A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet
2 other identifiers
interventional
153
8 countries
102
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2022
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2024
CompletedResults Posted
Study results publicly available
August 20, 2025
CompletedAugust 20, 2025
August 1, 2025
2.4 years
April 26, 2022
August 1, 2025
August 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12
CDSD GI symptom severity score is an average of the daily GI symptom severity scores during the week. The daily GI symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating and nausea, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as least squares (LS) mean change from baseline at Week 12, determined using a mixed-effect model for repeated measures (MMRM). A negative change from baseline indicates improvement.
Baseline (Week -1) to Week 12
Secondary Outcomes (3)
Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24
Baseline (Week -4, Run-in Period) to Week 24
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs
Up to Week 28
Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062
Up to Week 28
Study Arms (8)
Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar
PLACEBO COMPARATORTAK-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.
Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar
EXPERIMENTALTAK-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.
Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar
PLACEBO COMPARATORTAK-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.
Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar
EXPERIMENTALTAK-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.
Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar
EXPERIMENTALTAK-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.
Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar
PLACEBO COMPARATORTAK-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.
Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar
EXPERIMENTALTAK-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.
Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE Bar
EXPERIMENTALTAK-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
TAK-062 tablets.
SIGE gluten bars.
TAK-062 placebo-matching tablets.
SIGE gluten-free bars.
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant.
- Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd \<2.5 at Week -4.
- The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive.
- The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.
- 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.
- 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.
You may not qualify if:
- 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 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.
- 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.
- 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.
- Has completed the CDSD on ≤75% of the evaluable days during the run-in period until randomization.
- 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.
- Has known or suspected type 2 refractory CeD or ulcerative jejunitis.
- 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.
- 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).
- Has a contraindication to endoscopy with duodenal biopsy.
- 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.
- Has a history of intolerance, hypersensitivity, or idiosyncratic reaction to an aminoglycoside.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (102)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Research Solutions of Arizona, PC
Litchfield Park, Arizona, 85340, United States
One of a Kind Clinical Research Center LLC
Paradise Valley, Arizona, 85253, United States
Mayo Clinic- Arizona
Scottsdale, Arizona, 85259, United States
GI Alliance- Sun City
Sun City, Arizona, 85351, United States
Adobe Clinical Research LLC
Tucson, Arizona, 85712, United States
Gastroenterology and Liver Institute
Escondido, California, 92025, United States
Om Research LLC
Lancaster, California, 93534, United States
So. California Research Institute Med Group Inc./West Gastroenterology Med Group
Los Angeles, California, 90045, United States
UCLA
Los Angeles, California, 90404, United States
Providence Facey Medical Foundation
Mission Hills, California, 91345, United States
Stanford University School of Medicine
Redwood City, California, 94063, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
Medical Research Center of Connecticut, LLC 300143562
Hamden, Connecticut, 06518, United States
Central Connecticut Endoscopy Center
Plainville, Connecticut, 06062, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452, United States
University of Miami Medical Center
Miami, Florida, 33136, United States
Wellness Clinical Research
Miami Lakes, Florida, 33016, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503, United States
St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086, United States
GCP Clinical Research, LLC
Tampa, Florida, 33609, United States
Agile Clinical Research Trials
Alpharetta, Georgia, 30022, United States
Lemah Creek Clinical Research
Oakbrook Terrace, Illinois, 60181, United States
Indiana University -GI
Indianapolis, Indiana, 46202, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital and Medical
Burlington, Massachusetts, 01805, United States
Hawthorn Medical Associates LLC
South Dartmouth, Massachusetts, 02747, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Revive Research Institute, Inc
Farmington Hills, Michigan, 48334, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Washington University, School of Medicine
St Louis, Missouri, 63110, United States
Manhattan Clinical Research, LLC
Manhattan, New York, 10016, United States
New York University Medical Center PRIME
New York, New York, 10016, United States
Blair S Lewis MD
New York, New York, 10032, United States
Rochester Clinical Research
Rochester, New York, 14618, United States
Tryon Medical Partners
Charlotte, North Carolina, 28210, United States
Carolina Digestive Diseases
Greenville, North Carolina, 27834, United States
Gastro Health Research
Cincinnati, Ohio, 45219, United States
Cleveland Clinic - Gastroenterology and Hepatology
Cleveland, Ohio, 44195, United States
Dayton Gastroenterology, Inc
Englewood, Ohio, 45415, United States
Eastern Pennsylvania Gastroeneterology and Liver Specialists
Allentown, Pennsylvania, 18104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29607, United States
Rapid City Medical Center, LLC
Rapid City, South Dakota, 57701, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The Methodist Hospital 150520246
Houston, Texas, 77030, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Spring Clinical Research
Houston, Texas, 77090, United States
Biopharma Informatic, LLC
McAllen, Texas, 78503, United States
Victoria Gastroenterology
Victoria, Texas, 77904, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23220, United States
Swedish Gastroenterology
Seattle, Washington, 98104, United States
University of Washington Division of Gastroenterology
Seattle, Washington, 98195, United States
Velocity Clinical Research
Spokane, Washington, 99218, United States
AZ Sint-Lucas
Bruges, 8310, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Vitaz
Sint-Niklaas, 9100, Belgium
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2, Canada
St. Boniface Hospital Inc. Section of Nephrology BG 007
Winnipeg, Manitoba, R2H 2A6, Canada
Kensington Screening Clinic
Toronto, Ontario, M5T 3A9, Canada
McGill University Health Center McGill University
Montreal, Quebec, H3A 1A1, Canada
Hopital Rangueil Service de Gastro Enterologie et Nutrition
Toulouse, Haute Garonne, 31059, France
Institut des MICI
Neuilly, Hauts De Seine, 92200, France
CHU Lille - Hopital Claude Huriez Service des maladies de I'appareil digestif
Lille, Nord, 59037, France
CHU Saint Etienne - Hopital Nord Service de Gastro-Enterologie et Hepatologie
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive
Paris, 75015, France
Azienda Ospedaliero Universitaria di Ferrara
Cona, Ferrara, 44124, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Milano, 20122, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti- Ospedale Pediatrico UOC Pediatria - G. Salesi
Ancona, 60123, Italy
Ospedale Valduce 300205849
Como, 22100, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine
Palermo, 90127, Italy
Fondazione IRCCS Policlinico San Matteo Sezione di Medicina Interna
Pavia, 27100, Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) U.O. Gastroenterologia
Pisa, 56124, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia
Roma, 168, Italy
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131, Italy
Ospedale Umberto I di Torino S.C. Gastroenterologia
Torino, 10128, Italy
FutureMeds Krakow prev. Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501, Poland
ALLMEDICA sp. z o. o.
Nowy Targ, 34-400, Poland
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie
Warsaw, 02-172, Poland
Melita Medical SP . Z O. O.
Wroclaw, 50-449, Poland
ETG Zamosc
Zamość, 22-400, Poland
Vall d'Hebron Research Institute
Barcelona, 8035, Spain
Hospital Universitario Ramon y Cajal Servicio de Gastroenterologia
Madrid, 28034, Spain
Hospital Clinico Universitario Virgen de la Victoria Digestive Service
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena Digestive Service
Seville, 41009, Spain
Hospital Universitario Miguel Servet Servicio de Aparato Digestivo
Zaragoza, 50009, Spain
Royal London Hospital Dept of Gastroenterology
London, Greater London, E1 1FR, United Kingdom
King's College Hospital Dept of Gastroenterology
London, Greater London, SE5 9RS, United Kingdom
John Radcliffe Hospital Dept of Gastroenterology
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Royal Hallamshire Hospital Dept of Gastroenterology
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
The Ulster Hospital Department of Gastroenterology
Belfast, BT16 1RH, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2022
First Posted
April 29, 2022
Study Start
June 30, 2022
Primary Completion
November 6, 2024
Study Completion
November 6, 2024
Last Updated
August 20, 2025
Results First Posted
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.