Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
- Conditions
- HyperuricemiaGoutChronic Kidney Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT04987294
- Lead Sponsor
- Allena Pharmaceuticals
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALLN-346 (Engineered Urate Oxidase) ALLN-346 ALLN-346 is novel urate oxidase provided as capsules for oral administration. ALLN-346 will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days. Placebo Placebo Matching placebo capsules for oral administration. Placebo capsules will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days.
- Primary Outcome Measures
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAEs) 42 days Treatment emergent adverse events
- Secondary Outcome Measures
Name Time Method Serum Urate 14 Days Serum urate \[mg/dL\]
Trial Locations
- Locations (16)
Best Quality Research, Inc.
🇺🇸Hialeah, Florida, United States
Syed Research Consultants, LLC
🇺🇸Sheffield, Alabama, United States
Orthopedic Physicians Alaska
🇺🇸Anchorage, Alaska, United States
Allameh Medical Corporation
🇺🇸Mission Viejo, California, United States
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
New Generation of Medical Research
🇺🇸Hialeah, Florida, United States
The Center of Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Burke Primary Care
🇺🇸Morganton, North Carolina, United States
Elite Clinical Research, LLC
🇺🇸Jackson, Mississippi, United States
NY Total Medical Care, PC
🇺🇸Brooklyn, New York, United States
Summit research Group, LLC
🇺🇸Stow, Ohio, United States
Northeast Clinical Research Center, LLC
🇺🇸Bethlehem, Pennsylvania, United States
P&I Clinical Research, LLC
🇺🇸Lufkin, Texas, United States
Kendall South Medical Center, Inc.
🇺🇸Miami, Florida, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Briggs Clinical Research, LLC
🇺🇸San Antonio, Texas, United States