A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 19
- Locations
- 16
- Primary Endpoint
- Incidence of Treatment Emergent Adverse Events (TEAEs)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
ALLN-346 (Engineered Urate Oxidase)
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.
Intervention: ALLN-346 (Drug)
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: 42 days
Treatment emergent adverse events
Secondary Outcomes
- Serum Urate(14 Days)