Crohn's Disease
Conditions
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.
Interventions
DRUGLDP-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.
DRUGPlacebo
Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed