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

NCT00655135 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2008-04-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LDP-02

Each patient in arms 2 \& 3 received a single IV dose of study drug at 0.5 or 2.0 mg/kg LDP-02 on Days 1 and 29.

DRUG

Placebo

Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2002-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655135 on ClinicalTrials.gov