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Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

Primary Purpose

Gout, Arthritis, Gouty, Hyperuricemia

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AR882 Dose 1
AR882 Dose 2
Allopurinol Tablet
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
  • at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
  • Patients who are NOT on approved ULT must have sUA > 7 mg/dL
  • Patients who are on medically appropriate ULT must have sUA > 6 mg/dL
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2

Exclusion Criteria:

  • Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
  • Pregnant or breastfeeding
  • History of kidney stones

Sites / Locations

  • Arthrosi Investigative Site (410)
  • Arthrosi Investigative Site (403)
  • Arthrosi Investigative Site (416)
  • Arthrosi Investigative Site (417)
  • Arthrosi Investigative Site (402)
  • Arthrosi Investigative Site (404)
  • Arthrosi Investigative Site (409)
  • Arthrosi Investigative Site (406)
  • Arthrosi Investigative Site (408)
  • Arthrosi Investigative Site (401)
  • Arthrosi Investigative Site (201)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Allopurinol once daily for 24 weeks

AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks

AR882 Dose 1 + Allopurinol for 24 weeks

Outcomes

Primary Outcome Measures

Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3

Secondary Outcome Measures

Change from baseline in tophus area at Months 3 and 6
Comparison of the treatment groups for tophus area as measured by digital calipers
Change from baseline in tophus crystal volume at Months 6
Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Incidence of Adverse Events
Treatment Emergent Adverse Events and Serious Adverse Event incidence.

Full Information

First Posted
February 15, 2022
Last Updated
July 18, 2023
Sponsor
Arthrosi Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05253833
Brief Title
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
Official Title
A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Optional Extension to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
February 14, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

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 urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 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
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Allopurinol once daily for 24 weeks
Arm Title
Group 2
Arm Type
Experimental
Arm Description
AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks
Arm Title
Group 3
Arm Type
Experimental
Arm Description
AR882 Dose 1 + Allopurinol for 24 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)
Allopurinol Tablet
Intervention Description
Solid tablet
Primary Outcome Measure Information:
Title
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Description
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in tophus area at Months 3 and 6
Description
Comparison of the treatment groups for tophus area as measured by digital calipers
Time Frame
12 weeks and 24 weeks
Title
Change from baseline in tophus crystal volume at Months 6
Description
Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.
Time Frame
24 weeks
Title
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Description
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Time Frame
12 weeks
Title
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Description
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Time Frame
24 weeks
Title
Incidence of Adverse Events
Description
Treatment Emergent Adverse Events and Serious Adverse Event incidence.
Time Frame
24 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 at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter. Patients who are NOT on approved ULT must have sUA > 7 mg/dL Patients who are on medically appropriate ULT must have sUA > 6 mg/dL Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2 Exclusion Criteria: Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin Pregnant or breastfeeding 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 (410)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arthrosi Investigative Site (403)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arthrosi Investigative Site (416)
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Arthrosi Investigative Site (417)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arthrosi Investigative Site (402)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Arthrosi Investigative Site (404)
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Arthrosi Investigative Site (409)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Arthrosi Investigative Site (406)
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Arthrosi Investigative Site (408)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29577
Country
United States
Facility Name
Arthrosi Investigative Site (401)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Arthrosi Investigative Site (201)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

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