Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/8/2019 |
Start Date: | February 1, 2013 |
End Date: | December 14, 2016 |
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
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
placebo. Investigational product will be administered as intravenous infusion in double-blind
period, and as a subcutaneous injection in open-label period
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.
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.
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.
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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