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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified July 2025 by Takeda
Sponsor
Takeda
Information Provided by (Responsible Party)
Takeda
Clinicaltrials.gov Identifier
NCT05353985
Other Study ID Numbers:
TAK-062-2001
First Submitted
April 25, 2022
First Posted
April 28, 2022
Results First Posted
July 31, 2025
Last Update Posted
August 19, 2025
Last Verified
July 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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.

Condition or DiseaseIntervention/Treatment
Celiac Disease
Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-BarDrug: TAK-062Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-BarDrug: TAK-062Drug: TAK-062Drug: TAK-062 PlaceboDrug: TAK-062Drug: TAK-062

Study Design

Study TypeInterventional
Actual Enrollment153 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateJune 29, 2022
Actual Primary Completion DateNovember 5, 2024
Actual Study Completion DateNovember 5, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar
SIGE gluten bars.
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.
Drug: TAK-062
TAK-062 tablets.
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.
Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar
SIGE gluten bars.
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.
Drug: TAK-062
TAK-062 tablets.
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.
Drug: TAK-062
TAK-062 tablets.
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.
Drug: TAK-062 Placebo
TAK-062 placebo-matching tablets.
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.
Drug: TAK-062
TAK-062 tablets.
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.
Drug: TAK-062
TAK-062 tablets.

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  1. Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24
    The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. Results are reported as least squares (LS) mean change from baseline at Week 24, determined using an analysis of covariance (ANCOVA) model. A negative change from baseline indicates worsening disease.
  2. Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs
    Adverse event(AE)=any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have causal relationship with this treatment.AE can therefore be any unfavorable\&unintended sign(e.g.,clinically significant abnormal laboratory value, electrocardiogram\[ECG\] value,or vital sign measurement),symptom,or disease temporally associated with use of drug whether or not it is considered related to drug.TEAE=new onset or worsening AEs after first dose of study treatment regardless of relationship to study drug.SAE=any untoward medical occurrence at any dose that results in death,is life threatening,requires inpatient hospitalization/prolongation of existing hospitalization,results in persistent/significant disability/incapacity,leads to a congenital anomaly/birth defect/is important medical event. TEAEs considered related to study drug as assessed by investigator were reported.Percentages were rounded off to nearest single decimal place.
  3. Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062
    A positive ADA participant was defined as a participant who had at least 1 positive ADA result during the study and was further categorized as: Transiently positive- defined as participants with confirmed positive ADA in at least 1 sample and no consecutive samples; Persistently positive- defined as participants with confirmed positive ADA in 2 or more consecutive positive ADA samples.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsTakeda
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35233Research Solutions of Arizona, PC | Litchfield Park Arizona, United States, 85340One of a Kind Clinical Research Center LLC | Paradise Valley Arizona, United States, 85253Mayo Clinic- Arizona | Scottsdale Arizona, United States, 85259GI Alliance- Sun City | Sun City Arizona, United States, 85351Adobe Clinical Research LLC | Tucson Arizona, United States, 85712Gastroenterology and Liver Institute | Escondido California, United States, 92025Om Research LLC | Lancaster California, United States, 93534So. California Research Institute Med Group Inc./West Gastroenterology Med Group | Los Angeles California, United States, 90045UCLA | Los Angeles California, United States, 90404Providence Facey Medical Foundation | Mission Hills California, United States, 91345Stanford University School of Medicine | Redwood City California, United States, 94063Medical Associates Research Group, Inc. | San Diego California, United States, 92123Asthma and Allergy Associates, PC | Colorado Springs Colorado, United States, 80907Medical Research Center of Connecticut, LLC 300143562 | Hamden Connecticut, United States, 06518Central Connecticut Endoscopy Center | Plainville Connecticut, United States, 06062Nature Coast Clinical Research, LLC | Inverness Florida, United States, 34452University of Miami Medical Center | Miami Florida, United States, 33136Wellness Clinical Research | Miami Lakes Florida, United States, 33016Gastroenterology Associates of Pensacola, PA | Pensacola Florida, United States, 32503St. Johns Center for Clinical Research | Saint Augustine Florida, United States, 32086GCP Clinical Research, LLC | Tampa Florida, United States, 33609Agile Clinical Research Trials | Alpharetta Georgia, United States, 30022Lemah Creek Clinical Research | Oakbrook Terrace Illinois, United States, 60181Indiana University -GI | Indianapolis Indiana, United States, 46202University of Iowa Hospital and Clinics | Iowa City Iowa, United States, 52242University Medical Center New Orleans | New Orleans Louisiana, United States, 70112Massachusetts General Hospital | Boston Massachusetts, United States, 02114Beth Israel Deaconess Medical Center | Boston Massachusetts, United States, 02215Lahey Hospital and Medical | Burlington Massachusetts, United States, 01805Hawthorn Medical Associates LLC | South Dartmouth Massachusetts, United States, 02747University of Michigan | Ann Arbor Michigan, United States, 48109Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48047Revive Research Institute, Inc | Farmington Hills Michigan, United States, 48334Mayo Clinic - Rochester | Rochester Minnesota, United States, 55905Washington University, School of Medicine | St Louis Missouri, United States, 63110Manhattan Clinical Research, LLC | Manhattan New York, United States, 10016New York University Medical Center PRIME | New York New York, United States, 10016Blair S Lewis MD | New York New York, United States, 10032Rochester Clinical Research | Rochester New York, United States, 14618Tryon Medical Partners | Charlotte North Carolina, United States, 28210Carolina Digestive Diseases | Greenville North Carolina, United States, 27834Gastro Health Research | Cincinnati Ohio, United States, 45219Cleveland Clinic - Gastroenterology and Hepatology | Cleveland Ohio, United States, 44195Dayton Gastroenterology, Inc | Englewood Ohio, United States, 45415Eastern Pennsylvania Gastroeneterology and Liver Specialists | Allentown Pennsylvania, United States, 18104Thomas Jefferson University | Philadelphia Pennsylvania, United States, 19107Gastroenterology Associates, PA | Greenville South Carolina, United States, 29607Rapid City Medical Center, LLC | Rapid City South Dakota, United States, 57701Vanderbilt University Medical Center | Nashville Tennessee, United States, 37232The Methodist Hospital 150520246 | Houston Texas, United States, 77030Biopharma Informatic, LLC | Houston Texas, United States, 77084Spring Clinical Research | Houston Texas, United States, 77090Biopharma Informatic, LLC | McAllen Texas, United States, 78503Victoria Gastroenterology | Victoria Texas, United States, 77904University of Virginia Medical Center | Charlottesville Virginia, United States, 22903Blue Ridge Medical Research | Lynchburg Virginia, United States, 24502Clinical Research Partners, LLC | Richmond Virginia, United States, 23220Swedish Gastroenterology | Seattle Washington, United States, 98104University of Washington Division of Gastroenterology | Seattle Washington, United States, 98195Velocity Clinical Research | Spokane Washington, United States, 99218AZ Sint-Lucas | Bruges , Belgium, 8310AZ Maria Middelares | Ghent , Belgium, 9000Vitaz | Sint-Niklaas , Belgium, 9100Gastroenterology and Internal Medicine Research Institute (GIRI) | Edmonton Alberta, Canada, T5R 1W2St. Boniface Hospital Inc. Section of Nephrology BG 007 | Winnipeg Manitoba, Canada, R2H 2A6Kensington Screening Clinic | Toronto Ontario, Canada, M5T 3A9McGill University Health Center McGill University | Montreal Quebec, Canada, H3A 1A1Hopital Rangueil Service de Gastro Enterologie et Nutrition | Toulouse Haute Garonne, France, 31059Institut des MICI | Neuilly Hauts De Seine, France, 92200CHU Lille - Hopital Claude Huriez Service des maladies de I'appareil digestif | Lille Nord, France, 59037CHU Saint Etienne - Hopital Nord Service de Gastro-Enterologie et Hepatologie | Saint-Étienne-de-Montluc Pays de la Loire Region, France, 42055Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive | Paris , France, 75015Azienda Ospedaliero Universitaria di Ferrara | Cona Ferrara, Italy, 44124Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milan Milano, Italy, 20122Azienda Ospedaliero Universitaria Ospedali Riuniti- Ospedale Pediatrico UOC Pediatria - G. Salesi | Ancona , Italy, 60123Ospedale Valduce 300205849 | Como , Italy, 22100Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine | Palermo , Italy, 90127Fondazione IRCCS Policlinico San Matteo Sezione di Medicina Interna | Pavia , Italy, 27100Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) U.O. Gastroenterologia | Pisa , Italy, 56124Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia | Roma , Italy, 168Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona | Salerno , Italy, 84131Ospedale Umberto I di Torino S.C. Gastroenterologia | Torino , Italy, 10128FutureMeds Krakow prev. Krakowskie Centrum Medyczne Sp. z o.o. | Krakow , Poland, 31-501ALLMEDICA sp. z o. o. | Nowy Targ , Poland, 34-400Gabinet Lekarski Bartosz Korczowski | Rzeszów , Poland, 35-302Centrum Medyczne Medyk | Rzeszów , Poland, 35-326Warsaw IBD Point Profesor Kierkus | Warsaw , Poland, 00-728Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie | Warsaw , Poland, 02-172Melita Medical SP . Z O. O. | Wroclaw , Poland, 50-449ETG Zamosc | Zamość , Poland, 22-400Vall d'Hebron Research Institute | Barcelona , Spain, 8035Hospital Universitario Ramon y Cajal Servicio de Gastroenterologia | Madrid , Spain, 28034Hospital Clinico Universitario Virgen de la Victoria Digestive Service | Málaga , Spain, 29010Hospital Universitario Virgen Macarena Digestive Service | Seville , Spain, 41009Hospital Universitario Miguel Servet Servicio de Aparato Digestivo | Zaragoza , Spain, 50009Royal London Hospital Dept of Gastroenterology | London Greater London, United Kingdom, E1 1FRKing's College Hospital Dept of Gastroenterology | London Greater London, United Kingdom, SE5 9RSJohn Radcliffe Hospital Dept of Gastroenterology | Oxford Oxfordshire, United Kingdom, OX3 9DURoyal Hallamshire Hospital Dept of Gastroenterology | Sheffield South Yorkshire, United Kingdom, S10 2JFBradford Teaching Hospitals NHS Foundation Trust | Bradford West Yorkshire, United Kingdom, BD9 6RJThe Ulster Hospital Department of Gastroenterology | Belfast , United Kingdom, BT16 1RH
Investigators
Study Director: Medical Director, Takeda
Study Documents (Full Text)
Documents provided by Takeda: Study Protocol  November 15, 2023Documents provided by Takeda: Statistical Analysis Plan  December 2, 2024