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

NCT ID: NCT05353985

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-11-06

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten bars.

TAK-062 Placebo

Intervention Type: DRUG

TAK-062 placebo-matching tablets.

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.

Group Type: EXPERIMENTAL

TAK-062

Intervention Type: DRUG

TAK-062 tablets.

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten bars.

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.

Group Type: PLACEBO_COMPARATOR

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten bars.

TAK-062 Placebo

Intervention Type: DRUG

TAK-062 placebo-matching tablets.

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.

Group Type: EXPERIMENTAL

TAK-062

Intervention Type: DRUG

TAK-062 tablets.

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten bars.

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.

Group Type: EXPERIMENTAL

TAK-062

Intervention Type: DRUG

TAK-062 tablets.

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten bars.

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.

Group Type: PLACEBO_COMPARATOR

TAK-062 Placebo

Intervention Type: DRUG

TAK-062 placebo-matching tablets.

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten-free bars.

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.

Group Type: EXPERIMENTAL

TAK-062

Intervention Type: DRUG

TAK-062 tablets.

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten-free bars.

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.

Group Type: EXPERIMENTAL

TAK-062

Intervention Type: DRUG

TAK-062 tablets.

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

Intervention Type: DIETARY_SUPPLEMENT

SIGE gluten-free bars.

Interventions

TAK-062

TAK-062 tablets.

Intervention Type: DRUG

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

SIGE gluten bars.

Intervention Type: DIETARY_SUPPLEMENT

TAK-062 Placebo

TAK-062 placebo-matching tablets.

Intervention Type: DRUG

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

SIGE gluten-free bars.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Has an adequate comprehension of a gluten-free diet (GFD) assessed by the site investigator after review of responses to a knowledge test. The final determination of a participant's adequate comprehension of a GFD is at the discretion of the investigator.

2. Has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to gluten exposure. The CeD-related symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE).

3. Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant.

4. Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4.

5. The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive.

6. The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.

7. Have a body mass index (BMI) between 16 and 45 kilogram per meter square (kg/m^2), inclusive.

Note: Individuals with BMI of 40 to 45 should be discussed with the medical monitor and confirmed to be appropriate for endoscopy according to local site guidelines.

8. The participant is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the first visit (Visit 1).

There should be no changes to diet, medications (prescription or over-the-counter) or supplements during study participation.

Exclusion Criteria

1. Has the presence of other inflammatory GI disorders or systemic autoimmune diseases that either have the potential to cause persistent GI symptoms similar to CeD or are not well controlled without the use of excluded medication.

• Examples of conditions that are exclusionary include inflammatory bowel disease, eosinophilic esophagitis, gastroenteritis or colitis, microscopic colitis diagnosed at screening or requiring treatment in the 6 months before screening.
• Examples of conditions that may be permissible after discussion with the medical monitor include systemic autoimmune disease such as scleroderma, psoriatic or rheumatoid arthritis, or lupus that is stable and without GI involvement; well controlled autoimmune thyroid disease; well-controlled type 1 diabetes; or proton pump inhibitor (PPI) responsive eosinophilic esophagitis in symptomatic and histologically confirmed remission.

2. Has ongoing systemic immunosuppressant, systemic corticosteroid treatment excluding medication given for the endoscopies, or treatment with systemic immunosuppressants or systemic corticosteroids in the 12 weeks before Screening.

• The participant is receiving immunosuppressive doses of corticosteroids: 3 mg per day or more of budesonide for more than 3 consecutive days within 3 months before Screening, more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 90 days before the first dose, any dose of oral or intravenous (IV) corticosteroids within 30 days of the first dose, or high-dose inhaled corticosteroids (>960 micrograms per day [μg/day] of beclomethasone dipropionate or equivalent), or other systemic immunosuppressive agents.

3. Has ongoing use of over-the-counter digestive enzymes or digestive supplements, other than lactase, including those for gluten digestion. Probiotics are allowable if they were started before Screening and not discontinued or changed in dose or type during the study.

4. Has completed the CDSD on ≤75% of the evaluable days during the run-in period until randomization.

5. Has active microscopic colitis requiring treatment in the 6 months before Screening.

• Microscopic colitis detected at screening if sigmoidoscopy is performed would exclude the participant.

6. Has known or suspected type 2 refractory CeD or ulcerative jejunitis.

7. Has ongoing chronic use (defined as >7 days continuous use) of a nonsteroidal anti-inflammatory drug aside from <100 mg aspirin, daily, for prophylactic use.

8. Has ongoing use, or use in the 3 months before screening, of medications known to cause villous abnormalities (e.g., mycophenolate mofetil, angiotensin receptor blockers, colchicine).

9. Has used treatments for GI symptoms including antiemetics, antidiarrheals, antispasmodics, medical marijuana, (use of medical marijuana indicated for non-GI conditions is not exclusionary) within 2 weeks of Screening and during the run-in period. Participants on stable dose (i.e., more than 4 weeks) of an osmotic, bulking-forming or emollient (surface active agent) laxative are eligible, provided symptoms are considered not related to CeD in the opinion of the investigator.

10. Has a known or suspected severe enteric infection (viral, bacterial, or parasitic) within 6 months before randomization. Severe enteric infection is defined as requiring emergency room visit or hospitalization or treatment with antibiotics or anti-infectives due to infection. Non enteric viral infections, either resolved or well-controlled are not exclusionary.

11. Has a contraindication to endoscopy with duodenal biopsy.

--Contraindication to VCE (strictures, anastomoses, etc) is not an exclusion if the participant is able to complete the other aspects of the study.

12. Has additional food allergies (tapioca syrup, oats, almonds, rice crisp, chocolate, almond, butter, wheat gluten, cocoa butter, oat flour, glycerin, sunflower lecithin, salt, and natural flavors) to nongluten ingredients in the SIGE bar study food or significant symptoms upon ingestion of the gluten-free SIGE bar during screening.

13. Has a history of intolerance, hypersensitivity, or idiosyncratic reaction to an aminoglycoside.

14. Has a known human immunodeficiency virus (HIV) infection or positive tests for hepatitis B or C. The participant has a known clinically significant chronically active hepatopathy of any origin, including cirrhosis, and participants with persistent positive hepatitis B virus surface antigen and quantitative hepatitis B virus polymerase chain reaction (PCR), or positive serology for hepatitis C virus (HCV) and quantitative HCV PCR within 6 months before the screening visit.

15. Is positive for severe acute respiratory syndrome coronavirus 2 at the time of screening and exhibits symptoms that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of study outcomes or safety.

16. Has a known hypersensitivity reaction and/or allergy, including anaphylaxis, to wheat and/or gluten.

17. Has known history of hypersensitivity, idiosyncratic reaction, or intolerance to any ingredients or excipients in TAK-062 and/or placebo.

18. The participant has a current diagnosis of active malignancy or is receiving treatment for active malignancy (hormone therapy alone is not exclusionary). Participants with fully resected Stage 0 (carcinoma in situ) or Stage 1 tumor without signs of recurrence may participate. All other individuals with malignancies diagnosed in the 5 years prior to screening are excluded.

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Research Solutions of Arizona, PC

Litchfield Park, Arizona, United States

One of a Kind Clinical Research Center LLC

Paradise Valley, Arizona, United States

Mayo Clinic- Arizona

Scottsdale, Arizona, United States

GI Alliance- Sun City

Sun City, Arizona, United States

Adobe Clinical Research LLC

Tucson, Arizona, United States

Gastroenterology and Liver Institute

Escondido, California, United States

Om Research LLC

Lancaster, California, United States

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

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

Providence Facey Medical Foundation

Mission Hills, California, United States

Stanford University School of Medicine

Redwood City, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States

Medical Research Center of Connecticut, LLC 300143562

Hamden, Connecticut, United States

Central Connecticut Endoscopy Center

Plainville, Connecticut, United States

Nature Coast Clinical Research, LLC

Inverness, Florida, United States

University of Miami Medical Center

Miami, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, United States

St. Johns Center for Clinical Research

Saint Augustine, Florida, United States

GCP Clinical Research, LLC

Tampa, Florida, United States

Agile Clinical Research Trials

Alpharetta, Georgia, United States

Lemah Creek Clinical Research

Oakbrook Terrace, Illinois, United States

Indiana University -GI

Indianapolis, Indiana, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical

Burlington, Massachusetts, United States

Hawthorn Medical Associates LLC

South Dartmouth, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Revive Research Institute, Inc

Farmington Hills, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University, School of Medicine

St Louis, Missouri, United States

Manhattan Clinical Research, LLC

Manhattan, New York, United States

New York University Medical Center PRIME

New York, New York, United States

Blair S Lewis MD

New York, New York, United States

Rochester Clinical Research

Rochester, New York, United States

Tryon Medical Partners

Charlotte, North Carolina, United States

Carolina Digestive Diseases

Greenville, North Carolina, United States

Gastro Health Research

Cincinnati, Ohio, United States

Cleveland Clinic - Gastroenterology and Hepatology

Cleveland, Ohio, United States

Dayton Gastroenterology, Inc

Englewood, Ohio, United States

Eastern Pennsylvania Gastroeneterology and Liver Specialists

Allentown, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Gastroenterology Associates, PA

Greenville, South Carolina, United States

Rapid City Medical Center, LLC

Rapid City, South Dakota, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The Methodist Hospital 150520246

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Spring Clinical Research

Houston, Texas, United States

Biopharma Informatic, LLC

McAllen, Texas, United States

Victoria Gastroenterology

Victoria, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Swedish Gastroenterology

Seattle, Washington, United States

University of Washington Division of Gastroenterology

Seattle, Washington, United States

Velocity Clinical Research

Spokane, Washington, United States

AZ Sint-Lucas

Bruges, , Belgium

AZ Maria Middelares

Ghent, , Belgium

Vitaz

Sint-Niklaas, , Belgium

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta, Canada

St. Boniface Hospital Inc. Section of Nephrology BG 007

Winnipeg, Manitoba, Canada

Kensington Screening Clinic

Toronto, Ontario, Canada

McGill University Health Center McGill University

Montreal, Quebec, Canada

Hopital Rangueil Service de Gastro Enterologie et Nutrition

Toulouse, Haute Garonne, France

Institut des MICI

Neuilly, Hauts De Seine, France

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

Lille, Nord, France

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

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

Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive

Paris, , France

Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Milano, Italy

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

Ancona, , Italy

Ospedale Valduce 300205849

Como, , Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine

Palermo, , Italy

Fondazione IRCCS Policlinico San Matteo Sezione di Medicina Interna

Pavia, , Italy

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

Pisa, , Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia

Roma, , Italy

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

Salerno, , Italy

Ospedale Umberto I di Torino S.C. Gastroenterologia

Torino, , Italy

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

Krakow, , Poland

ALLMEDICA sp. z o. o.

Nowy Targ, , Poland

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie

Warsaw, , Poland

Melita Medical SP . Z O. O.

Wroclaw, , Poland

ETG Zamosc

Zamość, , Poland

Vall d'Hebron Research Institute

Barcelona, , Spain

Hospital Universitario Ramon y Cajal Servicio de Gastroenterologia

Madrid, , Spain

Hospital Clinico Universitario Virgen de la Victoria Digestive Service

Málaga, , Spain

Hospital Universitario Virgen Macarena Digestive Service

Seville, , Spain

Hospital Universitario Miguel Servet Servicio de Aparato Digestivo

Zaragoza, , Spain

Royal London Hospital Dept of Gastroenterology

London, Greater London, United Kingdom

King's College Hospital Dept of Gastroenterology

London, Greater London, United Kingdom

John Radcliffe Hospital Dept of Gastroenterology

Oxford, Oxfordshire, United Kingdom

Royal Hallamshire Hospital Dept of Gastroenterology

Sheffield, South Yorkshire, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, West Yorkshire, United Kingdom

The Ulster Hospital Department of Gastroenterology

Belfast, , United Kingdom

Countries

United States; Belgium; Canada; France; Italy; Poland; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/44e4ec7deb684f49?idFilter=%5B%22TAK-062-2001%22%5D

To obtain more information on the study, click on this link

Other Identifiers

2020-005438-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TAK-062-2001

Identifier Type: -

Identifier Source: org_study_id