NCT05119686

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_2

Geographic Reach
3 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2022

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

October 20, 2021

Last Update Submit

May 6, 2023

Conditions

GoutArthritis, GoutyHyperuricemiaGout Chronic

Outcome Measures

Primary Outcomes (1)

  • Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing

    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

    6 weeks

Secondary Outcomes (5)

  • sUA levels < 5, < 4, and < 3 mg/dL

    6 weeks

  • Incidence of Adverse Events

    14 weeks

  • Maximum Observed Plasma Concentration (Cmax)

    12 weeks

  • Time to observed Cmax (Tmax)

    12 weeks

  • Area under the plasma concentration-time curve (AUC)

    12 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

AR882 Dose 1 x 12 weeks

Drug: AR882 Dose 1

Group 2

EXPERIMENTAL

AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks

Drug: AR882 Dose 1Drug: AR882 Dose 2

Group 3

PLACEBO COMPARATOR

AR882 matching placebo x 12 weeks

Drug: Placebo

Interventions

AR882 Dose 1DRUG

Solid Oral Capsule

Group 1Group 2
AR882 Dose 2DRUG

Solid Oral Capsule

Group 2
PlaceboDRUG

Matching Solid Oral Capsule Placebo

Group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Arthrosi Investigative Site

Gilbert, Arizona, 85297, United States

Location

Arthrosi Investigative Site

Sun City, Arizona, 85351, United States

Location

Arthrosi Investigative Site

Tucson, Arizona, 85704, United States

Location

Arthrosi Investigative Site

Miami, Florida, 33143, United States

Location

Arthrosi Investigative Site

Miami Lakes, Florida, 33014, United States

Location

Arthrosi Investigative Site

Tampa, Florida, 33613, United States

Location

Arthrosi Investigative Site

Honolulu, Hawaii, 96814, United States

Location

Arthrosi Investigative Site

Overland Park, Kansas, 66212, United States

Location

Arthrosi Investigative Site

Cleveland, Ohio, 44122, United States

Location

Arthrosi Investigative Site

Cleveland, Ohio, 44195, United States

Location

Arthrosi Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Arthrosi Investigative Site

Dallas, Texas, 75231, United States

Location

Arthrosi Investigative Site

Houston, Texas, 77074, United States

Location

Arthrosi Investigative Site

Tomball, Texas, 77375, United States

Location

Arthrosi Investigative Site

West Jordan, Utah, 84088, United States

Location

Arthrosi Investigative Site

Glendale, Wisconsin, 53217, United States

Location

Arthrosi Investigative Site

Melbourne, Camberwell, 3124, Australia

Location

Arthrosi investigative Site

Botany, New South Wales, 2019, Australia

Location

Arthrosi Investigative Site

Taichung, 402, Taiwan

Location

Arthrosi Investigative Site - 301

Taipei, 112, Taiwan

Location

Arthrosi Investigative Site - 304

Taipei, 112, Taiwan

Location

Arthrosi Investigative Site

Taipei, 114, Taiwan

Location

Arthrosi Investigative Site

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

GoutArthritis, GoutyHyperuricemia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • R Keenan, MD

    Arthrosi Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 15, 2021

Study Start

November 16, 2021

Primary Completion

November 17, 2022

Study Completion

November 17, 2022

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations

AU(2)US(16)TW(5)