ACTIVE_NOT_RECRUITING

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

Talk to us

Conditions

GoutArthritis, GoutyHyperuricemiaGout Chronic

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 months

Official Title

A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout

Quick Facts

Study Start:2025-03-11
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06846515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of gout
  2. * Occurrence of ≥ 2 self-reported gout flares in the last 12 months
  3. * Body weight no less than 50 kg
  4. * Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
  5. * Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
  6. * Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min
  1. * Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
  2. * Pregnant or breastfeeding
  3. * History of symptomatic kidney stones within the past 6 months

Contacts and Locations

Principal Investigator

Robert Keenan, MD
STUDY_DIRECTOR
Arthrosi Therapeutics, Inc.

Study Locations (Sites)

Arthrosi Investigative Site (620)
Birmingham, Alabama, 35215
United States
Arthrosi Investigative Site (616)
Huntsville, Alabama, 35801
United States
Arthrosi Investigative Site (680)
Peoria, Arizona, 85381
United States
Arthrosi Investigative Site (640)
Phoenix, Arizona, 85018
United States
Arthrosi Investigative Site (617)
Little Rock, Arkansas, 72205
United States
Arthrosi Investigative Site (614)
Garden Grove, California, 92844
United States
Arthrosi Investigative Site (618)
La Mesa, California, 91942
United States
Arthrosi Investigative Site (687)
La Mesa, California, 91942
United States
Arthrosi Investigative Site (655)
La Palma, California, 90623
United States
Arthrosi Investigative Site (632)
Lincoln, California, 95648
United States
Arthrosi Investigative Site (605)
Lomita, California, 90717
United States
Arthrosi Investigative Site (675)
Long Beach, California, 90806
United States
Arthrosi Investigative Site (603)
Santa Monica, California, 90404
United States
Arthrosi Investigative Site (672)
Tarzana, California, 91356
United States
Arthrosi Investigative Site (656)
Thousand Oaks, California, 91360
United States
Arthrosi Investigative Site (660)
Aurora, Colorado, 80012
United States
Arthrosi Investigative Site (669)
Colorado Springs, Colorado, 80909
United States
Arthrosi Investigative Site (612)
Fort Collins, Colorado, 80528
United States
Arthrosi Investigative Site (665)
Cooper City, Florida, 33024
United States
Arthrosi Investigative Site (613)
Jupiter, Florida, 33458
United States
Arthrosi Investigative Site (611)
Miami, Florida, 33173
United States
Arthrosi Investigative Site (644)
Miami, Florida, 33176
United States
Arthrosi Investigative Site (694)
Palmetto Bay, Florida, 33157
United States
Arthrosi Investigative Site (615)
Sanford, Florida, 32771
United States
Arthrosi Investigative Site (600)
Tampa, Florida, 33609
United States
Arthrosi Investigative Site (673)
Atlanta, Georgia, 30329
United States
Arthrosi Investigative Site (682)
Lilburn, Georgia, 30047
United States
Arthrosi Investigative Site (652)
Marietta, Georgia, 30060
United States
Arthrosi Investigative Site (658)
Honolulu, Hawaii, 96814
United States
Arthrosi Investigative Site (676)
Boise, Idaho, 83713
United States
Arthrosi Investigative Site (634)
Meridian, Idaho, 83642
United States
Arthrosi Investigative Site (657)
Chicago, Illinois, 60602
United States
Arthrosi Investigative Site (648)
Melrose Park, Illinois, 60160
United States
Arthrosi Investigative Site (678)
Indianapolis, Indiana, 46202
United States
Arthrosi Investigative Site (679)
Overland Park, Kansas, 66209
United States
Arthrosi Investigative Site (674)
Louisville, Kentucky, 40205
United States
Arthrosi Investigative Site (627)
Mandeville, Louisiana, 70471
United States
Arthrosi Investigative Site (650)
New Orleans, Louisiana, 70115
United States
Arthrosi Investigative Site (641)
Prairieville, Louisiana, 70769
United States
Arthrosi Investigative Site (662)
Oxon Hill, Maryland, 20745
United States
Arthrosi Investigative Site (653)
Rockville, Maryland, 20852
United States
Arthrosi Investigative Site (636)
Fall River, Massachusetts, 02721
United States
Arthrosi Investigative Site (622)
Bay City, Michigan, 48706
United States
Arthrosi Investigative Site (628)
Farmington Hills, Michigan, 48334
United States
Arthrosi Investigative Site (645)
Southfield, Michigan, 48076
United States
Arthrosi Investigative Site (633)
Gulfport, Mississippi, 39503
United States
Arthrosi Investigative Site (635)
Jackson, Mississippi, 39202
United States
Arthrosi Investigative Site (693)
Olive Branch, Mississippi, 38654
United States
Arthrosi Investigative Site (637)
Springfield, Missouri, 65807
United States
Arthrosi Investigative Site (626)
Town and Country, Missouri, 63017
United States
Arthrosi Investigative Site (664)
Missoula, Montana, 59808
United States
Arthrosi Investigative Site (610)
Lincoln, Nebraska, 68516
United States
Arthrosi Investigative Site (684)
Omaha, Nebraska, 68114
United States
Arthrosi Investigative Site (651)
Omaha, Nebraska, 68144
United States
Arthrosi Investigative Site (686)
Las Vegas, Nevada, 89102
United States
Arthrosi Investigative Site (661)
Brooklyn, New York, 11215
United States
Arthrosi Investigative Site (663)
Hartsdale, New York, 10530
United States
Arthrosi Investigative Site (625)
Charlotte, North Carolina, 28207
United States
Arthrosi Investigative Site (681)
Charlotte, North Carolina, 28277
United States
Arthrosi Investigative Site (683)
Raleigh, North Carolina, 27607
United States
Arthrosi Investigative Site (649)
Shelby, North Carolina, 28150
United States
Arthrosi Investigative Site (666)
Fargo, North Dakota, 58104
United States
Arthrosi Investigative Site (671)
Mason, Ohio, 45040
United States
Arthrosi Investigative Site (631)
Norman, Oklahoma, 73072
United States
Arthrosi Investigative Site (642)
Tulsa, Oklahoma, 74133
United States
Arthrosi Investigative Site (647)
Horsham, Pennsylvania, 19044
United States
Arthrosi Investigative Site (623)
Philadelphia, Pennsylvania, 19107
United States
Arthrosi Investigative Site (638)
Charleston, South Carolina, 29407
United States
Arthrosi Investigative Site (604)
Fort Mill, South Carolina, 29707
United States
Arthrosi Investigative Site (608)
North Charleston, South Carolina, 29405
United States
Arthrosi Investigative Site (619)
Chattanooga, Tennessee, 37404
United States
Arthrosi Investigative Site (624)
Hendersonville, Tennessee, 37075
United States
Arthrosi Investigative Site (670)
Amarillo, Texas, 79106
United States
Arthrosi Investigative Site (677)
Austin, Texas, 78735
United States
Arthrosi Investigative Site (690)
Dallas, Texas, 75251
United States
Arthrosi Investigative Site (639)
DeSoto, Texas, 75115
United States
Arthrosi Investigative Site (601)
Houston, Texas, 77074
United States
Arthrosi Investigative Site (688)
Plano, Texas, 75024
United States
Arthrosi Investigative Site (689)
Prosper, Texas, 75078
United States
Arthrosi Investigative Site (607)
Sugar Land, Texas, 77479
United States
Arthrosi Investigative Site (646)
Tomball, Texas, 77375
United States
Arthrosi Investigative Site (659)
Tomball, Texas, 77375
United States
Arthrosi Investigative Site (643)
Clinton, Utah, 84015
United States
Arthrosi Investigative Site (609)
Salt Lake City, Utah, 84121
United States
Arthrosi Investigative Site (654)
Salt Lake City, Utah, 84124
United States
Arthrosi Investigative Site (606)
Charlottesville, Virginia, 29911
United States
Arthrosi Investigative Site (691)
Winchester, Virginia, 22601
United States
Arthrosi Investigative Site (685)
Bellevue, Washington, 98004
United States
Arthrosi Investigative Site (668)
Kenosha, Wisconsin, 53144
United States

Collaborators and Investigators

Sponsor: Arthrosi Therapeutics

  • Robert Keenan, MD, STUDY_DIRECTOR, Arthrosi Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-11
Study Completion Date2026-04

Study Record Updates

Study Start Date2025-03-11
Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

  • Gout
  • Arthritis, Gouty
  • Hyperuricemia
  • Gout Chronic