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

• ClinicalTrials.gov Identifier: NCT05353985
• Recruitment Status: Active, not recruiting
• First Posted: April 29, 2022
• Last Update Posted: March 13, 2024
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Celiac Disease	Drug: TAK-062; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; Drug: TAK-062 Placebo; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 357 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 30, 2022
• Estimated Primary Completion Date: May 6, 2025
• Estimated Study Completion Date: May 6, 2025

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: TAK-062; TAK-062 tablets.; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; SIGE gluten bars.
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.	Drug: TAK-062; TAK-062 tablets.; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; SIGE gluten bars.
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.	Drug: TAK-062; TAK-062 tablets.; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar; SIGE gluten bars.
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.	Drug: TAK-062; TAK-062 tablets.; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar; SIGE gluten-free bars.
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.	Drug: TAK-062; TAK-062 tablets.; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar; SIGE gluten-free bars.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Secondary Outcome Measures :

1. Change in Villous Height to Crypt Depth Ratio (Vh:Cd) from Baseline to Week 24 [ Time Frame: Baseline (Week -4, Run-in Period) 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.
2. Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Adverse Events (SAEs) and Treatment-Related TEAEs [ Time Frame: Up to Week 28 ]
   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.
3. Percentage of Participants with Positive Antidrug Antibodies (ADA) in Serum for TAK-062 [ Time Frame: Up to Week 28 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

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

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

United States, Arizona

Research Solutions of Arizona, PC

Litchfield Park, Arizona, United States, 85340

One of a Kind Clinical Research Center LLC

Paradise Valley, Arizona, United States, 85253

Mayo Clinic- Arizona

Scottsdale, Arizona, United States, 85259

GI Alliance- Sun City

Sun City, Arizona, United States, 85351

Adobe Clinical Research LLC

Tucson, Arizona, United States, 85712

United States, California

Gastroenterology and Liver Institute

Escondido, California, United States, 92025

Om Research LLC

Lancaster, California, United States, 93534

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

Los Angeles, California, United States, 90045

UCLA

Los Angeles, California, United States, 90404

Providence Facey Medical Foundation

Mission Hills, California, United States, 91345

Stanford University School of Medicine

Redwood City, California, United States, 94063

Medical Associates Research Group, Inc.

San Diego, California, United States, 92123

United States, Colorado

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States, 80907

United States, Connecticut

Medical Research Center of Connecticut, LLC 300143562

Hamden, Connecticut, United States, 06518

Central Connecticut Endoscopy Center

Plainville, Connecticut, United States, 06062

United States, Florida

Nature Coast Clinical Research, LLC

Inverness, Florida, United States, 34452

Wellness Clinical Research

Miami Lakes, Florida, United States, 33016

University of Miami Medical Center

Miami, Florida, United States, 33136

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, United States, 32503

St. Johns Center for Clinical Research

Saint Augustine, Florida, United States, 32086

GCP Clinical Research, LLC

Tampa, Florida, United States, 33609

United States, Georgia

Agile Clinical Research Trials

Alpharetta, Georgia, United States, 30022

United States, Illinois

Lemah Creek Clinical Research

Oakbrook Terrace, Illinois, United States, 60181

United States, Indiana

Indiana University -GI

Indianapolis, Indiana, United States, 46202

United States, Iowa

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States, 52242

United States, Louisiana

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Lahey Hospital and Medical

Burlington, Massachusetts, United States, 01805

Hawthorn Medical Associates LLC

South Dartmouth, Massachusetts, United States, 02747

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States, 48047

Revive Research Institute, Inc

Farmington Hills, Michigan, United States, 48334

United States, Minnesota

Mayo Clinic - Rochester

Rochester, Minnesota, United States, 55905

United States, Missouri

Washington University, School of Medicine

Saint Louis, Missouri, United States, 63110

United States, New York

Manhattan Clinical Research, LLC

Manhattan, New York, United States, 10016

New York University Medical Center PRIME

New York, New York, United States, 10016

Blair S Lewis MD

New York, New York, United States, 10032

Rochester Clinical Research

Rochester, New York, United States, 14618

United States, North Carolina

Tryon Medical Partners

Charlotte, North Carolina, United States, 28210

Carolina Digestive Diseases

Greenville, North Carolina, United States, 27834

United States, Ohio

Gastro Health Research

Cincinnati, Ohio, United States, 45219

Cleveland Clinic - Gastroenterology and Hepatology

Cleveland, Ohio, United States, 44195

Dayton Gastroenterology, Inc

Englewood, Ohio, United States, 45415

United States, Pennsylvania

Eastern Pennsylvania Gastroeneterology and Liver Specialists

Allentown, Pennsylvania, United States, 18104

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Gastroenterology Associates, PA

Greenville, South Carolina, United States, 29607

United States, South Dakota

Rapid City Medical Center, LLC

Rapid City, South Dakota, United States, 57701

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

United States, Texas

The Methodist Hospital 150520246

Houston, Texas, United States, 77030

Biopharma Informatic, LLC

Houston, Texas, United States, 77084

Spring Clinical Research

Houston, Texas, United States, 77090

Biopharma Informatic, LLC

McAllen, Texas, United States, 78503

Victoria Gastroenterology

Victoria, Texas, United States, 77904

United States, Virginia

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22903

Blue Ridge Medical Research

Lynchburg, Virginia, United States, 24502

Clinical Research Partners, LLC

Richmond, Virginia, United States, 23220

United States, Washington

Swedish Gastroenterology

Seattle, Washington, United States, 98104

University of Washington Division of Gastroenterology

Seattle, Washington, United States, 98195

Velocity Clinical Research

Spokane, Washington, United States, 99218

Belgium

AZ Sint-Lucas

Brugge, Belgium, 8310

AZ Maria Middelares

Gent, Belgium, 9000

Vitaz

Sint-Niklaas, Belgium, 9100

Canada, Alberta

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta, Canada, T5R 1W2

Canada, Manitoba

St. Boniface Hospital Inc. Section of Nephrology BG 007

Winnipeg, Manitoba, Canada, R2H 2A6

Canada, Ontario

Kensington Screening Clinic

Toronto, Ontario, Canada, M5T 3A9

France

Hopital Rangueil Service de Gastro Enterologie et Nutrition

Toulouse Cedex 09, Haute Garonne, France, 31059

Institut des MICI

Neuilly, Hauts De Seine, France, 92200

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

Saint Etienne, Loire, France, 42055

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

Lille cedex, Nord, France, 59037

Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive

Paris, France, 75015

Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Milano, Italy, 20122

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

Ancona, Italy, 60123

Ospedale Valduce 300205849

Como, Italy, 22100

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine

Palermo, Italy, 90127

Fondazione IRCCS Policlinico San Matteo Sezione di Medicina Interna

Pavia, Italy, 27100

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

Pisa, Italy, 56124

Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia

Roma, Italy, 168

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

Salerno, Italy, 84131

Ospedale Umberto I di Torino S.C. Gastroenterologia

Torino, Italy, 10128

Poland

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

Krakow, Poland, 31-501

ALLMEDICA sp. z o. o.

Nowy Targ, Poland, 34-400

Gabinet Lekarski Bartosz Korczowski

Rzeszow, Poland, 35-302

Centrum Medyczne Medyk

Rzeszow, Poland, 35-326

Warsaw IBD Point Profesor Kierkus

Warszawa, Poland, 00-728

Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie

Warszawa, Poland, 02-172

Melita Medical SP . Z O. O.

Wroclaw, Poland, 50-449

ETG Zamosc

Zamosc, Poland, 22-400

Spain

Vall d'Hebron Research Institute

Barcelona, Spain, 8035

Hospital Universitario Ramon y Cajal Servicio de Gastroenterologia

Madrid, Spain, 28034

Hospital Clinico Universitario Virgen de la Victoria Digestive Service

Malaga, Spain, 29010

Hospital Universitario Virgen Macarena Digestive Service

Sevilla, Spain, 41009

Hospital Universitario Miguel Servet Servicio de Aparato Digestivo

Zaragoza, Spain, 50009

United Kingdom

Royal London Hospital Dept of Gastroenterology

London, Greater London, United Kingdom, E1 1FR

King's College Hospital Dept of Gastroenterology

London, Greater London, United Kingdom, SE5 9RS

John Radcliffe Hospital Dept of Gastroenterology

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Royal Hallamshire Hospital Dept of Gastroenterology

Sheffield, South Yorkshire, United Kingdom, S10 2JF

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, West Yorkshire, United Kingdom, BD9 6RJ

The Ulster Hospital Department of Gastroenterology

Belfast, United Kingdom, BT16 1RH

Sponsors and Collaborators

Takeda

Investigators

• Study Director: Study Director; Takeda

More Information

Additional Information:

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

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT05353985
• Other Study ID Numbers: TAK-062-2001; 2020-005438-14 ( EudraCT Number )
• First Posted: April 29, 2022
• Last Update Posted: March 13, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• URL: https://vivli.org/ourmember/takeda/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:

Drug Therapy

Additional relevant MeSH terms:

Celiac Disease; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases