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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am currently on or have recently taken immunosuppressants or steroids.You have been following a gluten-free diet for at least 6 months.I have chronic liver disease or hepatitis B/C.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.You have been following a gluten-free diet for at least 6 months.I have celiac disease that doesn't respond to a gluten-free diet or I have ulcerative jejunitis.My celiac disease is under control with specific blood test levels within the normal range.The investigator may choose to retest participants for specific antibodies to make sure they meet the eligibility criteria.I have previously received TAK-101 in a study or as treatment.I have an autoimmune condition, but it's either thyroid disease or type 1 diabetes under control.I can't tolerate gluten and refuse more gluten challenges after the first.You have other food allergies that would make it difficult for you to take part in the food test.I tested positive for HLA-DQ2 or HLA-DQ8.The doctor may decide to retest for specific antibodies. If you have occasional symptoms, it's okay to participate as long as the doctor thinks your symptoms are under control and have been back to normal for at least 2 weeks before the gluten challenge.You have been following a gluten-free diet for at least 6 months.
- Group 1: Cohort 1, Group B: TAK-101 2 mg/kg + Placebo + TAK-101 2 mg/kg
- Group 2: Cohort 2, Group E: TAK-101 4 mg/kg + Placebo + TAK-101 4 mg/kg
- Group 3: Cohort 2, Group F: TAK-101 4 mg/kg + TAK-101 4 mg/kg + TAK-101 4 mg/kg
- Group 4: Cohort 2, Group E: TAK-101 1 mg/kg + Placebo + TAK-101 1 mg/kg
- Group 5: Cohort 2, Group G: TAK-101 1 mg/kg + TAK-101 1 mg/kg + TAK-101 1 mg/kg
- Group 6: Cohort 1, Group A: Placebo + Placebo + TAK-101 2 mg/kg
- Group 7: Cohort 2, Group D: Placebo + Placebo + TAK-101 1 mg/kg
- Group 8: Cohort 1, Group C: TAK-101 2 mg/kg + TAK-101 2 mg/kg + TAK-101 2 mg/kg
- Group 9: Cohort 2, Group D: Placebo + Placebo + TAK-101 2 mg/kg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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"
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."
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."
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