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

NCT ID: NCT00655135

Last Updated: 2008-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

2

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.

Group Type: EXPERIMENTAL

LDP-02

Intervention Type: DRUG

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.

3

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.

Group Type: EXPERIMENTAL

LDP-02

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

MLN0002, MLN02; MLN0002, MLN02

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Millennium Pharmaceuticals

References

Feagan BG, Greenberg GR, Wild G, Fedorak RN, Pare P, McDonald JW, Cohen A, Bitton A, Baker J, Dube R, Landau SB, Vandervoort MK, Parikh A. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1370-7. doi: 10.1016/j.cgh.2008.06.007. Epub 2008 Oct 1.

Reference Type: DERIVED

PMID: 18829392 (View on PubMed)

Other Identifiers

L299-016

Identifier Type: -

Identifier Source: org_study_id