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

Primary Purpose

Hyperuricemia, Gout, Chronic Kidney Diseases

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALLN-346
Placebo
Sponsored by
Allena Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham
  • Syed Research Consultants, LLC
  • Syed Research Consultants, LLC
  • Orthopedic Physicians Alaska
  • Allameh Medical Corporation
  • Eastern Research, Inc.
  • Best Quality Research, Inc.
  • New Generation of Medical Research
  • Kendall South Medical Center, Inc.
  • The Center of Rheumatology and Bone Research
  • Elite Clinical Research, LLC
  • NY Total Medical Care, PC
  • Burke Primary Care
  • Summit research Group, LLC
  • Northeast Clinical Research Center, LLC
  • P&I Clinical Research, LLC
  • Briggs Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALLN-346 (Engineered Urate Oxidase)

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events (TEAEs)
Treatment emergent adverse events

Secondary Outcome Measures

Serum Urate
Serum urate [mg/dL]

Full Information

First Posted
July 26, 2021
Last Updated
June 21, 2023
Sponsor
Allena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04987294
Brief Title
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Company Financing
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allena Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Gout, Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized 2:1 to receive ALLN-346 or placebo.
Masking
ParticipantInvestigator
Masking Description
Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALLN-346 (Engineered Urate Oxidase)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ALLN-346
Other Intervention Name(s)
Engineered urate oxidase
Intervention Description
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo capsule
Intervention Description
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Description
Treatment emergent adverse events
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Serum Urate
Description
Serum urate [mg/dL]
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Tosone, MS, RAC
Organizational Affiliation
Allena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Syed Research Consultants, LLC
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Syed Research Consultants, LLC
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Orthopedic Physicians Alaska
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Allameh Medical Corporation
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Eastern Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Best Quality Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
New Generation of Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
The Center of Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Elite Clinical Research, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
NY Total Medical Care, PC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Burke Primary Care
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Summit research Group, LLC
City
Stow
State/Province
Ohio
ZIP/Postal Code
44224
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
P&I Clinical Research, LLC
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Briggs Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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