An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of UC for at least 3 months.
  • - Inadequate response or intolerance to conventional therapy for the treatment of ulcerative colitis - 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.
- Clinically significant infections - Clinically significant cardiovascular conditions

Trial Details

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.

Trial ID:
NCT03616821

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.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Allergan

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Aparna Sahoo
Principal Investigator Affiliation Allergan

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Colitis, Ulcerative, IBD
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Applied Research Center of Arkansas, Little Rock, Arkansas

Status

Recruiting

Address

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212

Site Contact

877‐277‐8566

Clincal Applications Laboratories, Inc., San Diego, California

Status

Not yet recruiting

Address

Clincal Applications Laboratories, Inc.

San Diego, California, 92103

Site Contact

877‐277‐8566

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Site Contact

877‐277‐8566

Clearwater, Florida

Status

Recruiting

Address

Gastroenterology Consultants of Clearwater

Clearwater, Florida, 33756

Site Contact

877‐277‐8566

American Research Institute, Cutler Bay, Florida

Status

Not yet recruiting

Address

American Research Institute

Cutler Bay, Florida, 33157

Site Contact

877‐277‐8566

Wellness Clinical Research, Hialeah, Florida

Status

Not yet recruiting

Address

Wellness Clinical Research

Hialeah, Florida, 33012

Site Contact

877‐277‐8566

C&R Research Services, Lake Worth, Florida

Status

Recruiting

Address

C&R Research Services

Lake Worth, Florida, 33461

Site Contact

877‐277‐8566

Medical Professional Clinical Research, Miami, Florida

Status

Not yet recruiting

Address

Medical Professional Clinical Research

Miami, Florida, 33165

Site Contact

877‐277‐8566

Advanced Research, Inc, New Port Richey, Florida

Status

Not yet recruiting

Address

Advanced Research, Inc

New Port Richey, Florida, 34653

Site Contact

877‐277‐8566

Gastro Florida, Tampa, Florida

Status

Recruiting

Address

Gastro Florida

Tampa, Florida, 33626

Site Contact

877‐277‐8566

Illinois Gastroenterology Group, Gurnee, Illinois

Status

Recruiting

Address

Illinois Gastroenterology Group

Gurnee, Illinois, 60031

Site Contact

877‐277‐8566

Investigator Research Group, LLC, Brownsburg, Indiana

Status

Recruiting

Address

Investigator Research Group, LLC

Brownsburg, Indiana, 46112

Site Contact

877‐277‐8566

Lucas Research, Morehead City, North Carolina

Status

Not yet recruiting

Address

Lucas Research

Morehead City, North Carolina, 28571

Site Contact

877‐277‐8566

Consultants for Clinical Research, Inc., Cincinnati, Ohio

Status

Not yet recruiting

Address

Consultants for Clinical Research, Inc.

Cincinnati, Ohio, 45219

Site Contact

877‐277‐8566

Central Sooner Research, Norman, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

Site Contact

877‐277‐8566

Digestive Disease Specialists (DDSI), Oklahoma City, Oklahoma

Status

Not yet recruiting

Address

Digestive Disease Specialists (DDSI)

Oklahoma City, Oklahoma, 73112

Site Contact

877‐277‐8566

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