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

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Gout (Hyperuricemia)

Treatment

N/A

Clinical Study ID

TX219143
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

  • 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

Study Design

Study Start date:
Estimated Completion Date:

Study Description

Open Label

Connect with a study center

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland 20902
    United States

    Active - Recruiting

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