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Immunomodulator

TAK-101 for Celiac Disease

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-confirmed CeD that is well-controlled, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD and with immunoglobulin A (IgA) tissue transglutaminase (tTG) <2 × upper limit of normal (ULN) and IgG deamidated gliadin peptide (DGP) <3 × ULN
Must be HLA-DQ2 and/or HLA-DQ8 positive during screening laboratory testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose at weeks 0 and 1 and before gluten challenge at weeks 2, 8, 14, 20, and 24
Awards & highlights

Study Summary

This trial is testing a new medication, TAK-101, to see if it can reduce symptoms and immune activation in adults with celiac disease who are following a gluten-free diet.

Who is the study for?
Adults with celiac disease who have been on a gluten-free diet for at least 6 months can join. They must test positive for HLA-DQ2 or HLA-DQ8 and have mild or no symptoms of active celiac disease, with certain antibody levels below specified limits. People can't join if they've had certain treatments recently, have refractory celiac disease, other serious health conditions, or can't tolerate gluten challenges.Check my eligibility
What is being tested?
The trial is testing TAK-101's ability to prevent immune reactions and symptoms when people with celiac disease eat gluten. Participants will get TAK-101 or a placebo through an IV on two separate days and everyone gets the real treatment after six months.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to the infusion process, gastrointestinal discomfort from the gluten challenge, and any immune responses that TAK-101 is designed to mitigate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My celiac disease is under control with specific blood test levels within the normal range.
Select...
I tested positive for HLA-DQ2 or HLA-DQ8.
Select...
My celiac disease is under control with specific blood test levels within the normal range.
Select...
I tested positive for HLA-DQ2 or HLA-DQ8.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose at weeks 0 and 1 and before gluten challenge at weeks 2, 8, 14, 20, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose at weeks 0 and 1 and before gluten challenge at weeks 2, 8, 14, 20, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Interferon-gamma Spot Forming Units (IFN-γ SFUs) in Human Leukocyte Antigens Density Quotient (HLA-DQ2-positive) Participants Based on Results of a Gliadin-Specific Enzyme-Linked Immunospot (ELISpot) Assay
Secondary outcome measures
Change From Baseline Before Gluten Challenge to 4 hours Post-gluten Challenge in Plasma Interleukin-2 (IL-2) on Day 15 and Weeks 8, 14, and 20
Change From Baseline in CDSD 3-day Peak Nausea Severity Score
Change From Baseline in Nausea Severity as Measured by the Celiac Disease Symptom Diary (CDSD) 3-day Average Score
+3 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: Cohort 2, Group G: TAK-101 1 mg/kg + TAK-101 1 mg/kg + TAK-101 1 mg/kgExperimental Treatment2 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 1 mg/kg IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 1 mg/kg will be given 23 weeks after the second dose at approximately Week 24 (1 mg/kg may not be needed based on review of Cohort 1 data). Cohort 2 would start based on the results of Cohort 1.
Group II: Cohort 2, Group F: TAK-101 4 mg/kg + TAK-101 4 mg/kg + TAK-101 4 mg/kgExperimental Treatment2 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 4 mg/kg IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 4 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Group III: Cohort 2, Group E: TAK-101 4 mg/kg + Placebo + TAK-101 4 mg/kgExperimental Treatment3 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 4 mg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 4 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Group IV: Cohort 2, Group E: TAK-101 1 mg/kg + Placebo + TAK-101 1 mg/kgExperimental Treatment3 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 1 mg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 1 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open the second cohort at the 4 mg/kg dose level i.e. if 4mg/kg Groups E and F are not opened.
Group V: Cohort 2, Group D: Placebo + Placebo + TAK-101 2 mg/kgExperimental Treatment3 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 2 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Group VI: Cohort 2, Group D: Placebo + Placebo + TAK-101 1 mg/kgExperimental Treatment3 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 1 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open the second cohort at the 4 mg/kg dose level i.e. if 4mg/kg Groups E and F are not opened.
Group VII: Cohort 1, Group C: TAK-101 2 mg/kg + TAK-101 2 mg/kg + TAK-101 2 mg/kgExperimental Treatment2 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 2 mg/kg IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 2 mg/kg will be given 23 weeks after the second dose at approximately Week 24.
Group VIII: Cohort 1, Group B: TAK-101 2 mg/kg + Placebo + TAK-101 2 mg/kgExperimental Treatment3 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 2 mg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 2 mg/kg will be given 23 weeks after the second dose at approximately Week 24.
Group IX: Cohort 1, Group A: Placebo + Placebo + TAK-101 2 mg/kgExperimental Treatment3 Interventions
Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 2 milligram per kilogram (mg/kg) will be given 23 weeks after the second dose at approximately Week 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gluten
2015
N/A
~330
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,198 Previous Clinical Trials
4,178,245 Total Patients Enrolled
6 Trials studying Celiac Disease
931 Patients Enrolled for Celiac Disease
Medical Director Clinical ScienceStudy DirectorTakeda
196 Previous Clinical Trials
63,173 Total Patients Enrolled
2 Trials studying Celiac Disease
50 Patients Enrolled for Celiac Disease
Study DirectorStudy DirectorTakeda
1,202 Previous Clinical Trials
489,524 Total Patients Enrolled
5 Trials studying Celiac Disease
1,180 Patients Enrolled for Celiac Disease

Media Library

TAK-101 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04530123 — Phase 2
Celiac Disease Research Study Groups: Cohort 1, Group B: TAK-101 2 mg/kg + Placebo + TAK-101 2 mg/kg, Cohort 2, Group E: TAK-101 4 mg/kg + Placebo + TAK-101 4 mg/kg, Cohort 2, Group F: TAK-101 4 mg/kg + TAK-101 4 mg/kg + TAK-101 4 mg/kg, Cohort 2, Group E: TAK-101 1 mg/kg + Placebo + TAK-101 1 mg/kg, Cohort 2, Group G: TAK-101 1 mg/kg + TAK-101 1 mg/kg + TAK-101 1 mg/kg, Cohort 1, Group A: Placebo + Placebo + TAK-101 2 mg/kg, Cohort 2, Group D: Placebo + Placebo + TAK-101 1 mg/kg, Cohort 1, Group C: TAK-101 2 mg/kg + TAK-101 2 mg/kg + TAK-101 2 mg/kg, Cohort 2, Group D: Placebo + Placebo + TAK-101 2 mg/kg
Celiac Disease Clinical Trial 2023: TAK-101 Highlights & Side Effects. Trial Name: NCT04530123 — Phase 2
TAK-101 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530123 — Phase 2
Celiac Disease Patient Testimony for trial: Trial Name: NCT04530123 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include adults in their forties?

"This study is looking for participants that fall in the age range of 18 to 75 years old."

Answered by AI

What is the latest FDA decision on TAK-101?

"While there is some data suggesting TAK-101 is safe, it only received a score of 2 because this is still a Phase 2 trial and no clinical evidence has been gathered to support efficacy."

Answered by AI

Might I be a good candidate for this research project?

"This trial is open to 108 patients that have celiac disease and meet the following criteria: they must be between 18 and 75 years old, have biopsy-confirmed CeD that is well-controlled (defined as mild or with no ongoing signs or symptoms related to active CeD), have immunoglobulin A (IgA) tissue transglutaminase (tTG) <2 × upper limit of normal (ULN) and IgG deamidated gliadin peptide (DGP) <3 × ULN. Participants may be retested for IgA tTG and IgG DGP to"

Answered by AI

Are patients currently being enrolled in this research?

"The clinical trial detailed on clinicaltrials.gov is no longer recruiting patients as of their last update on October 18th, 2022. This particular study was originally posted on June 23rd, 2022. There are, however, 31 other similar studies that are actively looking for participants right now."

Answered by AI

Are there different hospitals participating in this research project across North America?

"This study has 31 locations total, with 4 main sites: South Edmonton Gastroenterology in Edmonton, Alberta; Saint Boniface General Hospital in Winnipeg, Manitoba; CHUM Centre de Recherche in Montreal, Virginia."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
British Columbia
Other
How old are they?
18 - 65
What site did they apply to?
Sweet Hope Research Specialty, Inc.
Precision Research Institute, LLC
South Edmonton Gastroenterology
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

Is there a remote option, and if not, is there a travel stipend? It is possible to release the coealic disease's drug before 2024?
PatientReceived no prior treatments

Why did patients apply to this trial?

I saw your study on youtube and I am very excited to know about your drug.
PatientReceived no prior treatments
I hate having to follow a gluten free diet and want to help find a treatment.
PatientReceived no prior treatments
I would like to help to get a treatment approved so us with celiac disease could live a more normal lifestyle sooner than later.
PatientReceived no prior treatments
I am hoping very much for the cure so I can live a normal life without constant anxiety and stress about being exposed to gluten.
PatientReceived 1 prior treatment
I'm looking for help managing Celiac disease and the immune response, because avoiding accidental gluten exposure is nearly impossible.
PatientReceived 1 prior treatment
~55 spots leftby Jan 2026