Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
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
3 other identifiers
interventional
121
9 countries
80
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2013
Typical duration for phase_2
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2012
CompletedFirst Posted
Study publicly available on registry
October 26, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2016
CompletedResults Posted
Study results publicly available
March 6, 2019
CompletedMay 26, 2021
May 1, 2021
1.3 years
October 24, 2012
September 21, 2018
May 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8
A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (\<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.
Week 8
Secondary Outcomes (17)
Percentage of Participants With CDAI-70 Point Improvement at Week 8
Week 8
Percentage of Participants With CDAI Response at Week 12
Week 12
Percentage of Participants With CDAI Remission at Week 8
Week 8
Percentage of Participants With CDAI-100 Point Improvement at Week 8
Week 8
Change From Baseline in CDAI Total Score at Week 8
Week 8
- +12 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALMEDI2070 iv infusion
2
PLACEBO COMPARATORplacebo iv infusion
open-label
EXPERIMENTALMEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or breastfeeding women.
- Presence of ileostomy and/or colostomy.
- Short bowel syndrome.
- Bowel perforation or obstruction.
- History of cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- MedImmune Ltdcollaborator
Study Sites (80)
Research Site
Encinitas, California, 92024, United States
Research Site
Los Angeles, California, 45242, United States
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San Diego, California, 92114, United States
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Torrance, California, 90505, United States
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Lakewood, Colorado, 80215, United States
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Jacksonville, Florida, 32256, United States
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Miami, Florida, 33136, United States
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Winter Park, Florida, 32789, United States
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Macon, Georgia, 31201, United States
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Chicago, Illinois, 60637, United States
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Baton Rouge, Louisiana, 70809, United States
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Hammond, Louisiana, 70403, United States
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Baltimore, Maryland, 21201, United States
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Chevy Chase, Maryland, 20815, United States
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Ann Arbor, Michigan, 48109, United States
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Troy, Michigan, 48098, United States
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Belton, Missouri, 64012, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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Asheville, North Carolina, 28801, United States
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Charlotte, North Carolina, 28207, United States
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Cincinnati, Ohio, 45219, United States
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Lima, Ohio, 45806, United States
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Germantown, Tennessee, 38138, United States
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San Antonio, Texas, 78229, United States
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Seattle, Washington, 98195, United States
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Edmonton, Alberta, T6G 2X8, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Guelph, Ontario, N1H 3R3, Canada
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Kingston, Ontario, K7L 5G2, Canada
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London, Ontario, N6A 5A5, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M6H 3M1, Canada
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Vaughan, Ontario, L4L 4Y7, Canada
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Montreal, Quebec, H3A 1A1, Canada
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České Budějovice, 370 01, Czechia
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Hradec Králové, 500 12, Czechia
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Litoměřice, 412 01, Czechia
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Ostrava-Poruba, 708 53, Czechia
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Prague, 100 34, Czechia
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Prague, 170 04, Czechia
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Amiens, 88054, France
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Clichy, 92210, France
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Pessac, 33604, France
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Rouen, F-76031 CE, France
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Toulouse, 31059, France
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Hamburg, 20246, Germany
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Hamburg, 20249, Germany
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München, 80331, Germany
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Potsdam, 14482, Germany
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Budapest, 1062, Hungary
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Budapest, 1081, Hungary
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Budapest, 1125, Hungary
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Kaposvár, 7400, Hungary
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Szombathely, 9700, Hungary
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Bologna, 40138, Italy
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Florence, 50141, Italy
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Milan, 20100, Italy
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Napoli, 80131, Italy
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Roma, 133, Italy
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Roma, 196, Italy
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Rozzano, 20089, Italy
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Bydgoszcz, 85-168, Poland
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Bydgoszcz, 85-681, Poland
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Opole, 45-061, Poland
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Rzeszów, 35-301, Poland
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Sopot, 81-756, Poland
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Sosnowiec, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 53-333, Poland
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Barcelona, 8025, Spain
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Barcelona, 8035, Spain
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Barcelona, 8916, Spain
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L'Hospitalet de Llobregat, 8907, Spain
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Sabadell(Barcelona), 8208, Spain
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Seville, 41014, Spain
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Seville, 41071, Spain
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Valencia, 46026, Spain
Related Publications (2)
Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.
PMID: 28390867BACKGROUNDDanese S, Beaton A, Duncan EA, Mercier AK, Neisen J, Seth H, Zetterstrand S, Sands BE. Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn's disease. BMC Gastroenterol. 2023 Dec 20;23(1):451. doi: 10.1186/s12876-023-03078-7.
PMID: 38124112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A formal statistical analysis was not performed.
Results Point of Contact
- Title
- Clinical Study Information Center
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2012
First Posted
October 26, 2012
Study Start
February 1, 2013
Primary Completion
May 20, 2014
Study Completion
December 14, 2016
Last Updated
May 26, 2021
Results First Posted
March 6, 2019
Record last verified: 2021-05