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Prometheus Biosciences - Ulcerative Colitis

A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis

  • PRA023 is a humanized IgG1k monoclonal antibody that binds human TL1A with high affinity and specificity. PRA023 is derived from the murine monoclonal antibody 5C3D11, which was discovered using conventional hybridoma technology. PRA023 consists of the 5C3D11 complementarity-determining regions (CDRs) grafted to human sequences from the IGHV1 and IGKV3 families. PRA023 incorporates Fc mutations to avoid ADCC and CDC.
  • Moderate to Severe UC, 70% max prior biologic exposure
  • Cannot have failed 3 or more classes or 4 or more individual biologic therapies
  • Must be on stable doses of Oral aminosalicylates and oral corticosteroids for 2 weeks (< 20mg prednisone or </= 9mg budesonide or Beclamethasone </= 5mg)
  • Randomized 1:1 to receive PRA023 Vs. Placebo Week 0-12
  • PRA023 1000 mg IV on Week 0/Day 1, followed by 500 mg IV on Weeks 2, 6, and 10
    • PRA023 1000 mg IV on Week 0/Day 1, followed by 500 mg IV on Weeks 2, 6, and 10
    • Placebo IV on Week 0/Day 1, followed by placebo IV on Weeks 2, 6, and 10
  • Up to 50 week trial duration including the Open Label Extension portion of this trial starting at week 12:
    • PRA023 250 mg IV on Week 28 then Q4W for a total of 50 weeks or PRA023 100 mg IV on Week 28 then Q4W for a total of 50 weeks

    If you are interested in participating in clinical studies, please send an email to wagiresearch@washgi.com.


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