Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease

Launched by ALLENA PHARMACEUTICALS · Jul 26, 2021

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• 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