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

Primary Purpose

Gout, Arthritis, Gouty, Hyperuricemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AR882 Dose 1
AR882 Dose 2
Placebo
Sponsored by
Arthrosi Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site
  • Arthrosi investigative Site
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site - 301
  • Arthrosi Investigative Site - 304
  • Arthrosi Investigative Site
  • Arthrosi Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

AR882 Dose 1 x 12 weeks

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

AR882 matching placebo x 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

sUA levels < 5, < 4, and < 3 mg/dL
Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL
Incidence of Adverse Events
Treatment Emergent Adverse Events and Serious Adverse Event incidence.
Maximum Observed Plasma Concentration (Cmax)
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.
Time to observed Cmax (Tmax)
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.
Area under the plasma concentration-time curve (AUC)
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.

Full Information

First Posted
October 20, 2021
Last Updated
May 6, 2023
Sponsor
Arthrosi Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05119686
Brief Title
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
Official Title
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arthrosi Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
AR882 Dose 1 x 12 weeks
Arm Title
Group 2
Arm Type
Experimental
Arm Description
AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Description
AR882 matching placebo x 12 weeks
Intervention Type
Drug
Intervention Name(s)
AR882 Dose 1
Intervention Description
Solid Oral Capsule
Intervention Type
Drug
Intervention Name(s)
AR882 Dose 2
Intervention Description
Solid Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Solid Oral Capsule Placebo
Primary Outcome Measure Information:
Title
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
sUA levels < 5, < 4, and < 3 mg/dL
Description
Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL
Time Frame
6 weeks
Title
Incidence of Adverse Events
Description
Treatment Emergent Adverse Events and Serious Adverse Event incidence.
Time Frame
14 weeks
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.
Time Frame
12 weeks
Title
Time to observed Cmax (Tmax)
Description
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.
Time Frame
12 weeks
Title
Area under the plasma concentration-time curve (AUC)
Description
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Keenan, MD
Organizational Affiliation
Arthrosi Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Arthrosi Investigative Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Arthrosi Investigative Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Arthrosi Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arthrosi Investigative Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Arthrosi Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Arthrosi Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Arthrosi Investigative Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Arthrosi Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Arthrosi Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Arthrosi Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthrosi Investigative Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthrosi Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Arthrosi Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Arthrosi Investigative Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Arthrosi Investigative Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Arthrosi Investigative Site
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Arthrosi Investigative Site
City
Melbourne
State/Province
Camberwell
ZIP/Postal Code
3124
Country
Australia
Facility Name
Arthrosi investigative Site
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
Arthrosi Investigative Site
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Arthrosi Investigative Site - 301
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Arthrosi Investigative Site - 304
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Arthrosi Investigative Site
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Arthrosi Investigative Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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