Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
NCT ID: NCT04987294
Last Updated: 2023-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
19 participants
INTERVENTIONAL
2022-09-02
2022-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
ALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
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.
Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Interventions
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ALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Allena Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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C Tosone, MS, RAC
Role: STUDY_DIRECTOR
Allena Pharmaceuticals
Locations
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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
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
Countries
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Other Identifiers
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ALLN-346-202
Identifier Type: -
Identifier Source: org_study_id
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