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

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: LDP-02; Drug: Placebo

• Registration Number: NCT00655135
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2002-06
• Status Verified: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-08
• Last Update Submitted: 2008-04-08
• Study First Posted: 2008-04-09
• Last Update Posted: 2008-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	LDP-02	Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received 0.5 mg/kg of LDP-02 administered intravenously to patients on Day 1 and Day 29.
3	LDP-02	Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received 2 mg/kg of LDP-02 administered intravenously to patients on Day 1 and Day 29.
1	Placebo	Patients were assigned to arms in a 1:1:1 ratio. Patients in this arm received placebo administered intravenously to patients on Day 1 and Day 29.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was the proportion of patients with a clinical response, defined as a reduction from baseline in the CDAI score of at least 70 points at Day 57	Days 1-57