A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

Study Purpose

The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

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 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Has an adequate comprehension of a gluten-free diet (GFD) assessed by the site investigator after review of responses to a knowledge test. The final determination of a participant's adequate comprehension of a GFD is at the discretion of the investigator. 2. Has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to gluten exposure. The CeD-related symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE). 3. Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant. 4. Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4. 5. The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive. 6. The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator. 7. Have a body mass index (BMI) between 16 and 45 kilogram per meter square (kg/m^2), inclusive. Note: Individuals with BMI of 40 to 45 should be discussed with the medical monitor and confirmed to be appropriate for endoscopy according to local site guidelines. 8. The participant is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the first visit (Visit 1). There should be no changes to diet, medications (prescription or over-the-counter) or supplements during study participation.

Exclusion Criteria:

1. Has the presence of other inflammatory GI disorders or systemic autoimmune diseases that either have the potential to cause persistent GI symptoms similar to CeD or are not well controlled without the use of excluded medication.
  • - Examples of conditions that are exclusionary include inflammatory bowel disease, eosinophilic esophagitis, gastroenteritis or colitis, microscopic colitis diagnosed at screening or requiring treatment in the 6 months before screening.
  • - Examples of conditions that may be permissible after discussion with the medical monitor include systemic autoimmune disease such as scleroderma, psoriatic or rheumatoid arthritis, or lupus that is stable and without GI involvement; well controlled autoimmune thyroid disease; well-controlled type 1 diabetes; or proton pump inhibitor (PPI) responsive eosinophilic esophagitis in symptomatic and histologically confirmed remission.
2. Has ongoing systemic immunosuppressant, systemic corticosteroid treatment excluding medication given for the endoscopies, or treatment with systemic immunosuppressants or systemic corticosteroids in the 12 weeks before Screening. • The participant is receiving immunosuppressive doses of corticosteroids: 3 mg per day or more of budesonide for more than 3 consecutive days within 3 months before Screening, more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 90 days before the first dose, any dose of oral or intravenous (IV) corticosteroids within 30 days of the first dose, or high-dose inhaled corticosteroids (>960 micrograms per day [μg/day] of beclomethasone dipropionate or equivalent), or other systemic immunosuppressive agents. 3. Has ongoing use of over-the-counter digestive enzymes or digestive supplements, other than lactase, including those for gluten digestion. Probiotics are allowable if they were started before Screening and not discontinued or changed in dose or type during the study. 4. Has completed the CDSD on ≤75% of the evaluable days during the run-in period until randomization. 5. Has active microscopic colitis requiring treatment in the 6 months before Screening. • Microscopic colitis detected at screening if sigmoidoscopy is performed would exclude the participant. 6. Has known or suspected type 2 refractory CeD or ulcerative jejunitis. 7. Has ongoing chronic use (defined as >7 days continuous use) of a nonsteroidal anti-inflammatory drug aside from <100 mg aspirin, daily, for prophylactic use. 8. Has ongoing use, or use in the 3 months before screening, of medications known to cause villous abnormalities (e.g., mycophenolate mofetil, angiotensin receptor blockers, colchicine). 9. Has used treatments for GI symptoms including antiemetics, antidiarrheals, antispasmodics, medical marijuana, (use of medical marijuana indicated for non-GI conditions is not exclusionary) within 2 weeks of Screening and during the run-in period. Participants on stable dose (i.e., more than 4 weeks) of an osmotic, bulking-forming or emollient (surface active agent) laxative are eligible, provided symptoms are considered not related to CeD in the opinion of the investigator. 10. Has a known or suspected severe enteric infection (viral, bacterial, or parasitic) within 6 months before randomization. Severe enteric infection is defined as requiring emergency room visit or hospitalization or treatment with antibiotics or anti-infectives due to infection. Non enteric viral infections, either resolved or well-controlled are not exclusionary. 11. Has a contraindication to endoscopy with duodenal biopsy. --Contraindication to VCE (strictures, anastomoses, etc) is not an exclusion if the participant is able to complete the other aspects of the study. 12. Has additional food allergies (tapioca syrup, oats, almonds, rice crisp, chocolate, almond, butter, wheat gluten, cocoa butter, oat flour, glycerin, sunflower lecithin, salt, and natural flavors) to nongluten ingredients in the SIGE bar study food or significant symptoms upon ingestion of the gluten-free SIGE bar during screening. 13. Has a history of intolerance, hypersensitivity, or idiosyncratic reaction to an aminoglycoside. 14. Has a known human immunodeficiency virus (HIV) infection or positive tests for hepatitis B or C. The participant has a known clinically significant chronically active hepatopathy of any origin, including cirrhosis, and participants with persistent positive hepatitis B virus surface antigen and quantitative hepatitis B virus polymerase chain reaction (PCR), or positive serology for hepatitis C virus (HCV) and quantitative HCV PCR within 6 months before the screening visit. 15. Is positive for severe acute respiratory syndrome coronavirus 2 at the time of screening and exhibits symptoms that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of study outcomes or safety. 16. Has a known hypersensitivity reaction and/or allergy, including anaphylaxis, to wheat and/or gluten. 17. Has known history of hypersensitivity, idiosyncratic reaction, or intolerance to any ingredients or excipients in TAK-062 and/or placebo. 18. The participant has a current diagnosis of active malignancy or is receiving treatment for active malignancy (hormone therapy alone is not exclusionary). Participants with fully resected Stage 0 (carcinoma in situ) or Stage 1 tumor without signs of recurrence may participate. All other individuals with malignancies diagnosed in the 5 years prior to screening are excluded. Region-specific

Exclusion Criteria:

18. Participant enrolling in a study in France is not affiliated to a social security scheme or a beneficiary of such a scheme. 19. Participant enrolling in a study in France is deprived of their liberty by a judicial or administrative decision.

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.

NCT05353985
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.

Takeda
Principal Investigator

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

Study Director
Principal Investigator Affiliation Takeda
Agency Class

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

Industry
Overall Status Recruiting
Countries Belgium, Canada, France, Italy, Poland, Spain, United Kingdom, United States
Conditions

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

Celiac Disease
Additional Details

The drug being tested in this study is called TAK-062. TAK-062 is designed to break down gluten in the stomach and is being tested to treat people who have active CeD, attempting to maintain a GFD. The study will enroll approximately 357 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1: 1. Cohort 1 (Age 18 and older): TAK-062 Placebo + SIGE Gluten-Bar. 2. Cohort 1 (Age 18 and older): TAK-062 Dose 1 + SIGE Gluten-Bar. After the interim analysis (IA), Cohort 1 data will be reviewed by an external independent data monitoring committee (DMC), and based on the Sponsor's decision, adolescent participants will be enrolled in Cohort 2. Adult participants, 18 years and older will be enrolled into Cohort 2 once Cohort 1 has completed enrolment. Adult participants will be randomly assigned to one of the five study drug and SIGE treatment groups (Groups a-e), and approximately 21 adolescent participants will be enrolled and randomly assigned to Groups d, e, and f (adolescents only). Adolescents in Cohort 2 will receive only gluten-free SIGE bars. 1. Cohort 2 (Age 18 and older): TAK-062 Placebo + SIGE Gluten-Bar. 2. Cohort 2 (Age 18 and older): TAK-062 Dose 2 + SIGE Gluten-Bar. 3. Cohort 2 (Age 18 and older): TAK-062 Dose 3 + SIGE Gluten-Bar. 4. Cohort 2 (Age 12 and older): TAK-062 Placebo + Gluten-free SIGE Bar. 5. Cohort 2 (Age 12 and older): TAK-062 Dose 1 + Gluten-free SIGE Bar. 6. Cohort 2 (Age 12-17): TAK-062 Dose 2 + Gluten-free SIGE Bar. This multi-center trial will be conducted in the United States (US), Canada, United Kingdom and the European Union. The overall time to participate in this study is approximately 36 weeks.

Arms & Interventions

Arms

Placebo Comparator: Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar

TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar

TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Placebo Comparator: Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar

TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar

TAK-062 Dose 2, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar

TAK-062 Dose 3, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Placebo Comparator: Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar

TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar

TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Experimental: Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE Bar

TAK-062 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Interventions

Drug: - TAK-062

TAK-062 tablets.

Dietary Supplement: - Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

SIGE gluten bars.

Drug: - TAK-062 Placebo

TAK-062 placebo-matching tablets.

Dietary Supplement: - Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

SIGE gluten-free bars.

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.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Site Contact

Site Contact

acartee@uabmc.edu

205-996-4744

Research Solutions of Arizona, PC, Litchfield Park, Arizona

Status

Recruiting

Address

Research Solutions of Arizona, PC

Litchfield Park, Arizona, 85340

Site Contact

Site Contact

chsu@researchsolutionsaz.com

623-512-4310

Paradise Valley, Arizona

Status

Recruiting

Address

One of a Kind Clinical Research Center LLC

Paradise Valley, Arizona, 85253

Site Contact

Site Contact

fg@1-oak.net

602-820-6906

Mayo Clinic- Arizona, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic- Arizona

Scottsdale, Arizona, 85259

Site Contact

Site Contact

harris.lucinda@mayo.edu

480-301-6990

GI Alliance- Sun City, Sun City, Arizona

Status

Recruiting

Address

GI Alliance- Sun City

Sun City, Arizona, 85351

Adobe Clinical Research LLC, Tucson, Arizona

Status

Recruiting

Address

Adobe Clinical Research LLC

Tucson, Arizona, 85712

Gastroenterology and Liver Institute, Escondido, California

Status

Recruiting

Address

Gastroenterology and Liver Institute

Escondido, California, 92025

Site Contact

Site Contact

garanaveen81@gmail.com

760-690-2800

Om Research LLC, Lancaster, California

Status

Recruiting

Address

Om Research LLC

Lancaster, California, 93534

Site Contact

Site Contact

ngrover@omclinicaltrials.com

661-388-2239

Om Research LLC, Lancaster, California

Status

Recruiting

Address

Om Research LLC

Lancaster, California, 93534

Site Contact

Site Contact

jpruthi@omclinicaltrials.com

661-388-2239

Om Research LLC, Lancaster, California

Status

Recruiting

Address

Om Research LLC

Lancaster, California, 93534

Site Contact

Site Contact

k.simon@insitedigestive.com

661-388-2239

Los Angeles, California

Status

Recruiting

Address

So. California Research Institute Med Group Inc./West Gastroenterology Med Group

Los Angeles, California, 90045

Site Contact

Site Contact

a.ojuri@westgastro.com

310-674-0144

UCLA, Los Angeles, California

Status

Recruiting

Address

UCLA

Los Angeles, California, 90404

Site Contact

Site Contact

gweiss@mednet.ucla.edu

310-206-6279

Providence Facey Medical Foundation, Mission Hills, California

Status

Recruiting

Address

Providence Facey Medical Foundation

Mission Hills, California, 91345

Site Contact

Site Contact

mbeshay@facey.com

818-869-7268

Stanford University School of Medicine, Redwood City, California

Status

Recruiting

Address

Stanford University School of Medicine

Redwood City, California, 94063

Site Contact

Site Contact

nfernan1@stanford.edu

650-521-7237

Medical Associates Research Group, Inc., San Diego, California

Status

Recruiting

Address

Medical Associates Research Group, Inc.

San Diego, California, 92123

Site Contact

Site Contact

kimkim7869@sbcglobal.net

858-277-5678

Asthma and Allergy Associates, PC, Colorado Springs, Colorado

Status

Recruiting

Address

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907

Site Contact

Site Contact

dsoteres@aacos.com

719-473-0872

Hamden, Connecticut

Status

Recruiting

Address

Medical Research Center of Connecticut, LLC 300143562

Hamden, Connecticut, 06518

Site Contact

Site Contact

pfeuerstadt@gastrocenter.org

203-281-5161

Central Connecticut Endoscopy Center, Plainville, Connecticut

Status

Recruiting

Address

Central Connecticut Endoscopy Center

Plainville, Connecticut, 06062

Site Contact

Site Contact

szakko@connecticutgi.org

860-793-8500

Nature Coast Clinical Research, LLC, Inverness, Florida

Status

Recruiting

Address

Nature Coast Clinical Research, LLC

Inverness, Florida, 34452

Site Contact

Site Contact

phellstern@encoredocs.com

352-341-2100

Wellness Clinical Research, Miami Lakes, Florida

Status

Recruiting

Address

Wellness Clinical Research

Miami Lakes, Florida, 33016

University of Miami Medical Center, Miami, Florida

Status

Recruiting

Address

University of Miami Medical Center

Miami, Florida, 33136

Site Contact

Site Contact

jabarkin@miami.edu

305-689-1800

Pensacola, Florida

Status

Recruiting

Address

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, 32503

Site Contact

Site Contact

fnewman@gastrohealth.com

850-436-4563

St. Johns Center for Clinical Research, Saint Augustine, Florida

Status

Recruiting

Address

St. Johns Center for Clinical Research

Saint Augustine, Florida, 32086

Site Contact

Site Contact

bpineau@encoredocs.com

904-209-0043

GCP Clinical Research, LLC, Tampa, Florida

Status

Recruiting

Address

GCP Clinical Research, LLC

Tampa, Florida, 33609

Site Contact

Site Contact

alanw@gcpclinicalresearch.com

813-289-4321

Agile Clinical Research Trials, Alpharetta, Georgia

Status

Recruiting

Address

Agile Clinical Research Trials

Alpharetta, Georgia, 30022

Site Contact

Site Contact

drvasu@agilecrt.com

770-235-8479

Lemah Creek Clinical Research, Oakbrook Terrace, Illinois

Status

Recruiting

Address

Lemah Creek Clinical Research

Oakbrook Terrace, Illinois, 60181

Site Contact

Site Contact

kward@leccr.com

708-274-1577

Indiana University -GI, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University -GI

Indianapolis, Indiana, 46202

Site Contact

Site Contact

mofische@iu.edu

317-944-3332

University of Iowa Hospital and Clinics, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

Site Contact

Site Contact

david-elliott@uiowa.edu

319-356-4901

University Medical Center New Orleans, New Orleans, Louisiana

Status

Recruiting

Address

University Medical Center New Orleans

New Orleans, Louisiana, 70112

Site Contact

Site Contact

virendra.joshi@lcmchealth.org

504-897-8004

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Site Contact

mleonard7@mgh.harvard.edu

617-726-8705

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

Site Contact

jsilves2@bidmc.harvard.edu

617-667-8374

Lahey Hospital and Medical, Burlington, Massachusetts

Status

Recruiting

Address

Lahey Hospital and Medical

Burlington, Massachusetts, 01805

Site Contact

Site Contact

randall.pellish@lahey.org

781-744-8740

Hawthorn Medical Associates LLC, South Dartmouth, Massachusetts

Status

Recruiting

Address

Hawthorn Medical Associates LLC

South Dartmouth, Massachusetts, 02747

Site Contact

Site Contact

psepe@hawthornmed.com

508-996-3991

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Site Contact

elizwu@med.umich.edu

734-647-5944

Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

Site Contact

Site Contact

rfogel@researchmi.com

586-598-3329

Revive Research Institute, Inc, Farmington Hills, Michigan

Status

Recruiting

Address

Revive Research Institute, Inc

Farmington Hills, Michigan, 48334

Site Contact

Site Contact

cutler_alan@yahoo.com

248-564-1485

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Site Contact

Site Contact

murray.joseph@mayo.edu

+1-877-825-3327

Saint Louis, Missouri

Status

Recruiting

Address

Washington University, School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Site Contact

osamaaltayar@wustl.edu

314-747-2066

Manhattan Clinical Research, LLC, Manhattan, New York

Status

Recruiting

Address

Manhattan Clinical Research, LLC

Manhattan, New York, 10016

Site Contact

Site Contact

coneto@vanguardgi.com

212-889-5544

New York University Medical Center PRIME, New York, New York

Status

Recruiting

Address

New York University Medical Center PRIME

New York, New York, 10016

Site Contact

Site Contact

seth.gross@nyulangone.org

212-263-3095

Blair S Lewis MD, New York, New York

Status

Recruiting

Address

Blair S Lewis MD

New York, New York, 10032

Site Contact

Site Contact

skl3@cumc.columbia.edu

212-369-6600

Rochester Clinical Research, Rochester, New York

Status

Recruiting

Address

Rochester Clinical Research

Rochester, New York, 14618

Site Contact

Site Contact

jgoldstein@rcrclinical.com

585-271-2800

Tryon Medical Partners, Charlotte, North Carolina

Status

Recruiting

Address

Tryon Medical Partners

Charlotte, North Carolina, 28210

Site Contact

Site Contact

cferris@tryonmed.com

704-489-3094

Carolina Digestive Diseases, Greenville, North Carolina

Status

Recruiting

Address

Carolina Digestive Diseases

Greenville, North Carolina, 27834

Site Contact

Site Contact

pgoldstein@cddgastro.com

252-758-8181

Gastro Health Research, Cincinnati, Ohio

Status

Recruiting

Address

Gastro Health Research

Cincinnati, Ohio, 45219

Site Contact

Site Contact

pbekal@gastrohealth.com

513-751-6667

Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic - Gastroenterology and Hepatology

Cleveland, Ohio, 44195

Site Contact

Site Contact

rubiota@ccf.org

216-445-7015

Dayton Gastroenterology, Inc, Englewood, Ohio

Status

Recruiting

Address

Dayton Gastroenterology, Inc

Englewood, Ohio, 45415

Site Contact

Site Contact

aknoll@daytongastro.com

937-320-5050

Allentown, Pennsylvania

Status

Recruiting

Address

Eastern Pennsylvania Gastroeneterology and Liver Specialists

Allentown, Pennsylvania, 18104

Site Contact

Site Contact

allison.baragona@gmail.com

610-821-2828 #203

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Site Contact

stephanie.moleski@jefferson.edu

215-955-8900

Gastroenterology Associates, PA, Greenville, South Carolina

Status

Recruiting

Address

Gastroenterology Associates, PA

Greenville, South Carolina, 29607

Site Contact

Site Contact

mbarnesmd@gastroassociates.com

864-232-7338

Rapid City Medical Center, LLC, Rapid City, South Dakota

Status

Recruiting

Address

Rapid City Medical Center, LLC

Rapid City, South Dakota, 57701

Site Contact

Site Contact

gitex66@gmail.com

605-342-3280

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Site Contact

dawn.w.adams@vumc.org

615-936-0128

The Methodist Hospital 150520246, Houston, Texas

Status

Recruiting

Address

The Methodist Hospital 150520246

Houston, Texas, 77030

Site Contact

Site Contact

equigley@houstonmethodist.org

713-441-0853

Biopharma Informatic, LLC, Houston, Texas

Status

Recruiting

Address

Biopharma Informatic, LLC

Houston, Texas, 77084

Site Contact

Site Contact

jmaher@biopharmainfo.net

281-945-5190

Spring Clinical Research, Houston, Texas

Status

Terminated

Address

Spring Clinical Research

Houston, Texas, 77090

Biopharma Informatic, LLC, McAllen, Texas

Status

Recruiting

Address

Biopharma Informatic, LLC

McAllen, Texas, 78503

Site Contact

Site Contact

ralph@biopharmainfo.net

956-661-9300

Victoria Gastroenterology, Victoria, Texas

Status

Recruiting

Address

Victoria Gastroenterology

Victoria, Texas, 77904

Site Contact

Site Contact

dharmendrav.ppr@gmail.com

361-485-2695

University of Virginia Medical Center, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia Medical Center

Charlottesville, Virginia, 22903

Site Contact

Site Contact

dk3mb@uvahealth.org

434-924-2959

Blue Ridge Medical Research, Lynchburg, Virginia

Status

Recruiting

Address

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

Site Contact

Site Contact

l.clark@gastrocentralva.com

434-384-1862

Clinical Research Partners, LLC, Richmond, Virginia

Status

Recruiting

Address

Clinical Research Partners, LLC

Richmond, Virginia, 23220

Site Contact

Site Contact

rcallmd@clinicalresearchrva.com

804-477-3045

Swedish Gastroenterology, Seattle, Washington

Status

Recruiting

Address

Swedish Gastroenterology

Seattle, Washington, 98104

Site Contact

Site Contact

karlee.ausk@swedish.org

206-215-4250

Seattle, Washington

Status

Recruiting

Address

University of Washington Division of Gastroenterology

Seattle, Washington, 98195

Site Contact

Site Contact

isabelh@medicine.washington.edu

206-897-1821

Velocity Clinical Research, Spokane, Washington

Status

Recruiting

Address

Velocity Clinical Research

Spokane, Washington, 99218

Site Contact

Site Contact

ssmiley@velocityclinical.com

512-388-5717

International Sites

AZ Sint-Lucas, Brugge, Belgium

Status

Recruiting

Address

AZ Sint-Lucas

Brugge, , 8310

Site Contact

Site Contact

joris.arts@stlucas.be

325-036-5155

AZ Maria Middelares, Gent, Belgium

Status

Recruiting

Address

AZ Maria Middelares

Gent, , 9000

Site Contact

Site Contact

didier.baert@mijnziekenhuis.be

329-246-7100

Vitaz, Sint-Niklaas, Belgium

Status

Recruiting

Address

Vitaz

Sint-Niklaas, , 9100

Site Contact

Site Contact

tom.holvoet@aznikolaas.be

323-760-2934

Edmonton, Alberta, Canada

Status

Recruiting

Address

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta, T5R 1W2

Site Contact

Site Contact

allen@giresearch.ca

7804991192

Winnipeg, Manitoba, Canada

Status

Recruiting

Address

St. Boniface Hospital Inc. Section of Nephrology BG 007

Winnipeg, Manitoba, R2H 2A6

Site Contact

Site Contact

duerksn@cc.umanitoba.ca

2042372796

Kensington Screening Clinic, Toronto, Ontario, Canada

Status

Recruiting

Address

Kensington Screening Clinic

Toronto, Ontario, M5T 3A9

Site Contact

Site Contact

ian@gibookman.com

(416) 928-1335 x3436

Toulouse Cedex 09, Haute Garonne, France

Status

Recruiting

Address

Hopital Rangueil Service de Gastro Enterologie et Nutrition

Toulouse Cedex 09, Haute Garonne, 31059

Site Contact

Site Contact

bournet.b@chu-toulouse.fr

33561323235

Institut des MICI, Neuilly, Hauts De Seine, France

Status

Recruiting

Address

Institut des MICI

Neuilly, Hauts De Seine, 92200

Site Contact

Site Contact

yoram.bouhnik@institutdesmici.fr

33140875630

Saint Etienne, Loire, France

Status

Recruiting

Address

CHU Saint Etienne - Hopital Nord Service de Gastro-Enterologie et Hepatologie

Saint Etienne, Loire, 42055

Site Contact

Site Contact

xavier.roblin@chu-st-etienne.fr

33477828320

Lille cedex, Nord, France

Status

Recruiting

Address

CHU Lille - Hopital Claude Huriez Service des maladies de I'appareil digestif

Lille cedex, Nord, 59037

Site Contact

Site Contact

julien.branche@chru-lille.fr

33320444714

Paris, France

Status

Recruiting

Address

Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive

Paris, , 75015

Site Contact

Site Contact

christophe.cellier@aphp.fr

33156093552

Milan, Milano, Italy

Status

Recruiting

Address

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Milano, 20122

Site Contact

Site Contact

luca.elli@policlinico.mi.it

39932768111

Ancona, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Ospedali Riuniti- Ospedale Pediatrico UOC Pediatria - G. Salesi

Ancona, , 60123

Site Contact

Site Contact

c.catassi@univpm.it

39715962364

Ospedale Valduce 300205849, Como, Italy

Status

Recruiting

Address

Ospedale Valduce 300205849

Como, , 22100

Site Contact

Site Contact

ema.rondo@gmail.com

3931324111

Palermo, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine

Palermo, , 90127

Site Contact

Site Contact

pasquale.mansueto@unipa.it

390916554347

Pavia, Italy

Status

Recruiting

Address

Fondazione IRCCS Policlinico San Matteo Sezione di Medicina Interna

Pavia, , 27100

Site Contact

Site Contact

a.disabatino@smatteo.pv.it

39382502973

Pisa, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) U.O. Gastroenterologia

Pisa, , 56124

Site Contact

Site Contact

g.mumolo@int.med.unipi.it

393479389231

Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia

Roma, , 168

Salerno, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

Salerno, , 84131

Site Contact

Site Contact

cciacci@unisa.it

3989965032

Torino, Italy

Status

Recruiting

Address

Ospedale Umberto I di Torino S.C. Gastroenterologia

Torino, , 10128

Site Contact

Site Contact

lcrocella@libero.it

393476825921

Krakow, Poland

Status

Recruiting

Address

FutureMeds Krakow prev. Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, , 31-501

Site Contact

Site Contact

piotr.rozpondek@futuremeds.com

48124303209

ALLMEDICA sp. z o. o., Nowy Targ, Poland

Status

Recruiting

Address

ALLMEDICA sp. z o. o.

Nowy Targ, , 34-400

Site Contact

Site Contact

mikolaj.krzyzanowski@gmail.com

48184791098

Gabinet Lekarski Bartosz Korczowski, Rzeszow, Poland

Status

Recruiting

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszow, , 35-302

Site Contact

Site Contact

korczowski@op.pl

48604481752

Centrum Medyczne Medyk, Rzeszow, Poland

Status

Recruiting

Address

Centrum Medyczne Medyk

Rzeszow, , 35-326

Site Contact

Site Contact

r.filip.medyk@gmail.com

48509130097

Warsaw IBD Point Profesor Kierkus, Warszawa, Poland

Status

Recruiting

Address

Warsaw IBD Point Profesor Kierkus

Warszawa, , 00-728

Site Contact

Site Contact

j.kierkus@wip.waw.pl

48500111648

Warszawa, Poland

Status

Recruiting

Address

Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie

Warszawa, , 02-172

Site Contact

Site Contact

mmurawski@pratia.pl

48502099937

Melita Medical SP . Z O. O., Wroclaw, Poland

Status

Recruiting

Address

Melita Medical SP . Z O. O.

Wroclaw, , 50-449

Site Contact

Site Contact

j.leszczyszyn@melitamedical.pl

48661302302

ETG Zamosc, Zamosc, Poland

Status

Recruiting

Address

ETG Zamosc

Zamosc, , 22-400

Site Contact

Site Contact

k.wojcik@etg-network.com

48722222288

Vall d'Hebron Research Institute, Barcelona, Spain

Status

Recruiting

Address

Vall d'Hebron Research Institute

Barcelona, , 8035

Site Contact

Site Contact

beatriz.lobo@vallhebron.cat

+34934894035 x36

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramon y Cajal Servicio de Gastroenterologia

Madrid, , 28034

Site Contact

Site Contact

lcreper@yahoo.es

34699097205

Malaga, Spain

Status

Recruiting

Address

Hospital Clinico Universitario Virgen de la Victoria Digestive Service

Malaga, , 29010

Site Contact

Site Contact

andrade@uma.es

34951032058

Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Macarena Digestive Service

Sevilla, , 41009

Site Contact

Site Contact

farguelles@telefonica.net

34617348501

Zaragoza, Spain

Status

Recruiting

Address

Hospital Universitario Miguel Servet Servicio de Aparato Digestivo

Zaragoza, , 50009

Site Contact

Site Contact

cjimenoayllon@yahoo.es

34976765526

London, Greater London, United Kingdom

Status

Recruiting

Address

Royal London Hospital Dept of Gastroenterology

London, Greater London, E1 1FR

Site Contact

Site Contact

q.aziz@qmul.ac.uk

442073777486

London, Greater London, United Kingdom

Status

Recruiting

Address

King's College Hospital Dept of Gastroenterology

London, Greater London, SE5 9RS

Site Contact

Site Contact

patrick.dubois@nhs.net

442032999000

Oxford, Oxfordshire, United Kingdom

Status

Recruiting

Address

John Radcliffe Hospital Dept of Gastroenterology

Oxford, Oxfordshire, OX3 9DU

Sheffield, South Yorkshire, United Kingdom

Status

Recruiting

Address

Royal Hallamshire Hospital Dept of Gastroenterology

Sheffield, South Yorkshire, S10 2JF

Site Contact

Site Contact

david.sanders1@nhs.net

441142261179

Bradford, West Yorkshire, United Kingdom

Status

Recruiting

Address

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, West Yorkshire, BD9 6RJ

Site Contact

Site Contact

pradeep.mundre@bthft.nhs.uk

441274542200

Belfast, United Kingdom

Status

Recruiting

Address

The Ulster Hospital Department of Gastroenterology

Belfast, , BT16 1RH

Site Contact

Site Contact

grant.caddy@setrust.hscni.net

4402890567930

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