Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

June 23, 2022

Primary Completion Date

January 19, 2026

Study Completion Date

January 19, 2026

Conditions
Celiac Disease
Interventions
DRUG

Placebo

TAK-101 placebo-matching intravenous infusion

DRUG

TAK-101

TAK 101 intravenous infusion

DIETARY_SUPPLEMENT

Gluten

Powder form (vital wheat gluten)

Trial Locations (48)

632

Optimal Clinical Trials - North, Auckland

930

Silverdale Medical, Silverdale

1010

Optimal Clinical Trials - Central, Grafton

1016

Southern Clinical Trials Totara, New Lynn

5010

Capital, Coast and Hutt Valley - Wellington Regional Hospital, Boulcott

5018

Lakeland Clinical Trials Wellington, Upper Hutt

6021

P3 Research Limited (Wellington), Wellington

6056

St John of God Midland, Midland

10029

Mount Sinai, New York

10032

Columbia University Medical Center. New York Presbyterian Hospital, New York

11096

Basil Clinical, Inwood

28546

East Carolina Gastroenterology, PA, Jacksonville

30328

Agile Clinical Research Trials, Atlanta

33609

GCP Clinical Research, LLC, Tampa

47150

Berkshire Medical Center, New Albany

Gastroenterology Health Partners, PLLC, New Albany

48048

Clinical Research Institute of Michigan, LLC, Chesterfield

Wellness Clinical Research, Chesterfield

55905

Mayo Clinic - Rochester, Rochester

60527

Lemah Creek Clinical Research, Burr Ridge

61107

Gastroenterology Associates, PA, Rockford

Rockford Gastroenterology Associates, Ltd., Rockford

78628

Amel Med LLC, Georgetown

80907

Asthma and Allergy Associates, PC, Colorado Springs

84403

Care Access Research - Salt Lake City, Ogden

85258

One of a Kind Clinical Research Center LLC, Scottsdale

87102

Albuquerque Clinical Trials, Inc., Albuquerque

90160

Momentum Clinical Research Dunedin, Dunedin

92025

Gastroenterology and Liver Institute, Escondido

92064

Cadena Care Institute, Inc., Poway

02111

Boston Specialists, Boston

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01201

Berkshire Medical Center, Inc., Pittsfield

02904

GI Alliance-Rhode Island, Providence

VIC 3050

Royal Melbourne Hospital, Parkville

NSW 2019

Emeritus Research, Sydney, Botany

QLD 4740

Coral Sea Clinical Research Institute, North Mackay

QLD 4102

Princess Alexandra Hospital, Woolloongabba

VIC 3124

Emeritus Research, Melbourne, Camberwell

VIC 3076

The Northern Hospital, Epping

VIC 3065

St Vincent's Hospital Melbourne, Fitzroy

QLD 4101

Mater Hospital Brisbane, South Brisbane

T5R 1W2

Gastroenterology and Internal Medicine Research Institute (GIRI), Edmonton

V8V 3M9

PerCuro Clinical Research Ltd., Victoria

L8S4K1

McMaster University, Hamilton

P1B 2H3

Scott Shulman Medicine Professional Corporation, North Bay

G1V 4T3

DIEX Recherche Quebec Inc., Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY