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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05119686
Recruitment Status : Completed
First Posted : November 15, 2021
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
Arthrosi Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gout Arthritis, Gouty Hyperuricemia Gout Chronic Drug: AR882 Dose 1 Drug: AR882 Dose 2 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
Actual Study Start Date : November 16, 2021
Actual Primary Completion Date : November 17, 2022
Actual Study Completion Date : November 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
AR882 Dose 1 x 12 weeks
 Drug: AR882 Dose 1
Solid Oral Capsule
Experimental: Group 2
AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
 Drug: AR882 Dose 1
Solid Oral Capsule

Drug: AR882 Dose 2
Solid Oral Capsule
Placebo Comparator: Group 3
AR882 matching placebo x 12 weeks
 Drug: Placebo
Matching Solid Oral Capsule Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing [ Time Frame: 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 Outcome Measures :
  1. sUA levels < 5, < 4, and < 3 mg/dL [ Time Frame: 6 weeks ]
    Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL

  2. Incidence of Adverse Events [ Time Frame: 14 weeks ]
    Treatment Emergent Adverse Events and Serious Adverse Event incidence.

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 12 weeks ]
    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.

  4. Time to observed Cmax (Tmax) [ Time Frame: 12 weeks ]
    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.

  5. Area under the plasma concentration-time curve (AUC) [ Time Frame: 12 weeks ]
    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05119686


Locations
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United States, Arizona
Arthrosi Investigative Site
Gilbert, Arizona, United States, 85297
Arthrosi Investigative Site
Sun City, Arizona, United States, 85351
Arthrosi Investigative Site
Tucson, Arizona, United States, 85704
United States, Florida
Arthrosi Investigative Site
Miami Lakes, Florida, United States, 33014
Arthrosi Investigative Site
Miami, Florida, United States, 33143
Arthrosi Investigative Site
Tampa, Florida, United States, 33613
United States, Hawaii
Arthrosi Investigative Site
Honolulu, Hawaii, United States, 96814
United States, Kansas
Arthrosi Investigative Site
Overland Park, Kansas, United States, 66212
United States, Ohio
Arthrosi Investigative Site
Cleveland, Ohio, United States, 44122
Arthrosi Investigative Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Arthrosi Investigative Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Arthrosi Investigative Site
Dallas, Texas, United States, 75231
Arthrosi Investigative Site
Houston, Texas, United States, 77074
Arthrosi Investigative Site
Tomball, Texas, United States, 77375
United States, Utah
Arthrosi Investigative Site
West Jordan, Utah, United States, 84088
United States, Wisconsin
Arthrosi Investigative Site
Glendale, Wisconsin, United States, 53217
Australia, Camberwell
Arthrosi Investigative Site
Melbourne, Camberwell, Australia, 3124
Australia, New South Wales
Arthrosi investigative Site
Botany, New South Wales, Australia, 2019
Taiwan
Arthrosi Investigative Site
Taichung City, Taiwan, 402
Arthrosi Investigative Site - 301
Taipei City, Taiwan, 112
Arthrosi Investigative Site - 304
Taipei City, Taiwan, 112
Arthrosi Investigative Site
Taipei City, Taiwan, 114
Arthrosi Investigative Site
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Arthrosi Therapeutics
Investigators
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Study Chair: R Keenan, MD Arthrosi Therapeutics
More Information
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Responsible Party: Arthrosi Therapeutics
ClinicalTrials.gov Identifier: NCT05119686    
Other Study ID Numbers: AR882-202
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gout
Arthritis, Gouty
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
 Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes