Clinical trial NCT01265264 (phase 2, status: completed)
Conditions: gout, hyperuricemia, arthritis, joint disease
ICD codes: M10.9, M10.08, M10.00, M10.011, M10.012, M10.019, M10.021, E79.0, A01.04, A02.23, A39.83, A39.84, A54.42, B06.82, B26.85
Drugs: ulodesine, placebo
SMILES: OC[C@H]1CN(CC2=CNC3=C2N=CNC3=O)C[C@@H]1O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 to < 70 years

          -  Baseline sUA ≥ 6.0 mg/dL after at least 2 weeks of treatment on a stable 300 mg dose
             of allopurinol

          -  Documented diagnosis of gout according to the American Rheumatism Association
             --Preliminary Criteria for the Diagnosis of Gout

          -  Be willing and able to take colchicine 0.6 mg per day or naproxen 220-250 mg twice
             daily as prophylaxis for gout flares and, if needed, a single daily dose of a proton
             pump inhibitor to prevent gastrointestinal discomfort

          -  Female participants must:

               -  Be sexually abstinent

               -  Be surgically sterile

               -  Be postmenopausal or on stable contraception

          -  Male participants must:

               -  Be sexually abstinent

               -  Be > 1 year post-vasectomy

               -  Using condoms with spermicide with partners meeting female requirements

        Exclusion Criteria:

          -  Unable to tolerate 300 mg allopurinol

          -  Unable to tolerate both colchicine 0.6 mg per day and naproxen 220-250 mg twice daily

          -  Prior participation in a clinical study with BCX4208

          -  Gout flare during the Screening Period that is resolved for less than 2 weeks prior to
             first treatment with BCX4208 or placebo (exclusive of chronic synovitis/ arthritis)

          -  Unstable angina, symptomatic arrhythmia, signs or symptoms compatible with New York
             Heart Association Class III or Class IV heart failure, history of long QT syndrome, or
             QTc interval < 350 msec or > 475 msec

          -  Poorly controlled hypertension (SBP > 160 mmHg or DBP > 100 mmHG at Screening or
             Baseline)

          -  Moderate or severe renal impairment and/or calculated creatinine clearance of < 60
             mL/min(Cockroft-Gault method)

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > 2.0 x ULN

          -  CD4+ cell counts by flow cytometry < 500 cells/mm3

          -  Hemoglobin < 10 g/dL or > 18 g/dL males or < 10 g/dL or > 17 g/dL females White blood
             cell count < 3.7 x 109/L or > 11 x 109/L

          -  Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the
             next 4 months

          -  Positive serology for hepatitis B surface antigen or hepatitis C or HIV type 1

          -  Immunocompromised or on systemic immunosuppressive medications or antirheumatic drugs
             (including anakinra and adrenocorticotropic hormone)from Screening to Day 92

          -  Azathioprine or 6-mercaptopurine within 14 days of first dose of allopurinol
             Hydrochlorothiazide in doses > 50 mg per day from Screening to Day 92

          -  Use of herbal/dietary supplements Screening to Day 92

          -  Recipient of any live or attenuated vaccine within 6 weeks of Screening

          -  Uric acid-lowering drugs other than allopurinol from Screening to Day 92 Systemic
             corticosteroids within 4 weeks prior to Day 1 (this does not include pulmonary or
             nasal inhaler containing corticosteroids, ophthalmic corticosteroids, joint
             injections, or low potency topical steroids)

          -  Investigational drug within 30 days prior to signing the ICF for this study

          -  Clinically significant and relevant drug allergies

          -  Chronic or recurrent infections (≥ 3 infections at the same site within 12 months)

          -  Cancer within 12 months-Except non-melanomatous localized skin cancer or completely
             excised and cured carcinoma-in-situ of uterine cervix or subjects who were previously
             treated for prostate or breast cancer if they currently are stable and have not been
             on chemo therapy within the last year prior to screening.

          -  Alcohol or drug abuse within 12 months of signing the ICF, or current substance
             dependence or abuse

          -  Other medical conditions which, in the opinion of the PI, would jeopardize the safety
             of the study subject or impact the validity of the study results.