TAK-101 for Celiac Disease
Recruiting at 116 trial locations
TS
TC
AR
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Overseen ByStephanie Moleski
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Takeda
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a drug called TAK-101, given through an IV, to help adults with celiac disease who still have symptoms despite following a gluten-free diet. The drug aims to reduce these symptoms by changing how the immune system reacts to gluten. TAK-101 is designed to induce gluten-specific tolerance by encapsulating gluten protein in negatively charged nanoparticles. Participants will receive the drug at different times and doses to see how well it works and how safe it is.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or corticosteroids, you may need to stop them, as ongoing treatment with these is not allowed.
How is the drug TAK-101 different from other treatments for celiac disease?
Who Is on the Research Team?
SD
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
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.Inclusion Criteria
My celiac disease is under control with specific blood test levels within the normal range.
I tested positive for HLA-DQ2 or HLA-DQ8.
You can still join the study if you have occasional symptoms, as long as they are well managed and have returned to normal for at least 2 weeks before the gluten challenge.
See 6 more
Exclusion Criteria
I am currently on or have recently taken immunosuppressants or steroids.
I have chronic liver disease or hepatitis B/C.
I have celiac disease that doesn't respond to a gluten-free diet or I have ulcerative jejunitis.
See 5 more
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive TAK-101 or placebo infusions on Day 1 and Day 8, followed by gluten challenges and a final infusion at Week 24
24 weeks
Multiple visits including Day 1, Day 8, and Week 24
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 weeks
Final visit after last dose
What Are the Treatments Tested in This Trial?
Interventions
- TAK-101
Trial Overview 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.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GEExperimental Treatment2 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE 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 12.5 µg/kg GE 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 II: Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GEExperimental 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 12.5 µg/kg GE 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 Cohort 2 at the 50 µg/kg GE dose level.
Group III: Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GEExperimental Treatment2 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE 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 50 µg/kg GE 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 A: Placebo + Placebo + TAK-101 25 µg/kg GEExperimental 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 25 µg/kg GE 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 V: Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GEExperimental Treatment2 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE 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 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Group VI: Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GEExperimental Treatment3 Interventions
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/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 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Group VII: Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GEExperimental 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 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
Published Research Related to This Trial
The study identified a significant relationship between the presence of TCRγδ+ T cells and the absence of IL4-producing T cells in the intestinal mucosa of children with overt celiac disease (CD), suggesting these cells play a crucial role in the progression from potential-CD to overt-CD.
The changes in these T cell populations correlate with the severity of intestinal mucosal lesions, indicating that monitoring TCRγδ+ and IL4+ T cells could serve as potential biomarkers for disease progression and targets for new treatments in celiac disease.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Intestinal Cellular Biomarkers of Mucosal Lesion Progression in Pediatric Celiac Disease.Vitale, S., Maglio, M., Picascia, S., et al.[2021]
A point-of-care test (POCT) based on IgA/IgG-deamidated gliadin peptide showed a sensitivity of 67.1% in detecting persistent villous atrophy (VA) in celiac disease, which is higher than other surrogate markers like tissue transglutaminase (TTG) and endomysial antibodies (EMA).
The POCT could offer a non-invasive and immediate assessment of mucosal healing during follow-up consultations, potentially improving patient management in celiac disease without the need for invasive duodenal biopsies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The Role of an IgA/IgG-Deamidated Gliadin Peptide Point-of-Care Test in Predicting Persistent Villous Atrophy in Patients With Celiac Disease on a Gluten-Free Diet.Lau, MS., Mooney, PD., White, WL., et al.[2018]
In a study of 220 infants at genetic risk for celiac disease (CeD), early production of anti-native gliadin antibodies (AGA-IgA) was identified as a potential marker for tolerance, as 15.3% of healthy controls produced these antibodies without developing celiac disease.
The research also found that changes in gene expression and serum cytokine levels occurred before the appearance of more specific antibodies (anti-tTG), indicating that these immunological events may precede the development of villous atrophy in CeD.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Antibody Profile, Gene Expression and Serum Cytokines in At-Risk Infants before the Onset of Celiac Disease.Auricchio, R., Galatola, M., Cielo, D., et al.[2023]
Citations
Intestinal Cellular Biomarkers of Mucosal Lesion Progression in Pediatric Celiac Disease. [2021]
The Role of an IgA/IgG-Deamidated Gliadin Peptide Point-of-Care Test in Predicting Persistent Villous Atrophy in Patients With Celiac Disease on a Gluten-Free Diet. [2018]
Antibody Profile, Gene Expression and Serum Cytokines in At-Risk Infants before the Onset of Celiac Disease. [2023]
A Comprehensive Review of Celiac Disease/Gluten-Sensitive Enteropathies. [2020]
Value of IgA tTG in Predicting Mucosal Recovery in Children With Celiac Disease on a Gluten-Free Diet. [2021]
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