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

Sponsor

Allena Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04987294

Collaborator

(none)

Enrollment

Locations

Arms

10.9

Anticipated Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomized 2:1 to receive ALLN-346 or placebo.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 :

Aug 31, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

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 Names: 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 Names: Matching placebo capsule

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 Names:

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 Names:

Matching placebo capsule

Outcome Measures

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events (TEAEs) [42 days]
Treatment emergent adverse events

Secondary Outcome Measures

Serum Urate [14 Days]
Serum urate [mg/dL]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Syed Research Consultants, LLC	Muscle Shoals	Alabama	United States	35661
3	Syed Research Consultants, LLC	Sheffield	Alabama	United States	35660
4	Orthopedic Physicians Alaska	Anchorage	Alaska	United States	99508
5	Allameh Medical Corporation	Mission Viejo	California	United States	92691
6	Eastern Research, Inc.	Hialeah	Florida	United States	33013
7	Best Quality Research, Inc.	Hialeah	Florida	United States	33016
8	New Generation of Medical Research	Hialeah	Florida	United States	33016
9	Kendall South Medical Center, Inc.	Miami	Florida	United States	33185
10	The Center of Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
11	Elite Clinical Research, LLC	Jackson	Mississippi	United States	39202
12	NY Total Medical Care, PC	Brooklyn	New York	United States	11215
13	Burke Primary Care	Morganton	North Carolina	United States	28655
14	Summit research Group, LLC	Stow	Ohio	United States	44224
15	Northeast Clinical Research Center, LLC	Bethlehem	Pennsylvania	United States	18017
16	P&I Clinical Research, LLC	Lufkin	Texas	United States	75904
17	Briggs Clinical Research, LLC	San Antonio	Texas	United States	78224

Sponsors and Collaborators

Allena Pharmaceuticals

Investigators

Study Director: C Tosone, MS, RAC, Allena Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allena Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04987294

Other Study ID Numbers:

ALLN-346-202

First Posted:

Aug 3, 2021

Last Update Posted:

Dec 6, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gout

Kidney Diseases

Renal Insufficiency, Chronic

Hyperuricemia

Rasburicase

Study Results

No Results Posted as of Dec 6, 2021