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 |
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 (including but not limited to the following: inflammatory bowel disease, eosinophilic esophagitis, gastroenteritis or colitis, microscopic colitis diagnosed at screening or requiring treatment in the 6 months before screening, scleroderma, psoriatic or rheumatoid arthritis, lupus) other than those noted below:- - Thyroid disease that has been well-controlled for at least 6 months.
- - Well-controlled type 1 diabetes (glycosylated hemoglobin <8% and no hospitalization or emergency room visit in the last 12 months for hyperglycemia or hypoglycemia).
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 |
Study Website: | View Trial Website |
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 377 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 and Gluten-free SIGE Bar. 2. Cohort 1 (Age 18 and older): TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE Bar. After the interim analysis, 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 and Gluten-free SIGE Bar. 2. Cohort 2 (Age 18 and older): TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE Bar. 3. Cohort 2 (Age 18 and older): TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE 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
Placebo Comparator: Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE 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. Participants also receive gluten-free bar during the run-in period.
Experimental: Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE 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. Participants also receive gluten-free bar during the run-in period.
Placebo Comparator: Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar
TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Experimental: Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE Bar
TAK-062 Dose 2, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Experimental: Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE Bar
TAK-062 Dose 3, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten and gluten free 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.
Status
Recruiting
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University of Alabama at Birmingham
Birmingham, Alabama, 35233
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Recruiting
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Research Solutions of Arizona, PC
Litchfield Park, Arizona, 85340
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One of a Kind Clinical Research Center LLC
Paradise Valley, Arizona, 85253
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Mayo Clinic- Arizona
Scottsdale, Arizona, 85259
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GI Alliance- Sun City
Sun City, Arizona, 85351
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Adobe Clinical Research LLC
Tucson, Arizona, 85712
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Gastroenterology and Liver Institute
Escondido, California, 92025
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Om Research LLC
Lancaster, California, 93534
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Om Research LLC
Lancaster, California, 93534
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Recruiting
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Om Research LLC
Lancaster, California, 93534
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Recruiting
Address
So. California Research Institute Med Group Inc./West Gastroenterology Med Group
Los Angeles, California, 90045
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Address
Providence Facey Medical Foundation
Mission Hills, California, 91345
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Recruiting
Address
Stanford University School of Medicine
Redwood City, California, 94063
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Recruiting
Address
Medical Associates Research Group, Inc.
San Diego, California, 92123
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Recruiting
Address
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
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Recruiting
Address
Central Connecticut Endoscopy Center
Plainville, Connecticut, 06062
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Recruiting
Address
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452
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Recruiting
Address
Wellness Clinical Research
Miami Lakes, Florida, 33016
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Recruiting
Address
University of Miami Medical Center
Miami, Florida, 33136
Status
Recruiting
Address
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503
Status
Recruiting
Address
St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086
Status
Recruiting
Address
GCP Clinical Research, LLC
Tampa, Florida, 33609
Status
Recruiting
Address
Agile Clinical Research Trials
Alpharetta, Georgia, 30022
Status
Recruiting
Address
Lemah Creek Clinical Research
Oakbrook Terrace, Illinois, 60181
Status
Recruiting
Address
Indiana University -GI
Indianapolis, Indiana, 46202
Status
Recruiting
Address
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Status
Recruiting
Address
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Status
Recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Recruiting
Address
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Status
Recruiting
Address
Hawthorn Medical Associates LLC
South Dartmouth, Massachusetts, 02747
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Status
Recruiting
Address
Revive Research Institute, Inc
Farmington Hills, Michigan, 48334
Status
Recruiting
Address
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Status
Recruiting
Address
Washington University, School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Manhattan Clinical Research, LLC
Manhattan, New York, 10016
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Recruiting
Address
New York University Medical Center PRIME
New York, New York, 10016
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Recruiting
Address
Blair S Lewis MD
New York, New York, 10032
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Recruiting
Address
Rochester Clinical Research
Rochester, New York, 14618
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Recruiting
Address
Tryon Medical Partners
Charlotte, North Carolina, 28210
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Recruiting
Address
Carolina Digestive Diseases
Greenville, North Carolina, 27834
Status
Recruiting
Address
Gastro Health Research
Cincinnati, Ohio, 45219
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Recruiting
Address
Cleveland Clinic - Gastroenterology and Hepatology
Cleveland, Ohio, 44195
Status
Recruiting
Address
Dayton Gastroenterology, Inc
Englewood, Ohio, 45415
Status
Recruiting
Address
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Status
Recruiting
Address
Gastroenterology Associates, PA
Greenville, South Carolina, 29607
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Recruiting
Address
Rapid City Medical Center, LLC
Rapid City, South Dakota, 57701
Status
Recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
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Recruiting
Address
Biopharma Informatic, LLC
Houston, Texas, 77084
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Recruiting
Address
Biopharma Informatic, LLC
McAllen, Texas, 78503
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Recruiting
Address
Victoria Gastroenterology
Victoria, Texas, 77904
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Recruiting
Address
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
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Recruiting
Address
Clinical Research Partners, LLC
Richmond, Virginia, 23220
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Recruiting
Address
Swedish Gastroenterology
Seattle, Washington, 98104
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Recruiting
Address
Velocity Clinical Research
Spokane, Washington, 99204
International Sites
Status
Recruiting
Address
AZ Sint-Lucas
Brugge, , 8310
Status
Recruiting
Address
AZ Maria Middelares
Gent, , 9000
Status
Recruiting
Address
Vitaz
Sint-Niklaas, , 9100
Status
Recruiting
Address
Kensington Clinic
Toronto, Ontario, M5T 3A9
Status
Recruiting
Address
Hopital Rangueil Service de Gastro Enterologie et Nutrition
Toulouse Cedex 09, Haute Garonne, 31059
Status
Recruiting
Address
CHU Saint Etienne - Hopital Nord Service de Gastro-Enterologie et Hepatologie
Saint Etienne, Loire, 42055
Status
Recruiting
Address
CHU Lille - Hopital Claude Huriez Service des maladies de I'appareil digestif
Lille cedex, Nord, 59037
Status
Recruiting
Address
Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive
Paris, , 75015
Status
Recruiting
Address
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano, , 20122
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine
Palermo, , 90127
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) U.O. Gastroenterologia
Pisa, , 56124
Status
Recruiting
Address
Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia
Roma, , 168
Status
Recruiting
Address
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, , 84131
Status
Recruiting
Address
Ospedale Umberto I di Torino S.C. Gastroenterologia
Torino, , 10128
Status
Recruiting
Address
FutureMeds Krakow prev. Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , 31-501
Status
Recruiting
Address
ALLMEDICA sp. z o. o.
Nowy Targ, , 34-400
Status
Recruiting
Address
Gabinet Lekarski Bartosz Korczowski
Rzeszow, , 35-302
Status
Recruiting
Address
Centrum Medyczne Medyk
Rzeszow, , 35-326
Status
Recruiting
Address
Warsaw IBD Point Profesor Kierkus
Warszawa, , 00-728
Status
Recruiting
Address
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie
Warszawa, , 02-172
Status
Recruiting
Address
Melita Medical SP . Z O. O.
Wroclaw, , 50-449
Status
Recruiting
Address
ETG Zamosc
Zamosc, , 22-400
Status
Recruiting
Address
Vall d'Hebron Research Institute
Barcelona, , 8035
Status
Recruiting
Address
Hospital Clinico Universitario Virgen de la Victoria Digestive Service
Malaga, , 29010
Status
Recruiting
Address
Hospital Universitario Virgen Macarena Digestive Service
Sevilla, , 41009
Status
Recruiting
Address
Hospital Universitario Miguel Servet Servicio de Aparato Digestivo
Zaragoza, , 50009
Status
Recruiting
Address
Royal London Hospital Dept of Gastroenterology
London, Greater London, E1 1FR
Status
Recruiting
Address
King's College Hospital Dept of Gastroenterology
London, Greater London, SE5 9RS
Status
Recruiting
Address
John Radcliffe Hospital Dept of Gastroenterology
Oxford, Oxfordshire, OX3 9DU
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Recruiting
Address
Royal Hallamshire Hospital Dept of Gastroenterology
Sheffield, South Yorkshire, S10 2JF
Status
Recruiting
Address
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, BD9 6RJ
Status
Recruiting
Address
The Ulster Hospital Department of Gastroenterology
Belfast, , BT16 1RH