A Study To Evaluate The Effectiveness And Safety Of MEDI2070 In Subjects With Active Moderate To Severe Crohn's Disease
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004472
NCT ID: NCT02574637
Sponsor Protocol Number: D5170C00002
About this study
The purpose of this study is to evaluate the effectiveness 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening
- Men or women
- Age 18 - 80 years at the time of screening
- Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) AND endoscopic demonstration of inflammation
- Stable dose of medications for Crohn's disease therapy
- Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis-Factor-Alpha Therapy (anti-TNF α) agent
- Effective contraception from screening and for 36 weeks after the last dose of investigational product, including for female partners of male study subjects
- No known history of active tuberculosis (TB) & negative assessment for TB/latent TB
Exclusion Criteria
- Severe underlying immunosuppression
- Severe gastrointestinal complications e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
- Significant infections at screening
- Infected abscess, positive for Clostridium difficile, recent infectious hospitalization
- Recent treatment with approved or investigational biologic therapy for Crohn's disease
- Recent or planned live attenuated vaccine
- History of cancer, except for basal cell carcinoma or CIS of the cervix with apparent cure ≥ 12 months before screening
- Pregnancy/breast feeding
- Drug abuse
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Edward Loftus JR, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available