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Trial record 2 of 2 for:    ALLN-346 | Phase 2

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

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ClinicalTrials.gov Identifier: NCT04987294
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : December 6, 2021
Information provided by (Responsible Party):
Allena Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hyperuricemia Gout Chronic Kidney Diseases Drug: ALLN-346 Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized 2:1 to receive ALLN-346 or placebo.
Masking: Double (Participant, Investigator)
Masking Description: Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout

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 Name: 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 Name: Matching placebo capsule

Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 42 days ]
    Treatment emergent adverse events

Secondary Outcome Measures :
  1. Serum Urate [ Time Frame: 14 Days ]
    Serum urate [mg/dL]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04987294

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Contact: B Kandinov, PhD (617) 467-4577 Clinical346@allenapharma.com

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Stephanie Clark, RN    205-934-1444    sbiggers@uabmc.edu   
Syed Research Consultants, LLC Recruiting
Muscle Shoals, Alabama, United States, 35661
Contact: Loren McCoy, MD         
Syed Research Consultants, LLC Recruiting
Sheffield, Alabama, United States, 35660
Contact: Aaron Karr, MD         
United States, Alaska
Orthopedic Physicians Alaska Recruiting
Anchorage, Alaska, United States, 99508
Contact: John Botson, MD         
United States, California
Allameh Medical Corporation Recruiting
Mission Viejo, California, United States, 92691
Contact: Reza Azadegan       Research@DrAllameh.com   
United States, Florida
Eastern Research, Inc. Recruiting
Hialeah, Florida, United States, 33013
Contact: Ana Martinez       easternresearch.am@aol.com   
Best Quality Research, Inc. Recruiting
Hialeah, Florida, United States, 33016
Contact: Rudolfo Gutierrez-Alsina, MD         
New Generation of Medical Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Karelia Ruiz, MD         
Kendall South Medical Center, Inc. Recruiting
Miami, Florida, United States, 33185
Contact: Rafael Chiong, MD         
United States, Maryland
The Center of Rheumatology and Bone Research Recruiting
Wheaton, Maryland, United States, 20902
Contact: Jeffrey A Pottter, MD    301-942-6610    jap.crbr@gmail.com   
United States, Mississippi
Elite Clinical Research, LLC Recruiting
Jackson, Mississippi, United States, 39202
Contact: Christina Barlow, MD         
United States, New York
NY Total Medical Care, PC Recruiting
Brooklyn, New York, United States, 11215
Contact: Jorge Serje, MD         
United States, North Carolina
Burke Primary Care Recruiting
Morganton, North Carolina, United States, 28655
Contact: Stephen Smith, MD         
United States, Ohio
Summit research Group, LLC Recruiting
Stow, Ohio, United States, 44224
Contact: Scott Rigby, MD         
United States, Pennsylvania
Northeast Clinical Research Center, LLC Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Nelson Kopyt, DO         
United States, Texas
P&I Clinical Research, LLC Recruiting
Lufkin, Texas, United States, 75904
Contact: Vickie Jones, LVN/CRN    936-465-9533    vjones@piclinicalresearch.com   
Briggs Clinical Research, LLC Recruiting
San Antonio, Texas, United States, 78224
Contact: Raul Gaona, Sr., MD         
Sponsors and Collaborators
Allena Pharmaceuticals
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Study Director: C Tosone, MS, RAC Allena Pharmaceuticals
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Responsible Party: Allena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04987294    
Other Study ID Numbers: ALLN-346-202
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents