Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients

Arthrosi Therapeutics

Status and phase: Completed; Phase 2

Conditions: Gout Patients

Treatments: Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX); Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04155918

AR882-201

Details and patient eligibility

About

The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• History of gout
• sUA > 7 mg/dL
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2

Key Exclusion Criteria:

• Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
• History of cardiac abnormalities
• Active peptic ulcer disease or active liver disease
• History of kidney stones
• Allergy or intolerance to colchicine, febuxostat, and allopurinol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

AR882/FBX

Experimental group

Treatment:

Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)

AR882/ALLO

Experimental group

Treatment:

Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)