Clinical trial NCT04987294: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hyperuricemia
Gout
Chronic Kidney Diseases
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 2:1 to receive ALLN-346 or placebo.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: 42 days
Secondary outcomes:
measure: Serum Urate
timeFrame: 14 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Muscle Shoals
country: United States
facility: Syed Research Consultants, LLC
state: Alabama
city: Sheffield
country: United States
facility: Syed Research Consultants, LLC
state: Alabama
city: Anchorage
country: United States
facility: Orthopedic Physicians Alaska
state: Alaska
city: Mission Viejo
country: United States
facility: Allameh Medical Corporation
state: California
city: Hialeah
country: United States
facility: Eastern Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: New Generation of Medical Research
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Wheaton
country: United States
facility: The Center of Rheumatology and Bone Research
state: Maryland
city: Jackson
country: United States
facility: Elite Clinical Research, LLC
state: Mississippi
city: Brooklyn
country: United States
facility: NY Total Medical Care, PC
state: New York
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Stow
country: United States
facility: Summit research Group, LLC
state: Ohio
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center, LLC
state: Pennsylvania
city: Lufkin
country: United States
facility: P&I Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Briggs Clinical Research, LLC
state: Texas
Study officials:
affiliation: Allena Pharmaceuticals
name: C Tosone, MS, RAC
role: STUDY_DIRECTOR
References: