An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]
The present study (3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
- - Diagnosis of UC for at least 3 months.
- - Inadequate response or intolerance to conventional therapy for the treatment of
- Evidence of active UC based on the modified Mayo score
- No known history of active TB
- Agree to practicing abstinence or adhering to specific birth control requirements
Exclusion Criteria:- Participant has UC limited to the rectum - History of fulminant colitis, a diagnosis of Crohn's disease or indeterminate colitis specific complication of UC, including toxic megacolon - Previous intolerance or non-response to vedolizumab - Participants receiving exclusionary treatment within specified time periods - History of cancer, except for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Allergan|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Canada, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Colitis, Ulcerative, IBD|
|Study Website:||View Trial Website|
Contact a Trial Team
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