Acute gout flare Gout
Conditions
Interventions
OLT1177 Capsule (100 mg each) will be self-administered for the duration of the
Treatment Period beginning at the Baseline visit and will continue through the
Day 7 visit. Investigational product wi
Acute gout flare
Gout
OLT1177
urate
Sponsors
Olatec Therapeutics LLC
Eligibility
Age
18 Years to 64 Years
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 visual analog scale (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.
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. See Section 5.6.2 for more details on acceptable forms of contraceptives. 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 |
|---|---|
| The primary clinical activity outcome will be the 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| The principle secondary clinical activity outcomes will be the subject-reported global evaluation of treatment at Day 7 (Likert scale). Additionally the following secondary clinical activity variables will 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), 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 Safety variables collected in the study will be: • 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 | — |
Countries
The Netherlands
Outcome results
None listed