Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05119686

Enrollment

140

Registered

2021-11-15

Start date

2021-11-16

Completion date

2022-11-17

Last updated

2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Gouty, Gout, Gout Chronic, Hyperuricemia

Brief summary

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.

Interventions

DRUGAR882 Dose 2

Solid Oral Capsule

DRUGPlacebo

Matching Solid Oral Capsule Placebo

DRUGAR882 Dose 1

Solid Oral Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* History of gout * sUA \> 7 mg/dL * Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2

Exclusion criteria

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * History of cardiac abnormalities * History of kidney stones

Design outcomes

Primary

Measure	Time frame	Description
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing	6 weeks	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL following 6 weeks of dosing

Secondary

Measure	Time frame	Description
sUA levels < 5, < 4, and < 3 mg/dL	6 weeks	Comparison of the treatment groups for proportion of patients whose sUA levels are \< 5, \< 4, and \< 3 mg/dL
Incidence of Adverse Events	14 weeks	Treatment Emergent Adverse Events and Serious Adverse Event incidence.
Maximum Observed Plasma Concentration (Cmax)	12 weeks	Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.
Time to observed Cmax (Tmax)	12 weeks	Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.
Area under the plasma concentration-time curve (AUC)	12 weeks	Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.

Countries

Australia, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026