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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Celiac Disease
• Intervention / Treatment: Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; Drug: TAK-062 Placebo; Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar; Drug: TAK-062

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.

• Study Type: Interventional
• Enrollment (Estimated): 357
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Belgium
  • Brugge, Belgium, 8310
    • AZ Sint-Lucas
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Sint-Niklaas, Belgium, 9100
    • VITAZ
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5R 1W2
      • Gastroenterology and Internal Medicine Research Institute (GIRI)
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital Inc. Section of Nephrology BG 007
  • Ontario
    • Toronto, Ontario, Canada, M5T 3A9
      • Kensington Screening Clinic
• France
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive
  • Haute Garonne
    • Toulouse Cedex 09, Haute Garonne, France, 31059
      • Hopital Rangueil Service de Gastro Enterologie et Nutrition
  • Hauts De Seine
    • Neuilly, Hauts De Seine, France, 92200
      • Institut des MICI
  • Loire
    • Saint Etienne, Loire, France, 42055
      • CHU Saint Etienne - Hopital Nord Service de Gastro-Enterologie et Hepatologie
  • Nord
    • Lille cedex, Nord, France, 59037
      • CHU Lille - Hopital Claude Huriez Service des maladies de I'appareil digestif
• Italy
  • Ancona, Italy, 60123
    • Azienda Ospedaliero Universitaria Ospedali Riuniti- Ospedale Pediatrico UOC Pediatria - G. Salesi
  • Como, Italy, 22100
    • Ospedale Valduce 300205849
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo Sezione di Medicina Interna
  • Pisa, Italy, 56124
    • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) U.O. Gastroenterologia
  • Roma, Italy, 168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia
  • Salerno, Italy, 84131
    • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
  • Torino, Italy, 10128
    • Ospedale Umberto I di Torino S.C. Gastroenterologia
  • Milano
    • Milan, Milano, Italy, 20122
      • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
• Poland
  • Krakow, Poland, 31-501
    • FutureMeds Krakow prev. Krakowskie Centrum Medyczne Sp. z o.o.
  • Nowy Targ, Poland, 34-400
    • ALLMEDICA sp. z o. o.
  • Rzeszow, Poland, 35-302
    • Gabinet Lekarski Bartosz Korczowski
  • Rzeszow, Poland, 35-326
    • Centrum Medyczne Medyk
  • Warszawa, Poland, 00-728
    • Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 02-172
    • Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie
  • Wroclaw, Poland, 50-449
    • Melita Medical SP . Z O. O.
  • Zamosc, Poland, 22-400
    • ETG Zamosc
• Spain
  • Barcelona, Spain, 8035
    • Vall d'Hebron Research Institute
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal Servicio de Gastroenterologia
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria Digestive Service
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena Digestive Service
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet Servicio de Aparato Digestivo
• United Kingdom
  • Belfast, United Kingdom, BT16 1RH
    • The Ulster Hospital Department of Gastroenterology
  • Greater London
    • London, Greater London, United Kingdom, E1 1FR
      • Royal London Hospital Dept of Gastroenterology
    • London, Greater London, United Kingdom, SE5 9RS
      • King's College Hospital Dept of Gastroenterology
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • John Radcliffe Hospital Dept of Gastroenterology
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Royal Hallamshire Hospital Dept of Gastroenterology
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Bradford Teaching Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Research Solutions of Arizona, PC
    • Paradise Valley, Arizona, United States, 85253
      • One of a Kind Clinical Research Center LLC
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic- Arizona
    • Sun City, Arizona, United States, 85351
      • GI Alliance- Sun City
    • Tucson, Arizona, United States, 85712
      • Adobe Clinical Research LLC
  • California
    • Escondido, California, United States, 92025
      • Gastroenterology and Liver Institute
    • Lancaster, California, United States, 93534
      • OM Research LLC
    • Los Angeles, California, United States, 90404
      • UCLA
    • Los Angeles, California, United States, 90045
      • So. California Research Institute Med Group Inc./West Gastroenterology Med Group
    • Mission Hills, California, United States, 91345
      • Providence Facey Medical Foundation
    • Redwood City, California, United States, 94063
      • Stanford University School of Medicine
    • San Diego, California, United States, 92123
      • Medical Associates Research Group, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates, PC
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut, LLC 300143562
    • Plainville, Connecticut, United States, 06062
      • Central Connecticut Endoscopy Center
  • Florida
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research, LLC
    • Miami, Florida, United States, 33136
      • University of Miami Medical Center
    • Miami Lakes, Florida, United States, 33016
      • Wellness Clinical Research
    • Pensacola, Florida, United States, 32503
      • Gastroenterology Associates of Pensacola, PA
    • Saint Augustine, Florida, United States, 32086
      • St. Johns Center for Clinical Research
    • Tampa, Florida, United States, 33609
      • GCP Clinical Research, LLC
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Agile Clinical Research Trials
  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60181
      • Lemah Creek Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University -GI
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical
    • South Dartmouth, Massachusetts, United States, 02747
      • Hawthorn Medical Associates LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Farmington Hills, Michigan, United States, 48334
      • Revive Research Institute, Inc
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University, School of Medicine
  • New York
    • Manhattan, New York, United States, 10016
      • Manhattan Clinical Research, LLC
    • New York, New York, United States, 10016
      • New York University Medical Center PRIME
    • New York, New York, United States, 10032
      • Blair S Lewis MD
    • Rochester, New York, United States, 14618
      • Rochester Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Tryon Medical Partners
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Gastro Health Research
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic - Gastroenterology and Hepatology
    • Englewood, Ohio, United States, 45415
      • Dayton Gastroenterology, Inc
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Eastern Pennsylvania Gastroeneterology and Liver Specialists
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Gastroenterology Associates, PA
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Medical Center, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, Llc
    • Houston, Texas, United States, 77030
      • The Methodist Hospital 150520246
    • Houston, Texas, United States, 77090
      • Spring Clinical Research
    • McAllen, Texas, United States, 78503
      • Biopharma Informatic, Llc
    • Victoria, Texas, United States, 77904
      • Victoria Gastroenterology
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Medical Center
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
    • Richmond, Virginia, United States, 23220
      • Clinical Research Partners, LLC
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Gastroenterology
    • Seattle, Washington, United States, 98195
      • University of Washington Division of Gastroenterology
    • Spokane, Washington, United States, 99218
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar; TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.	Drug: TAK-062 Placebo; TAK-062 placebo-matching tablets.; Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar; SIGE gluten-free bars.
Experimental: Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar; TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.	Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar; SIGE gluten-free bars.; Drug: TAK-062; TAK-062 tablets.
Experimental: Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE Bar; TAK-062 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.	Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar; SIGE gluten-free bars.; Drug: TAK-062; TAK-062 tablets.
Placebo Comparator: 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.; Drug: TAK-062 Placebo; TAK-062 placebo-matching tablets.
Experimental: 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.	Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; SIGE gluten bars.; Drug: TAK-062; TAK-062 tablets.
Placebo Comparator: 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.; Drug: TAK-062 Placebo; TAK-062 placebo-matching tablets.
Experimental: 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.	Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; SIGE gluten bars.; Drug: TAK-062; TAK-062 tablets.
Experimental: 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.	Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; SIGE gluten bars.; Drug: TAK-062; TAK-062 tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 severe symptoms.	Baseline (Week -1) to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week -4, Run-in Period) to Week 24
Percentage of Participants with Positive Antidrug Antibodies (ADA) in Serum for TAK-062	A positive ADA participant is defined as a participant who has at least 1 positive ADA result during the study and is 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.	Up to Week 28
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Adverse Events (SAEs) and Treatment-Related TEAEs	Adverse event (AE)= any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (e.g., clinically significant abnormal laboratory value, electrocardiogram[ECG] value, or vital sign measurement), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. TEAE=new onset or worsening AEs after the 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 or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is an important medical event. TEAEs considered related to the study drug as assessed by the Investigator will be reported.	Up to Week 28

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Estimated): May 6, 2025
• Study Completion (Estimated): May 6, 2025

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: TAK-062-2001; 2020-005438-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No