drugset / Trial / NCT00655135

Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients

NCT00655135

Phase 2 Completed 185 enrolled Millennium Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The objectives of this study were to assess the safety and tolerability of LDP-02 in patients with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active Crohn's disease.

Timeline

Start
2000-02
Primary completion
2002-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 0.5 mg/kg Intravenous
Subject Vedolizumab Monoclonal antibody 2 mg/kg Intravenous

Indications