Status:
COMPLETED
Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ab...
Eligibility Criteria
Inclusion
- Age 18 to 80, nonhospitalized, male or nonpregnant, nonlactating females voluntarily able to give informed consent.
- Crohn's disease of at least 6 months' duration.
- Endoscopic and/or histopathological and/or radiological documentation consistent with Crohn's disease obtained preferably within 24 months of screening.
- Crohn's disease involving the colon and/or the ileum.
- CDAI score from 220 to 400 (inclusive) at the time of the Screening visit. The CDAI must have remained between 220 and 400 after the 1-week Screening period for the patient to be eligible.
- Patients may have been receiving oral or topical 5-ASA compounds provided the dosage had been stable for at least the 14-day period before the Screening visit. Patients were to be maintained on the 5-ASA compound at a constant dose at least through Day 57.
Exclusion
- Patients with evidence of current GI infection (bacterial or parasitic) or significant infection within 45 days of the screening visit.
- Patients with a serious underlying disease other than Crohn's disease including presence or history of malignancy (except basal cell carcinoma) and histological evidence of dysplasia.
- Patients with significantly impaired liver or renal function. This includes those with established chronic liver disease including hepatitis B or C.
- Patients with the laboratory abnormalities
- Patients using ethanol or consuming illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures.
- Patients with active psychiatric problems which, in the investigator's opinion, may interfere with compliance with the study procedures.
- Patients who have previously received or who are currently receiving treatment with a monoclonal antibody.
- Patients receiving any investigational therapy, excluded medications as defined in protocol, or any approved therapy in an investigational protocol within 30 days prior to screening.
- Patients unable to attend all the study visits or comply with study procedures.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00655135
Start Date
February 1 2000
Last Update
April 9 2008
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