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

• Sponsor: Arthrosi Therapeutics (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05253833
• Collaborator: (none)
• Enrollment: 36
• Locations: 3
• Arms: 3
• Anticipated Duration (Months): 11
• Patients Per Site: 12
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gout; Arthritis, Gouty; Hyperuricemia; Gout Chronic	Drug: AR882 Dose 1; Drug: AR882 Dose 2; Drug: Allopurinol Tablet	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients
• Anticipated Study Start Date: Jul 30, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Allopurinol once daily for 24 weeks	Drug: Allopurinol Tablet; Solid tablet
Experimental: Group 2 AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks	Drug: AR882 Dose 1; Solid Oral Capsule; Drug: AR882 Dose 2; Solid Oral Capsule
Experimental: Group 3 AR882 Dose 1 + Allopurinol for 24 weeks	Drug: AR882 Dose 1; Solid Oral Capsule; Drug: Allopurinol Tablet; Solid tablet

Outcome Measures

Primary Outcome Measures

1. Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 [12 weeks]

   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

1. Change from baseline in tophus area at Months 3 and 6 [12 weeks and 24 weeks]

   Comparison of the treatment groups for tophus area as measured by digital calipers

2. Change from baseline in tophus crystal volume at Months 6 [24 weeks]

   Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.

3. Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3 [12 weeks]

   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

4. Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6 [24 weeks]

   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

5. Incidence of Adverse Events [24 weeks]

   Treatment Emergent Adverse Events and Serious Adverse Event incidence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arthrosi Investigative Site (403)	Phoenix	Arizona	United States	85032
2	Arthrosi Investigative Site (417)	Tucson	Arizona	United States	85704
3	Arthrosi Investigative Site (408)	Myrtle Beach	South Carolina	United States	29577

Sponsors and Collaborators

• Arthrosi Therapeutics

Investigators

• Study Chair: R Keenan, MD, Arthrosi Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arthrosi Therapeutics
• ClinicalTrials.gov Identifier: NCT05253833
• Other Study ID Numbers: AR882-203
• First Posted: Feb 24, 2022
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gout; Arthritis, Gouty; Hyperuricemia; Allopurinol

Study Results

No Results Posted as of Jul 15, 2022