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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
1 other identifier
interventional
19
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2022
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2022
CompletedJune 23, 2023
June 1, 2023
Same day
July 26, 2021
June 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Treatment emergent adverse events
42 days
Secondary Outcomes (1)
Serum Urate
14 Days
Study Arms (2)
ALLN-346 (Engineered Urate Oxidase)
EXPERIMENTALALLN-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.
Placebo
PLACEBO COMPARATORMatching 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.
Interventions
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Syed Research Consultants, LLC
Muscle Shoals, Alabama, 35661, United States
Syed Research Consultants, LLC
Sheffield, Alabama, 35660, United States
Orthopedic Physicians Alaska
Anchorage, Alaska, 99508, United States
Allameh Medical Corporation
Mission Viejo, California, 92691, United States
Eastern Research, Inc.
Hialeah, Florida, 33013, United States
Best Quality Research, Inc.
Hialeah, Florida, 33016, United States
New Generation of Medical Research
Hialeah, Florida, 33016, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
The Center of Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Elite Clinical Research, LLC
Jackson, Mississippi, 39202, United States
NY Total Medical Care, PC
Brooklyn, New York, 11215, United States
Burke Primary Care
Morganton, North Carolina, 28655, United States
Summit research Group, LLC
Stow, Ohio, 44224, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017, United States
P&I Clinical Research, LLC
Lufkin, Texas, 75904, United States
Briggs Clinical Research, LLC
San Antonio, Texas, 78224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
C Tosone, MS, RAC
Allena Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 3, 2021
Study Start
September 2, 2022
Primary Completion
September 2, 2022
Study Completion
September 2, 2022
Last Updated
June 23, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share