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AzTrials

Celiac DiseasePhase 2NCT05353985

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

A Phase 2 study testing TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar and Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar in people with Celiac Disease, run by Takeda at 102 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Celiac Disease
What is being tested?
TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar and Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
102 sitesin 8 countries
Study dates
30 Jun 2022to 6 Nov 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
  • 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.
Show all 26Show fewer
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Has a known hypersensitivity reaction and/or allergy, including anaphylaxis, to wheat and/or gluten.
  • Has known history of hypersensitivity, idiosyncratic reaction, or intolerance to any ingredients or excipients in TAK-062 and/or placebo.
  • 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 locations and contacts

102 sites in 8 countries.

102 sites in 8 countries

United States61 sites

  • Eastern Pennsylvania Gastroeneterology and Liver Specialists

    Allentown, Pennsylvania, 18104

  • Agile Clinical Research Trials

    Alpharetta, Georgia, 30022

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Lahey Hospital and Medical

    Burlington, Massachusetts, 01805

  • Tryon Medical Partners

    Charlotte, North Carolina, 28210

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Gastro Health Research

    Cincinnati, Ohio, 45219

  • Cleveland Clinic - Gastroenterology and Hepatology

    Cleveland, Ohio, 44195

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado, 80907

  • Dayton Gastroenterology, Inc

    Englewood, Ohio, 45415

  • Gastroenterology and Liver Institute

    Escondido, California, 92025

  • Revive Research Institute, Inc

    Farmington Hills, Michigan, 48334

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Gastroenterology Associates, PA

    Greenville, South Carolina, 29607

  • Medical Research Center of Connecticut, LLC 300143562

    Hamden, Connecticut, 06518

  • The Methodist Hospital 150520246

    Houston, Texas, 77030

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Spring Clinical Research

    Houston, Texas, 77090

  • Indiana University -GI

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Om Research LLC

    Lancaster, California, 93534

  • Research Solutions of Arizona, PC

    Litchfield Park, Arizona, 85340

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

    Los Angeles, California, 90045

  • UCLA

    Los Angeles, California, 90404

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Manhattan Clinical Research, LLC

    Manhattan, New York, 10016

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503

  • University of Miami Medical Center

    Miami, Florida, 33136

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Blair S Lewis MD

    New York, New York, 10032

  • Lemah Creek Clinical Research

    Oakbrook Terrace, Illinois, 60181

  • One of a Kind Clinical Research Center LLC

    Paradise Valley, Arizona, 85253

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Central Connecticut Endoscopy Center

    Plainville, Connecticut, 06062

  • Rapid City Medical Center, LLC

    Rapid City, South Dakota, 57701

  • Stanford University School of Medicine

    Redwood City, California, 94063

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23220

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Rochester Clinical Research

    Rochester, New York, 14618

  • St. Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Mayo Clinic- Arizona

    Scottsdale, Arizona, 85259

  • Swedish Gastroenterology

    Seattle, Washington, 98104

  • University of Washington Division of Gastroenterology

    Seattle, Washington, 98195

  • Hawthorn Medical Associates LLC

    South Dartmouth, Massachusetts, 02747

  • Velocity Clinical Research

    Spokane, Washington, 99218

  • Washington University, School of Medicine

    St Louis, Missouri, 63110

  • GI Alliance- Sun City

    Sun City, Arizona, 85351

  • GCP Clinical Research, LLC

    Tampa, Florida, 33609

  • Adobe Clinical Research LLC

    Tucson, Arizona, 85712

  • Victoria Gastroenterology

    Victoria, Texas, 77904

Other trials in United States

Italy10 sites

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

    Ancona, 60123

  • Ospedale Valduce 300205849

    Como, 22100

  • Azienda Ospedaliero Universitaria di Ferrara

    Cona, Ferrara, 44124

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, Milano, 20122

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine

    Palermo, 90127

  • Fondazione IRCCS Policlinico San Matteo Sezione di Medicina Interna

    Pavia, 27100

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

    Pisa, 56124

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia

    Roma, 168

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

    Salerno, 84131

  • Ospedale Umberto I di Torino S.C. Gastroenterologia

    Torino, 10128

Other trials in Italy

Poland8 sites

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

    Krakow, 31-501

  • ALLMEDICA sp. z o. o.

    Nowy Targ, 34-400

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, 35-302

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie

    Warsaw, 02-172

  • Melita Medical SP . Z O. O.

    Wroclaw, 50-449

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

United Kingdom6 sites

  • The Ulster Hospital Department of Gastroenterology

    Belfast, BT16 1RH

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, West Yorkshire, BD9 6RJ

  • Royal London Hospital Dept of Gastroenterology

    London, Greater London, E1 1FR

  • King's College Hospital Dept of Gastroenterology

    London, Greater London, SE5 9RS

  • John Radcliffe Hospital Dept of Gastroenterology

    Oxford, Oxfordshire, OX3 9DU

  • Royal Hallamshire Hospital Dept of Gastroenterology

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

France5 sites

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

    Lille, Nord, 59037

  • Institut des MICI

    Neuilly, Hauts De Seine, 92200

  • Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive

    Paris, 75015

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

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055

  • Hopital Rangueil Service de Gastro Enterologie et Nutrition

    Toulouse, Haute Garonne, 31059

Other trials in France

Spain5 sites

  • Vall d'Hebron Research Institute

    Barcelona, 8035

  • Hospital Universitario Ramon y Cajal Servicio de Gastroenterologia

    Madrid, 28034

  • Hospital Clinico Universitario Virgen de la Victoria Digestive Service

    Málaga, 29010

  • Hospital Universitario Virgen Macarena Digestive Service

    Seville, 41009

  • Hospital Universitario Miguel Servet Servicio de Aparato Digestivo

    Zaragoza, 50009

Other trials in Spain

Canada4 sites

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

  • McGill University Health Center McGill University

    Montreal, Quebec, H3A 1A1

  • Kensington Screening Clinic

    Toronto, Ontario, M5T 3A9

  • St. Boniface Hospital Inc. Section of Nephrology BG 007

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Belgium3 sites

  • AZ Sint-Lucas

    Bruges, 8310

  • AZ Maria Middelares

    Ghent, 9000

  • Vitaz

    Sint-Niklaas, 9100

Other trials in Belgium

About this study

Official title: 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

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.

Read the detailed 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.

Conditions
Celiac Disease
Being tested
TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 Placebo, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
Keywords
Drug Therapy
Medical subject headings
Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-062Drug

    TAK-062 tablets.

  • Simulated Inadvertent Gluten Exposure (SIGE) Gluten-BarDietary supplement

    SIGE gluten bars.

  • TAK-062 PlaceboDrug

    TAK-062 placebo-matching tablets.

  • Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free BarDietary supplement

    SIGE gluten-free bars.

Study groups in NCT05353985
Study groupRoleWhat they receive
Cohort 1: TAK-062 Placebo + SIGE Gluten-BarPlacebo 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.
Receives: Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; Drug: TAK-062 Placebo
Cohort 1: TAK-062 Dose 1 + SIGE Gluten-BarExperimentalTAK-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.
Receives: Drug: TAK-062; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar
Cohort 2: TAK-062 Placebo + SIGE Gluten-BarPlacebo 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.
Receives: Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; Drug: TAK-062 Placebo
Cohort 2: TAK-062 Dose 2 + SIGE Gluten-BarExperimentalTAK-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.
Receives: Drug: TAK-062; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar
Cohort 2: TAK-062 Dose 3 + SIGE Gluten-BarExperimentalTAK-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.
Receives: Drug: TAK-062; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar
Cohort 2: TAK-062 Placebo + Gluten-free SIGE BarPlacebo 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.
Receives: Drug: TAK-062 Placebo; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE BarExperimentalTAK-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.
Receives: Drug: TAK-062; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE BarExperimentalTAK-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.
Receives: Drug: TAK-062; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week -1) to Week 12

Secondary outcomes (3)

  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.

    Measured: Baseline (Week -4, Run-in Period) to Week 24

  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.

    Measured: Up to Week 28

  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.

    Measured: Up to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start30 Jun 2022
  3. Primary completion6 Nov 2024
  4. Study completion6 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05353985
Sponsor's protocol ID
TAK-062-2001
Other IDs
2020-005438-14
Status last verified
Aug 2025
First submitted
26 Apr 2022
Last updated
20 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar and Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar in people with Celiac Disease, run by Takeda at 102 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Italy, Poland, United Kingdom, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12 (time frame: Baseline (Week -1) to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05353985.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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