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

TERMINATEDPHASE2

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

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

NCT04987294•Allena Pharmaceuticals

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (17)

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

Key Dates

Start Date

September 2, 2022

Primary Completion Date

September 2, 2022

Completion Date

September 2, 2022

Last Updated

June 23, 2023

Enrollment

ACTUAL participants

Conditions

HyperuricemiaGoutChronic Kidney Diseases

Interventions

ALLN-346

DRUG

Placebo

DRUG

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Gout

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RECRUITINGEARLY_PHASE1

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Chronic Kidney DiseasesCalciphylaxis+4 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Dotinurad Versus Allopurinol in Participants With Gout

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