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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Diseases; Hyperuricemia; Gout
• Intervention / Treatment: Drug: Placebo; Drug: ALLN-346

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Muscle Shoals, Alabama, United States, 35661
      • Syed Research Consultants, LLC
    • Sheffield, Alabama, United States, 35660
      • Syed Research Consultants, LLC
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Orthopedic Physicians Alaska
  • California
    • Mission Viejo, California, United States, 92691
      • Allameh Medical Corporation
  • Florida
    • Hialeah, Florida, United States, 33016
      • New Generation of Medical Research
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.
    • Hialeah, Florida, United States, 33016
      • Best Quality Research, Inc.
    • Miami, Florida, United States, 33185
      • Kendall South Medical Center, Inc.
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center of Rheumatology and Bone Research
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Elite Clinical Research, LLC
  • New York
    • Brooklyn, New York, United States, 11215
      • NY total Medical Care, PC
  • North Carolina
    • Morganton, North Carolina, United States, 28655
      • Burke Primary Care
  • Ohio
    • Stow, Ohio, United States, 44224
      • Summit Research Group, LLC
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center, LLC
  • Texas
    • Lufkin, Texas, United States, 75904
      • P&I Clinical Research, LLC
    • San Antonio, Texas, United States, 78224
      • Briggs Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: ALLN-346; ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; Other Names: Engineered urate oxidase
Placebo Comparator: 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.	Drug: Placebo; Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules; Other Names: Matching placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs)	Treatment emergent adverse events	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Urate	Serum urate [mg/dL]	14 Days

Collaborators and Investigators

• Sponsor: Allena Pharmaceuticals
• Investigators: Study Director: C Tosone, MS, RAC, Allena Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia; Gout; Antirheumatic Agents; Gout Suppressants; Rasburicase
• Other Study ID Numbers: ALLN-346-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No