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

• Status: Recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allena Pharmaceuticals
• Treatments: Rasburicase

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