NCT04987294

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Allena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hyperuricemia
• Gout
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	ALLN-346	ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
DRUG	Placebo	Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules

Timeline

• Start date: 2022-09-02
• Primary completion: 2022-09-02
• Completion: 2022-09-02
• First posted: 2021-08-03
• Last updated: 2023-06-23

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study