A Study to Compare the Efficacy of SEL-212 to Krystexxa in Gout Patients Refractory to Conventional Therapy

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    Recruiting
Updated on 23 November 2020

Summary

A Study to Compare the Efficacy of SEL-212 to Krystexxa in Gout Patients Refractory to Conventional Therapy

 

Description

Open Label

Details
Condition Arthritis and Arthritic Pain, Gout (Hyperuricemia)
Clinical Study IdentifierTX219143
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-80
Hx of ≥3 gout flares within 18 months of screening or presence of ≥1 tophus or current dx of gouty arthritis
Refractory gout, with a SUA ≥ 8 while on documented xanthine oxidase inhibitors, at a medically appropriate dose or who are deemed intolerant, per the investigator
Excl. prior exposure to SEL-03, Krystexxa or a PEG product
Excl. drugs known to interact with Rapamune
Excl. women of childbearing potential
Excl. gout flare during screening that was resolved for less than 1 week prior to first dose
Excl. uncontrolled diabetes at screening with HbA1c ≥ 8%
Excl. subjects taking Pradaxa, Xarelto, Savaysa, Coumadin or Eliquis
Excl. malignancy w/in 5 years
Excl. hx of severe alcohol or substance use within 12 months of randomization
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