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

Accepts Healthy Volunteers

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

No
Study Type

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.

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

Trial ID:

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.

NCT03616821
Phase

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 2
Lead Sponsor

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

Allergan
Principal Investigator

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

Aparna Sahoo
Principal Investigator Affiliation Allergan
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, Puerto Rico, United States
Conditions

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

Colitis, Ulcerative, IBD
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Brazikumab Dose 1

Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71

Experimental: Brazikumab Dose 2

Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.

Experimental: Brazikumab Dose 3

Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.

Active Comparator: Vedolizumab

Intravenous vedolizumab on day 1, day 15, and day 43 followed by IV vedolizumab every 8 weeks beginning at day 99.

Placebo Comparator: Placebo

Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning at day 71.

Interventions

Drug: - Brazikumab

Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.

Drug: - Vedolizumab

Intravenous vedolizumab on day 1, day 15, and day 43 followed by Intravenous vedolizumab every 8 weeks beginning at day 99.

Drug: - Placebo

Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning at day 71.

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.

Scottsdale, Arizona

Status

Active, not recruiting

Address

Arizona Arthritis & Rheumatology Research

Scottsdale, Arizona, 85032

Del Sol Research Management, LLC, Tucson, Arizona

Status

Recruiting

Address

Del Sol Research Management, LLC

Tucson, Arizona, 85745

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

520-468-6113

Applied Research Center of Arkansas, Little Rock, Arkansas

Status

Active, not recruiting

Address

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212

Clinical Trials Specialist, Inc., Beverly Hills, California

Status

Active, not recruiting

Address

Clinical Trials Specialist, Inc.

Beverly Hills, California, 90211

Ventura Gastroenterolgy Medical Group, Camarillo, California

Status

Active, not recruiting

Address

Ventura Gastroenterolgy Medical Group

Camarillo, California, 93012

eStudySite, Chula Vista, California

Status

Recruiting

Address

eStudySite

Chula Vista, California, 91911

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

619-955-5246

VVCRD Clinical Research, Garden Grove, California

Status

Active, not recruiting

Address

VVCRD Clinical Research

Garden Grove, California, 92845

Om Research LLC, Lancaster, California

Status

Recruiting

Address

Om Research LLC

Lancaster, California, 93534

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

661-388-2239

Clinical Trials Research, Lincoln, California

Status

Recruiting

Address

Clinical Trials Research

Lincoln, California, 95648

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

916-434-8230

United Medical Doctors, Los Alamitos, California

Status

Active, not recruiting

Address

United Medical Doctors

Los Alamitos, California, 90720

Gastroinestinal Biosciences, Los Angeles, California

Status

Active, not recruiting

Address

Gastroinestinal Biosciences

Los Angeles, California, 90036

ACRC Studies, Poway, California

Status

Active, not recruiting

Address

ACRC Studies

Poway, California, 92064

Breakthrough Clinical Trials, LLC, San Bernardino, California

Status

Withdrawn

Address

Breakthrough Clinical Trials, LLC

San Bernardino, California, 92408

Clincal Applications Laboratories, Inc., San Diego, California

Status

Active, not recruiting

Address

Clincal Applications Laboratories, Inc.

San Diego, California, 92103

Lomita Family Medical Group, Inc, San Diego, California

Status

Withdrawn

Address

Lomita Family Medical Group, Inc

San Diego, California, 92114

Ritchken & First MD's, San Diego, California

Status

Withdrawn

Address

Ritchken & First MD's

San Diego, California, 92117

Care Access Research, San Pablo, California

Status

Active, not recruiting

Address

Care Access Research

San Pablo, California, 94806

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

719-636-1201

Plasma Med Research, Boca Raton, Florida

Status

Withdrawn

Address

Plasma Med Research

Boca Raton, Florida, 33487

Clearwater, Florida

Status

Recruiting

Address

Gastroenterology Consultants of Clearwater

Clearwater, Florida, 33756

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

727-827-7685

American Research Institute, Cutler Bay, Florida

Status

Withdrawn

Address

American Research Institute

Cutler Bay, Florida, 33157

Top Medical Research, Inc, Cutler Bay, Florida

Status

Recruiting

Address

Top Medical Research, Inc

Cutler Bay, Florida, 33189

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

305-971-6883

Wellness Clinical Research, Hialeah, Florida

Status

Recruiting

Address

Wellness Clinical Research

Hialeah, Florida, 33012

Site Contact

Study Contact

IR‐CTRegistration@Allergan.com

786-483-7856

SIH Research, Kissimmee, Florida

Status

Active, not recruiting

Address

SIH Research

Kissimmee, Florida, 34741

C&R Research Services, Lake Worth, Florida

Status

Active, not recruiting

Address

C&R Research Services

Lake Worth, Florida, 33461

Auzmer Research, Lakeland, Florida

Status

Recruiting

Address

Auzmer Research

Lakeland, Florida, 33813

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

863-450-2580

Sanchez Clinical Research, Inc, Miami, Florida

Status

Recruiting

Address

Sanchez Clinical Research, Inc

Miami, Florida, 33157

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

305-234-9484

Medical Professional Clinical Research, Miami, Florida

Status

Recruiting

Address

Medical Professional Clinical Research

Miami, Florida, 33165

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

786-801-1360

Valencia Medial & Research Center, Miami, Florida

Status

Active, not recruiting

Address

Valencia Medial & Research Center

Miami, Florida, 33165

Advanced Research, Inc, New Port Richey, Florida

Status

Active, not recruiting

Address

Advanced Research, Inc

New Port Richey, Florida, 34653

Sensible Healthcare, Ocoee, Florida

Status

Withdrawn

Address

Sensible Healthcare

Ocoee, Florida, 34761

Innovative Health, Pembroke Pines, Florida

Status

Withdrawn

Address

Innovative Health

Pembroke Pines, Florida, 33026

Advanced Research Institute Inc, Saint Petersburg, Florida

Status

Recruiting

Address

Advanced Research Institute Inc

Saint Petersburg, Florida, 33710

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

727-835-3261

Guardian Angel Research Center, Tampa, Florida

Status

Active, not recruiting

Address

Guardian Angel Research Center

Tampa, Florida, 33614

Gastro Florida, Tampa, Florida

Status

Active, not recruiting

Address

Gastro Florida

Tampa, Florida, 33626

Agile Clinical Research Trials, Atlanta, Georgia

Status

Withdrawn

Address

Agile Clinical Research Trials

Atlanta, Georgia, 30328

Decatur, Georgia

Status

Active, not recruiting

Address

Atlanta Center for Gastroenterology and Atlanta Endoscopy Center

Decatur, Georgia, 30030

Atlanta Gastroenterology Specialists, Suwanee, Georgia

Status

Active, not recruiting

Address

Atlanta Gastroenterology Specialists

Suwanee, Georgia, 30024

Northwest Gastroenterology Group, Arlington, Illinois

Status

Active, not recruiting

Address

Northwest Gastroenterology Group

Arlington, Illinois, 60005

Illinois Gastroenterology Group, Gurnee, Illinois

Status

Active, not recruiting

Address

Illinois Gastroenterology Group

Gurnee, Illinois, 60031

Investigators Research Group, LLC, Brownsburg, Indiana

Status

Active, not recruiting

Address

Investigators Research Group, LLC

Brownsburg, Indiana, 46112

Qualmedica Research, LLC, Evansville, Indiana

Status

Recruiting

Address

Qualmedica Research, LLC

Evansville, Indiana, 47715

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

812-454-9625

Ideal Health, Shawnee Mission, Kansas

Status

Withdrawn

Address

Ideal Health

Shawnee Mission, Kansas, 66226

Kansas Medical Clinic, Topeka, Kansas

Status

Recruiting

Address

Kansas Medical Clinic

Topeka, Kansas, 66606

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

785-354-0735

Gastroenterology Associates, LLC, Baton Rouge, Louisiana

Status

Active, not recruiting

Address

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, 70809

Tandem Clinical Research, Marrero, Louisiana

Status

Active, not recruiting

Address

Tandem Clinical Research

Marrero, Louisiana, 70072

Capital Research, Rockville, Maryland

Status

Withdrawn

Address

Capital Research

Rockville, Maryland, 20850

Detroit Clinical Research Center PC, Farmington Hills, Michigan

Status

Active, not recruiting

Address

Detroit Clinical Research Center PC

Farmington Hills, Michigan, 48336

The Center for Clinical Trials, Biloxi, Mississippi

Status

Withdrawn

Address

The Center for Clinical Trials

Biloxi, Mississippi, 39531

Biloxi, Mississippi

Status

Withdrawn

Address

Gen 1 Research - National Diabetes and Obesity Research Institute

Biloxi, Mississippi, 39532

Papillion, Nebraska

Status

Recruiting

Address

Synexus Clinical Research US / McGill Family Practice

Papillion, Nebraska, 68048

Jubilee Clinical Research, Las Vegas, Nevada

Status

Withdrawn

Address

Jubilee Clinical Research

Las Vegas, Nevada, 89106

Advanced Biomedical Research of America, Las Vegas, Nevada

Status

Active, not recruiting

Address

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123

Lovelace Scientific Resources, Inc., Albuquerque, New Mexico

Status

Recruiting

Address

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

505-348-9500

Trialspark, Inc., Astoria, New York

Status

Withdrawn

Address

Trialspark, Inc.

Astoria, New York, 11104

Trialspark, Inc., Brooklyn, New York

Status

Withdrawn

Address

Trialspark, Inc.

Brooklyn, New York, 11218

Trialspark, Inc., Brooklyn, New York

Status

Withdrawn

Address

Trialspark, Inc.

Brooklyn, New York, 11235

Trialspark, Inc., New York, New York

Status

Withdrawn

Address

Trialspark, Inc.

New York, New York, 10012

Manhattan Medical Research Practice PLLC, New York, New York

Status

Active, not recruiting

Address

Manhattan Medical Research Practice PLLC

New York, New York, 10016

Trialspark, Inc., New York, New York

Status

Withdrawn

Address

Trialspark, Inc.

New York, New York, 10016

Lucas Research, Morehead City, North Carolina

Status

Withdrawn

Address

Lucas Research

Morehead City, North Carolina, 28571

Great Lakes Medical Research, Beachwood, Ohio

Status

Active, not recruiting

Address

Great Lakes Medical Research

Beachwood, Ohio, 44122

Consultants for Clinical Research, Inc., Cincinnati, Ohio

Status

Withdrawn

Address

Consultants for Clinical Research, Inc.

Cincinnati, Ohio, 45219

Clinical Inquest Center, Springfield, Ohio

Status

Withdrawn

Address

Clinical Inquest Center

Springfield, Ohio, 45503

Central Sooner Research, Norman, Oklahoma

Status

Active, not recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

Digestive Disease Specialists (DDSI), Oklahoma City, Oklahoma

Status

Active, not recruiting

Address

Digestive Disease Specialists (DDSI)

Oklahoma City, Oklahoma, 73112

Fontier Clinical Research, LLC, Uniontown, Pennsylvania

Status

Recruiting

Address

Fontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

724-569-8100 #209

Anderson, South Carolina

Status

Active, not recruiting

Address

Synexus Clinical Research US/Primary Care Associates

Anderson, South Carolina, 29621

Synexus Clinical Research, Inc, Anderson, South Carolina

Status

Active, not recruiting

Address

Synexus Clinical Research, Inc

Anderson, South Carolina, 29621

Synexus Clinical Research US - Greer, Greer, South Carolina

Status

Active, not recruiting

Address

Synexus Clinical Research US - Greer

Greer, South Carolina, 29651

GIA Clinical Trials, LLC, Knoxville, Tennessee

Status

Active, not recruiting

Address

GIA Clinical Trials, LLC

Knoxville, Tennessee, 37909

PharmaTex Research, Amarillo, Texas

Status

Active, not recruiting

Address

PharmaTex Research

Amarillo, Texas, 79106

Mesa Research, Austin, Texas

Status

Active, not recruiting

Address

Mesa Research

Austin, Texas, 78750

ClinRX Research Joseph INC, Carrollton, Texas

Status

Active, not recruiting

Address

ClinRX Research Joseph INC

Carrollton, Texas, 75007

Synexus Clinical Research US - Dallas, Dallas, Texas

Status

Active, not recruiting

Address

Synexus Clinical Research US - Dallas

Dallas, Texas, 75234

Vilo Research Group, Houston, Texas

Status

Recruiting

Address

Vilo Research Group

Houston, Texas, 77017

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

832-660-5095

UT Health, Houston, Texas

Status

Active, not recruiting

Address

UT Health

Houston, Texas, 77030

Centex Studies, Inc. - Houston, Houston, Texas

Status

Recruiting

Address

Centex Studies, Inc. - Houston

Houston, Texas, 77058

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

281-282-0808

Discovery Clinical Trials, McAllen, Texas

Status

Withdrawn

Address

Discovery Clinical Trials

McAllen, Texas, 78503

DCT-AACT DBA Discovery Clinical Trials, Pflugerville, Texas

Status

Active, not recruiting

Address

DCT-AACT DBA Discovery Clinical Trials

Pflugerville, Texas, 78660

Gastroenterology of San Antonio, San Antonio, Texas

Status

Active, not recruiting

Address

Gastroenterology of San Antonio

San Antonio, Texas, 78229

Discovery Clinical Trials, San Antonio, Texas

Status

Recruiting

Address

Discovery Clinical Trials

San Antonio, Texas, 78230

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

210-764-4842

Advanced Research Institute, South Ogden, Utah

Status

Recruiting

Address

Advanced Research Institute

South Ogden, Utah, 84405

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

801-409-2040

Clinical Research Partners, Richmond, Virginia

Status

Active, not recruiting

Address

Clinical Research Partners

Richmond, Virginia, 23235

International Sites

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 1W9

GI Research Institute (G.I.R.I.), Vancouver, British Columbia, Canada

Status

Withdrawn

Address

GI Research Institute (G.I.R.I.)

Vancouver, British Columbia, V6Z 2K5

Barrie Endoscopy, Barrie, Ontario, Canada

Status

Not yet recruiting

Address

Barrie Endoscopy

Barrie, Ontario, L4M 7G1

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Status

Not yet recruiting

Address

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6

Humber River Hospital, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Humber River Hospital

Toronto, Ontario, M3M 0B2

Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Toronto Western Hospital/University Health Network

Toronto, Ontario, M5T 2S8

Toronto Digestive Disease Associates Inc, Vaughan, Ontario, Canada

Status

Active, not recruiting

Address

Toronto Digestive Disease Associates Inc

Vaughan, Ontario, L4L 4Y7

Fundacion de Investigation de Diego, San Juan, Puerto Rico

Status

Active, not recruiting

Address

Fundacion de Investigation de Diego

San Juan, , 00927

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