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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Placebo; Drug: LDP-02

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Placebo; Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.; Other Names: MLN0002, MLN02
Experimental: 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.	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.; Other Names: MLN0002, MLN02
Experimental: 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.	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.; Other Names: MLN0002, MLN02

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Primary Completion (Actual): June 1, 2002

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): April 9, 2008
• Last Update Submitted That Met QC Criteria: April 8, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: L299-016