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

Millennium Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: LDP-02; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655135

L299-016

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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185 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

2

Experimental group

Description:

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.

Treatment:

Drug: LDP-02

3

Experimental group

Description:

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.

Treatment:

Drug: LDP-02