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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LDP-02
Placebo
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2008
    Last Updated
    April 8, 2008
    Sponsor
    Millennium Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00655135
    Brief Title
    Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients
    Official Title
    Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2000 (undefined)
    Primary Completion Date
    June 2002 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Millennium Pharmaceuticals, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    185 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm 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.
    Arm Title
    2
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    3
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    LDP-02
    Other Intervention Name(s)
    MLN0002, MLN02
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    MLN0002, MLN02
    Intervention Description
    Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.
    Primary Outcome Measure Information:
    Title
    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
    Time Frame
    Days 1-57

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18829392
    Citation
    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. Erratum In: Clin Gastroenterol Hepatol. 2009 Apr;7(4):494.
    Results Reference
    derived

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

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