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 Canada, 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.

Clinical Research Partners, Richmond, Virginia

Status

Recruiting

Address

Clinical Research Partners

Richmond, Virginia, 23235

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

804-308-8659

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

ClinRX Research Joseph INC, Carrollton, Texas

Status

Recruiting

Address

ClinRX Research Joseph INC

Carrollton, Texas, 75007

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

214-509-8924

PharmaTex Research, Amarillo, Texas

Status

Recruiting

Address

PharmaTex Research

Amarillo, Texas, 79106

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

Digestive Disease Specialists (DDSI), Oklahoma City, Oklahoma

Status

Recruiting

Address

Digestive Disease Specialists (DDSI)

Oklahoma City, Oklahoma, 73112

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

405-702-1246

Central Sooner Research, Norman, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

405-843-0374

Clinical Inquest Center, Springfield, Ohio

Status

Recruiting

Address

Clinical Inquest Center

Springfield, Ohio, 45503

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

937-429-2422

Consultants for Clinical Research, Inc., Cincinnati, Ohio

Status

Withdrawn

Address

Consultants for Clinical Research, Inc.

Cincinnati, Ohio, 45219

Lucas Research, Morehead City, North Carolina

Status

Recruiting

Address

Lucas Research

Morehead City, North Carolina, 28571

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

252-222-5700 #110

Trialspark, Inc., New York, New York

Status

Withdrawn

Address

Trialspark, Inc.

New York, New York, 10016

Manhattan Medical Research Practice PLLC, New York, New York

Status

Recruiting

Address

Manhattan Medical Research Practice PLLC

New York, New York, 10016

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

917-409-3932

Trialspark, Inc., New York, New York

Status

Recruiting

Address

Trialspark, Inc.

New York, New York, 10012

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

860-740-2854

Trialspark, Inc., Brooklyn, New York

Status

Recruiting

Address

Trialspark, Inc.

Brooklyn, New York, 11235

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

718-854-5100

Trialspark, Inc., Brooklyn, New York

Status

Recruiting

Address

Trialspark, Inc.

Brooklyn, New York, 11218

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

860-556-1686

Trialspark, Inc., Astoria, New York

Status

Recruiting

Address

Trialspark, Inc.

Astoria, New York, 11104

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

718-729-4470

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

Advanced Biomedical Research of America, Las Vegas, Nevada

Status

Recruiting

Address

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

702-898-2088

Jubilee Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

Jubilee Clinical Research

Las Vegas, Nevada, 89106

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

702-631-5000

Biloxi, Mississippi

Status

Recruiting

Address

Gen 1 Research - National Diabetes and Obesity Research Institute

Biloxi, Mississippi, 39532

The Center for Clinical Trials, Biloxi, Mississippi

Status

Recruiting

Address

The Center for Clinical Trials

Biloxi, Mississippi, 39531

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

228-388-3112

Tandem Clinical Research, Marrero, Louisiana

Status

Recruiting

Address

Tandem Clinical Research

Marrero, Louisiana, 70072

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

504-934-8424

Gastroenterology Associates, LLC, Baton Rouge, Louisiana

Status

Recruiting

Address

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, 70809

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

225-231-8783

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

Investigators Research Group, LLC, Brownsburg, Indiana

Status

Recruiting

Address

Investigators Research Group, LLC

Brownsburg, Indiana, 46112

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

317-852-8280

Illinois Gastroenterology Group, Gurnee, Illinois

Status

Recruiting

Address

Illinois Gastroenterology Group

Gurnee, Illinois, 60031

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

847-244-2960

Atlanta Gastroenterology Specialists, Suwanee, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Specialists

Suwanee, Georgia, 30024

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

678-957-0057

Gastro Florida, Tampa, Florida

Status

Recruiting

Address

Gastro Florida

Tampa, Florida, 33626

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

727-827-7685

Guardian Angel Research Center, Tampa, Florida

Status

Recruiting

Address

Guardian Angel Research Center

Tampa, Florida, 33614

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

813-512-7479

Advanced Research, Inc, New Port Richey, Florida

Status

Recruiting

Address

Advanced Research, Inc

New Port Richey, Florida, 34653

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

727-835-3261

Valencia Medial & Research Center, Miami, Florida

Status

Recruiting

Address

Valencia Medial & Research Center

Miami, Florida, 33165

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

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

C&R Research Services, Lake Worth, Florida

Status

Recruiting

Address

C&R Research Services

Lake Worth, Florida, 33461

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

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

American Research Institute, Cutler Bay, Florida

Status

Withdrawn

Address

American Research Institute

Cutler Bay, Florida, 33157

Clearwater, Florida

Status

Recruiting

Address

Gastroenterology Consultants of Clearwater

Clearwater, Florida, 33756

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

727-827-7685

Plasma Med Research, Boca Raton, Florida

Status

Recruiting

Address

Plasma Med Research

Boca Raton, Florida, 33487

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

561-717-5210

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

Clinical Trials Research, Wayne, California

Status

Recruiting

Address

Clinical Trials Research

Wayne, California, 95648

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

916-434-8230

Care Access Research, San Pablo, California

Status

Recruiting

Address

Care Access Research

San Pablo, California, 94806

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

510-255-0642

Ritchken & First MD's, San Diego, California

Status

Withdrawn

Address

Ritchken & First MD's

San Diego, California, 92117

Lomita Family Medical Group, Inc, San Diego, California

Status

Withdrawn

Address

Lomita Family Medical Group, Inc

San Diego, California, 92114

Clincal Applications Laboratories, Inc., San Diego, California

Status

Recruiting

Address

Clincal Applications Laboratories, Inc.

San Diego, California, 92103

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

619-260-1012

Breakthrough Clinical Trials, LLC, San Bernardino, California

Status

Recruiting

Address

Breakthrough Clinical Trials, LLC

San Bernardino, California, 92408

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

909-890-9222

ACRC Studies, Poway, California

Status

Recruiting

Address

ACRC Studies

Poway, California, 92064

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

619-861-5314

Gastroinestinal Biosciences, Los Angeles, California

Status

Recruiting

Address

Gastroinestinal Biosciences

Los Angeles, California, 90036

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

310-282-0525

United Medical Doctors, Los Alamitos, California

Status

Recruiting

Address

United Medical Doctors

Los Alamitos, California, 90720

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

951-566-5229

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

VVCRD Clinical Research, Garden Grove, California

Status

Recruiting

Address

VVCRD Clinical Research

Garden Grove, California, 92845

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

855-229-1665 #2

eStudySite, Chula Vista, California

Status

Recruiting

Address

eStudySite

Chula Vista, California, 91911

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

619-955-5246

Ventura Gastroenterolgy Medical Group, Camarillo, California

Status

Recruiting

Address

Ventura Gastroenterolgy Medical Group

Camarillo, California, 93012

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

805-483-1185

Applied Research Center of Arkansas, Little Rock, Arkansas

Status

Recruiting

Address

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212

Site Contact

Study Coordinator

IR‐CTRegistration@Allergan.com

501-954-7822

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

International Sites

Toronto Digestive Disease Associates Inc, Vaughan, Ontario, Canada

Status

Not yet recruiting

Address

Toronto Digestive Disease Associates Inc

Vaughan, Ontario, L4L 4Y7

Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Toronto Western Hospital/University Health Network

Toronto, Ontario, M5T 2S8

Humber River Hospital, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Humber River Hospital

Toronto, Ontario, M3M 0B2

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Status

Not yet recruiting

Address

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6

Barrie Endoscopy, Barrie, Ontario, Canada

Status

Not yet recruiting

Address

Barrie Endoscopy

Barrie, Ontario, L4M 7G1

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

Status

Not yet recruiting

Address

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

Vancouver, British Columbia, V6Z 2K5

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 1W9

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