An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Study Purpose

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and 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 16 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however, participants enrolled in Stage 1 will not be permitted to enroll in Stage 2.

Inclusion Criteria:

  • - Aged 16 to 80 years, inclusive, at Screening.
For participants less than 18 years of age, the participant must weigh at least 40 kg
  • - Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to screening - Moderately to severely active Crohn's Disease

    Exclusion Criteria:

    - Participant is unable or unwilling to have endoscopic procedures performed during the study.
  • - History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
  • - Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to screening.
  • - Participant has known history of drug (including opiates) or alcohol abuse.
  • - Currently enrolled in another investigational device or drug study.
  • - Participant is pregnant, breastfeeding, or plans to become pregnant during the study.

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.

NCT03759288
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/Phase 3
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, DO
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.

Crohn's Disease, IBD
Arms & Interventions

Arms

Experimental: (Stage 1) Brazikumab high dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Experimental: (Stage 1) Brazikumab low dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous brazikumab on Day 85 and every 4 weeks through Week 48

Active Comparator: (Stage 1) Humira®

Subcutaneous Humira® on Day 1, Day 15, Day 29 and every 2 weeks through Week 50

Placebo Comparator: (Stage 1) Placebo

Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 2 weeks through Week 50

Experimental: (Stage 2) Brazikumab high dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Experimental: (Stage 2) Brazikumab low dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab 240 on Day 85 and every 4 weeks through Week 48

Active Comparator: (Stage 2) Humira®

Subcutaneous Humira® on Day 1, Day 15, Day 29 and every 2 weeks through Week 50

Interventions

Drug: - Brazikumab low dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous brazikumab on Day 85 and every 4 weeks through Week 48

Drug: - Brazikumab high dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous brazikumab on Day 85 and every 4 weeks through Week 48

Drug: - Humira®

Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.

Drug: - Placebo

Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 2 weeks through Week 50

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.

Shapiro Michael S MD, Scottsdale, Arizona

Status

Active, not recruiting

Address

Shapiro Michael S MD

Scottsdale, Arizona, 85258

Applied Research Center of Arkansas, Little Rock, Arkansas

Status

Active, not recruiting

Address

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212

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

VVCRD Research, Garden Grove, California

Status

Active, not recruiting

Address

VVCRD Research

Garden Grove, California, 92845

Om Research LLC, Lancaster, California

Status

Recruiting

Address

Om Research LLC

Lancaster, California, 93534

Clinical Trials Research, Lincoln, California

Status

Recruiting

Address

Clinical Trials Research

Lincoln, California, 95648

United Medical Doctors, Los Alamitos, California

Status

Active, not recruiting

Address

United Medical Doctors

Los Alamitos, California, 90720

Gastrointestinal Biosciences, Los Angeles, California

Status

Active, not recruiting

Address

Gastrointestinal Biosciences

Los Angeles, California, 90067

Clinical Trials Specialist, Los Angeles, California

Status

Active, not recruiting

Address

Clinical Trials Specialist

Los Angeles, California, 90211

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

Clinical Applications Laboratories, Inc, San Diego, California

Status

Active, not recruiting

Address

Clinical 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

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

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

Top Medical Research, Cutler Bay, Florida

Status

Recruiting

Address

Top Medical Research

Cutler Bay, Florida, 33189

Prohealth Research Center, Doral, Florida

Status

Active, not recruiting

Address

Prohealth Research Center

Doral, Florida, 33166

Wellness Clinical Research, Hialeah, Florida

Status

Recruiting

Address

Wellness Clinical Research

Hialeah, Florida, 33012

SIH Research, Kissimmee, Florida

Status

Active, not recruiting

Address

SIH Research

Kissimmee, Florida, 34741

C&R Research Services USA, Lake Worth, Florida

Status

Active, not recruiting

Address

C&R Research Services USA

Lake Worth, Florida, 33461

Auzmer Research, Lakeland, Florida

Status

Recruiting

Address

Auzmer Research

Lakeland, Florida, 33813

Sanchez Clinical Research, Inc, Miami, Florida

Status

Recruiting

Address

Sanchez Clinical Research, Inc

Miami, Florida, 33157

Miami, Florida

Status

Recruiting

Address

Medical Professional Clinical Research Center, INC.

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

Advanced Research Institute, Inc., Saint Petersburg, Florida

Status

Recruiting

Address

Advanced Research Institute, Inc.

Saint Petersburg, Florida, 33710

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, 33762

Atlanta, Georgia

Status

Active, not recruiting

Address

Atlanta Center for Gastroenterology and Atlanta Endoscopy Center

Atlanta, Georgia, 30030

Agile Clinical Research Trials, Atlanta, Georgia

Status

Active, not recruiting

Address

Agile Clinical Research Trials

Atlanta, Georgia, 30328

Atlanta Gastroenterology Specialists, Suwanee, Georgia

Status

Active, not recruiting

Address

Atlanta Gastroenterology Specialists

Suwanee, Georgia, 30024

Northwest Gastroenterology Group, Arlington Heights, Illinois

Status

Active, not recruiting

Address

Northwest Gastroenterology Group

Arlington Heights, Illinois, 60005

Illinois Gastroenterology Group, LLC, Gurnee, Illinois

Status

Active, not recruiting

Address

Illinois Gastroenterology Group, LLC

Gurnee, Illinois, 60031

Investigators Research Group, LLC, Brownsburg, Indiana

Status

Active, not recruiting

Address

Investigators Research Group, LLC

Brownsburg, Indiana, 46112

Aquaint Research, New Albany, Indiana

Status

Recruiting

Address

Aquaint Research

New Albany, Indiana, 47150

Ideal Health, Shawnee Mission, Kansas

Status

Active, not recruiting

Address

Ideal Health

Shawnee Mission, Kansas, 66226

Kansas Medical Clinic, Topeka, Kansas

Status

Recruiting

Address

Kansas Medical Clinic

Topeka, Kansas, 66606

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

Clinical Research Institute of Michigan, Chesterfield, Michigan

Status

Active, not recruiting

Address

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047

Detroit Clinical Research Center, Farmington Hills, Michigan

Status

Active, not recruiting

Address

Detroit Clinical Research Center

Farmington Hills, Michigan, 48334

Biloxi, Mississippi

Status

Withdrawn

Address

Gen 1 Research - National Diabetes and Obesity Research Institute

Biloxi, Mississippi, 35932

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

Trialspark, Astoria, New York

Status

Withdrawn

Address

Trialspark

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

Manhattan Medical Research, New York, New York

Status

Withdrawn

Address

Manhattan Medical Research

New York, New York, 10012

Manhattan Medical Research, New York, New York

Status

Active, not recruiting

Address

Manhattan Medical Research

New York, New York, 10016

Trialspark, New York, New York

Status

Withdrawn

Address

Trialspark

New York, New York, 10016

Lucas Research, Morehead City, North Carolina

Status

Withdrawn

Address

Lucas Research

Morehead City, North Carolina, 28557

Great Lakes Medical Research, LLC, Beachwood, Ohio

Status

Active, not recruiting

Address

Great Lakes Medical Research, LLC

Beachwood, Ohio, 44122

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

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, 68048

Synexus Clinical Research US - Greer, Greer, South Carolina

Status

Active, not recruiting

Address

Synexus Clinical Research US - Greer

Greer, South Carolina, 29651

East Tennessee Research Institute, Johnson City, Tennessee

Status

Active, not recruiting

Address

East Tennessee Research Institute

Johnson City, Tennessee, 37604

GIA Clinical Trials, Knoxville, Tennessee

Status

Active, not recruiting

Address

GIA Clinical Trials

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

Vilo Research Group, Houston, Texas

Status

Recruiting

Address

Vilo Research Group

Houston, Texas, 77017

Sensible Healthcare, Houston, Texas

Status

Recruiting

Address

Sensible Healthcare

Houston, Texas, 77058

McAllen, Texas

Status

Withdrawn

Address

DCT-McAllen Primary Care DBA 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

San Antonio, Texas

Status

Recruiting

Address

DCT Stone Oak DBA Discovery Clinical Trials

San Antonio, Texas, 78258

Advanced Research Institute, South Ogden, Utah

Status

Recruiting

Address

Advanced Research Institute

South Ogden, Utah, 84405

Clinical Research Partners, Richmond, Virginia

Status

Active, not recruiting

Address

Clinical Research Partners

Richmond, Virginia, 23235

International Sites

Toronto Digestive Disease Associates Inc, Vaughan, Ontario, Canada

Status

Active, not recruiting

Address

Toronto Digestive Disease Associates Inc

Vaughan, Ontario, L4L 4Y7

Fundación de Investigación de Diego, San Juan, Puerto Rico

Status

Active, not recruiting

Address

Fundación de Investigación de Diego

San Juan, , 00927

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