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Trial record 1 of 1 for:    AR882-202
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05119686
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : December 13, 2021
Sponsor:
Information provided by (Responsible Party):
Arthrosi Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

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




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 ]
    Adverse event 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.



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Director Clinical Operations +1 949-393-2676 info@arthrosi.com

Locations
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United States, Ohio
Arthrosi Investigative Site Not yet recruiting
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Arthrosi Investigative Site Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Arthrosi I Site         
United States, Texas
Arthrosi Investigative Site Recruiting
Dallas, Texas, United States, 75231
Contact: Arthrosi I Site         
Arthrosi Investigative Site Recruiting
Houston, Texas, United States, 77074
Contact: Arthrosi I Site         
United States, Utah
Arthrosi Investigative Site Not yet recruiting
Salt Lake City, Utah, United States, 84088
Contact: Arthrosi I Site         
Australia, Camberwell
Arthrosi Investigative Site Recruiting
Melbourne, Camberwell, Australia, 3124
Contact: Arthrosi I Site         
Australia, New South Wales
Arthrosi Investigative Site Recruiting
Sydney, New South Wales, Australia
Sponsors and Collaborators
Arthrosi Therapeutics
Investigators
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Study Chair: R Keenan, MD Arthrosi Therapeutics
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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: December 13, 2021
Last Verified: December 2021

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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