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

A

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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