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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hyperuricemia, Gout, Chronic Kidney Diseases

In brief

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.

Key facts

Study ID

NCT04987294

Run by

Allena Pharmaceuticals

People needed

19

Starts

2022-09-02

Expected to finish

2022-09-02

Last updated by the study team

2023-06-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Burke Primary Care — Morganton, North Carolina, 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
• Briggs Clinical Research, LLC — San Antonio, Texas, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Syed Research Consultants, LLC — Muscle Shoals, Alabama, 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
• Best Quality Research, Inc. — Hialeah, Florida, United States
• New Generation of Medical Research — Hialeah, Florida, United States
• Kendall South Medical Center, Inc. — Miami, Florida, United States
• The Center of Rheumatology and Bone Research — Wheaton, Maryland, United States
• Elite Clinical Research, LLC — Jackson, Mississippi, United States
• NY Total Medical Care, PC — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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