baseline (pre-dose), Day 14 - Vital Signs: Baseline (pre- and post-dose), Day 3, Day 7 and Day 14 - Safety laboratory measures: Baseline (pre-dose), Day 3, Day 7 and Day 14 - Safety electrocardiograms (ECGs): Baseline (pre-dose) and Day 7 • Adverse Events (AEs): throughout clinical trial • Change in subject-reported pain intensity score in the target joint (100-mm VAS): Baseline & Day 3 (evening) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The principle secondary clinical activity outcomes will be: - Subject-reported global evaluation of treatment at Day 7 (Likert scale) The following secondary clinical activity variables will also be collected: - Subject-reported pain intensity score in the target joint (100 mm-VAS) - Subject-reported general disability score in the target joint (100 mm-VAS) - Subject-reported walking disability score in the target joint (100 mm-VAS) - Investigator-assessed Index Joint Score (tenderness, swelling, erythema, warmth) - Investigator-assessed Global Rating of Disease (Likert scale) - Blood levels of high sensitivity C-reactive protein (hsCRP) and Serum Amyloid A protein (SAA) and inflammatory cytokines - If at any time during the study a subject is unable to tolerate his/her pain and wishes to receive standard medical intervention for an acute gout flare, the subject will be withdrawn from the study, considered a Treatment Failure and treated with either prednisolone (30 mg QD) or colchicine (0.5 mg TID). In addition to the clinical activity variables described above, the number and proportion of Treatment Failures in each cohort will be captured and summarized in the study results. ; Timepoint(s) of evaluation of this end point: - Subject-reported global evaluation of treatment (Likert scale): Day 7 - Subject-reported pain intensity, general disability and walking disability score in the target joint (100 mm-VAS): Baseline (pre-dose), 2, 4, 6 and 12 hours post-dose, twice per day on Days 1 - 7, and Day 14 - Investigator-assessed Index Joint Score & Investigator-assessed Global Rating of Disease (Likert scale): Baseline (pre- and post-dose), Day 3 and Day 7 - Blood levels of high sensitivity C-reactive protein (hsCRP), Serum Amyl | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials Inquiries
Olatec Therapeutics LLC
Outcome results
None listed