Phase 3 N=324 Randomized Triple-blind Treatment

Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat

Tophaceous Gout

Bottom Line

View on ClinicalTrials.gov: NCT01510769 ↗

Enrolled (actual)

324

Serious AEs

7.7%

Results posted

May 2016

Primary outcome: Primary: Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6 — 0.566; 0.761; 0.468 Proportion of Subjects — p=0.1298

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lesinurad (Drug); Placebo (Drug); Febuxostat (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ardea Biosciences, Inc.
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6	0.566; 0.761; 0.468	0.1298
SECONDARY Complete Resolution of at Least One Target Tophus	0.255; 0.303; 0.211	0.4453
SECONDARY Complete or Partial Response of at Least One Tophus	0.566; 0.587; 0.505	0.6450
SECONDARY Quality of Life	0.442; 0.333; 0.525	0.3034

Summary

This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.

Eligibility Criteria

Inclusion Criteria

Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
Subject is willing to adhere to the visit/protocol schedules.
Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of Acute Arthritis of Primary Gout.
Subject meets one of the following criteria:
Subjects who are not currently taking an approved ULT must have an sUA value of ≥ 8 mg/dL (476 µmol/L).
Subjects entering the study on a medically appropriate dose of febuxostat or allopurinol must have an sUA value of ≥ 6.0 mg/dL (357 µmol/L).
Subject must be able to take gout flare prophylaxis with colchicine or non-steroidal anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.
Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 20 mm in the longest diameter.
Body mass index (BMI) 2.5 x ULN at any time during the Screening Period.
Subject with active peptic ulcer disease requiring treatment.
Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
Subject receiving chronic treatment with more than 325 mg of salicylates per day.
Subject taking valpromide, progabide, or valproic acid.
Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.
Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01510769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.