Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: MEDI2070; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01714726

EudraCT number: 2012-004098-26

D5170C00001

2012-004098-26 (EudraCT Number)

Details and patient eligibility

About

The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period

Full description

This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled, treatment period followed by a 100-week, open label, treatment period to evaluate short-term efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the 12-week, double-blind, placebo-controlled, treatment period. At the completion of the double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070 (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28 weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after their last dose of IP for safety.

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
• Men or women age 18 - 65 years at the time of screening.
• Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.
• No known history of active tuberculosis (TB).
• Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.

Exclusion criteria

• Pregnant or breastfeeding women.
• Presence of ileostomy and/or colostomy.
• Short bowel syndrome.
• Bowel perforation or obstruction.
• History of cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

MEDI2070 iv infusion

Treatment:

Drug: MEDI2070

2

Placebo Comparator group

Description:

placebo iv infusion

Treatment:

Drug: placebo

open-label

Experimental group

Description:

MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period

Treatment:

Drug: MEDI2070