Chronic Kidney Diseases, Gout, Hyperuricemia
Conditions
Brief summary
The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.
Detailed description
This is a randomized, double-blind, placebo-controlled parallel group, multi-center phase II clinical study or orally administered ALLN-346 in subjects with hyperuricemia, gout and mild to moderate chronic kidney disease over a two-week period. Subjects will be enrolled in two cohorts based on estimated glomerular filtration rate (eGFR).
Interventions
DRUGALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
DRUGPlacebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Sponsors
Allena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment
Intervention model description
Subjects will be randomized 2:1 to receive ALLN-346 or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age 18 to 70 years * Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia) * Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout * Screening eGFR of ≥60 - \<90 mL/minute/1.73 m2 for Cohort A and ≥30 - \<60 mL/minute/1.73 m2 for Cohort B. * Concomitant medications stable for a minimum of 4 weeks prior to and during Screening * Body Mass Index (BMI) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening * Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
Exclusion criteria
* Currently taking any oral urate-lowering medication within 2 weeks prior to Screening * Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase * Gout flare requiring treatment within 14 days prior to or during Screening * Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening * History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening * Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening * Prior dosing in ALLN-346 clinical study * Per Investigator judgment, is not an ideal clinical study candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | 42 days | Treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Urate | 14 Days | Serum urate \[mg/dL\] |
Countries
United States
Outcome results
None listed