A Phase 2, Open Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Crohn's Disease.
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.
- 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 250mg IV Q4W or 100mg IV Q4W until week
- Subjects who do not respond by 12 weeks will be discontinued
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