Gout Clinical Trial
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
| NCT number | NCT06439602 |
| Other study ID # | AR882-302 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | June 2024 |
| Est. completion date | November 2026 |
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
| Status | Recruiting |
| Enrollment | 750 |
| Est. completion date | November 2026 |
| Est. primary completion date | November 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - History of gout - Occurrence of = 2 self-reported gout flares in the last 12 months - Body weight no less than 50 kg - Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA = 7 mg/dL - Patients who are on medically appropriate ULT must have sUA > 6 mg/dL - Serum creatinine must be < 3.0 mg/dL and estimated CLcr = 30 mL/min Exclusion Criteria: - Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin - Pregnant or breastfeeding - History of symptomatic kidney stones within the past 6 months |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Arthrosi Investigative Site (203) | Botany | New South Wales |
| Australia | Arthrosi Investigative Site (200) | Camberwell | Victoria |
| Australia | Arthrosi Investigative Site (201) | Westmead | New South Wales |
| New Zealand | Arthrosi Investigative Site (300) | Auckland | |
| New Zealand | Arthrosi Investigative Site (302) | Auckland | |
| New Zealand | Arthrosi Investigative Site (304) | Hamilton | |
| New Zealand | Arthrosi Investigative Site (303) | Nelson | |
| New Zealand | Arthrosi Investigative Site (301) | Rotorua | |
| United States | Arthrosi Investigative Site (110) | Amarillo | Texas |
| United States | Arthrosi Investigative Site (139) | Anchorage | Alaska |
| United States | Arthrosi Investigative Site (121) | Ann Arbor | Michigan |
| United States | Arthrosi Investigative Site (101) | Aurora | Colorado |
| United States | Arthrosi Investigative Site (118) | Aventura | Florida |
| United States | Arthrosi Investigative Site (100) | Binghamton | New York |
| United States | Arthrosi Investigative Site (133) | Boise | Idaho |
| United States | Arthrosi Investigative Site (141) | Bothell | Washington |
| United States | Arthrosi Investigative Site (142) | Bountiful | Utah |
| United States | Arthrosi Investigative Site (113) | Brooklyn | New York |
| United States | Arthrosi Investigative Site (149) | Clearwater | Florida |
| United States | Arthrosi Investigative Site (148) | Cleveland | Ohio |
| United States | Arthrosi Investigative Site (109) | Colorado Springs | Colorado |
| United States | Arthrosi Investigative Site (115) | Coral Gables | Florida |
| United States | Arthrosi Investigative Site (104) | Dallas | Texas |
| United States | Arthrosi Investigative Site (146) | Dayton | Ohio |
| United States | Arthrosi Investigative Site (128) | DeLand | Florida |
| United States | Arthrosi Investigative Site (105) | Detroit | Michigan |
| United States | Arthrosi Investigative Site (143) | Edgewater | Florida |
| United States | Arthrosi Investigative Site (131) | El Cajon | California |
| United States | Arthrosi Investigative Site (117) | Encinitas | California |
| United States | Arthrosi Investigative Site (106) | Foley | Alabama |
| United States | Arthrosi Investigative Site (116) | Graham | Texas |
| United States | Arthrosi Investigative Site (137) | Greensboro | North Carolina |
| United States | Arthrosi Investigative Site (150) | Hagerstown | Maryland |
| United States | Arthrosi Investigative Site (111) | Hampton | Virginia |
| United States | Arthrosi Investigative Site (120) | Hatboro | Pennsylvania |
| United States | Arthrosi Investigative Site (102) | Hollywood | Florida |
| United States | Arthrosi Investigative Site (119) | Kansas City | Missouri |
| United States | Arthrosi Investigative Site (126) | Lake Jackson | Texas |
| United States | Arthrosi Investigative Site (103) | Miami | Florida |
| United States | Arthrosi Investigative Site (136) | Missouri City | Texas |
| United States | Arthrosi Investigative Site (147) | Myrtle Beach | South Carolina |
| United States | Arthrosi Investigative Site (108) | New Orleans | Louisiana |
| United States | Arthrosi Investigative Site (144) | New Orleans | Louisiana |
| United States | Arthrosi Investigative Site (145) | Ogden | Utah |
| United States | Arthrosi Investigative Site (135) | Ormond Beach | Florida |
| United States | Arthrosi Investigative Site (112) | Phoenix | Arizona |
| United States | Arthrosi Investigative Site (129) | Plano | Texas |
| United States | Arthrosi Investigative Site (138) | Rancho Cucamonga | California |
| United States | Arthrosi Investigative Site (132) | Rapid City | South Dakota |
| United States | Arthrosi Investigative Site (122) | River Forest | Illinois |
| United States | Arthrosi Investigative Site (127) | Round Rock | Texas |
| United States | Arthrosi Investigative Site (140) | Shelby | North Carolina |
| United States | Arthrosi Investigative Site (114) | Tempe | Arizona |
| United States | Arthrosi Investigative Site (107) | Tomball | Texas |
| United States | Arthrosi Investigative Site (124) | Tomball | Texas |
| United States | Arthrosi Investigative Site (130) | Wilmington | North Carolina |
| United States | Arthrosi Investigative Site (134) | Winchester | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Arthrosi Therapeutics |
United States, Australia, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 | 24 weeks | |
| Secondary | Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12 | 12 weeks | |
| Secondary | No gout flares from the end of month 9 to the end of month 12 | Comparison of the treatment groups for the proportion of patients with no gout flares for the 3-month period from the end of month 9 to the end of month 12 | 12 weeks | |
| Secondary | Monthly mean rate of gout flares by month 12 | Comparison of the treatment groups for monthly mean rate of gout flares for the 3-month period from the end of month 9 to the end of month 12 | 12 weeks | |
| Secondary | Change in tophus burden by month 12 | Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method | 48 weeks | |
| Secondary | Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence | 56 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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