Study Summary
This trial is testing a new drug to see if it can reduce symptoms and damage caused by celiac disease, in people who are trying to follow a gluten-free diet.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Baseline (Week -4, Run-in Period) to Week 24
Trial Safety
Phase-Based Safety
Trial Design
8 Treatment Groups
Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE Bar
1 of 8
Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE Bar
1 of 8
Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE Bar
1 of 8
Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar
1 of 8
Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE Bar
1 of 8
Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar
1 of 8
Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar
1 of 8
Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar
1 of 8
Experimental Treatment
Non-Treatment Group
377 Total Participants · 8 Treatment Groups
Primary Treatment: TAK-062 · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 12 - 75 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Colorado | 50.0% |
| California | 50.0% |
How old are they?
| < 18 | 100.0% |
What site did they apply to?
| Om Research LLC | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
Why did patients apply to this trial?
- "Searching for help managing celiac disease and immune response, because it's nearly impossible to avoid accidental gluten exposure."
What questions have other patients asked about this trial?
- "Is there a remote option? If not, do you offer a travel stipend?"
How many prior treatments have patients received?
| 0 | 100.0% |
Frequently Asked Questions
Are there still spots open for people who want to participate in this clinical trial?
"Correct. The clinical trial is recruiting patients at present and was first posted on 6/30/2022. 350 patients are needed for the study which is only being conducted at 1 location." - Anonymous Online Contributor
How many test subjects are there in this trial?
"Yes, the information on clinicaltrials.gov points out that this clinical trial is currently seeking candidates. The clinical trial was originally posted on 6/30/2022 and was most recently edited on 9/1/2022. The study is searching for 350 patients between 1 sites" - Anonymous Online Contributor
Could you detail the side effects associated with TAK-062?
"While there is some safety data for TAK-062, it only received a score of 2 because this is a Phase 2 trial and there are no efficacy data." - Anonymous Online Contributor
Does this clinical trial have an age limit for participants?
"The age limit for this research is 12-75 years old." - Anonymous Online Contributor
How do I sign up for the chance to participate in this medical research?
"This clinical trial is looking for 350 patients with celiac disease between the ages of 12 and 75. Patients must meet the following criteria: they must have an adequate understanding of a gluten-free diet, as assessed by a knowledge test; they must have at least one symptom related to gluten exposure that is moderate or greater in severity, as measured by the CDSD; they must be biopsy-confirmed to have celiac disease; they must be HLA-DQ2 and/or HLA-DQ8 positive; they must be in good general health, according to clinical history and physical examination; their BMI must" - Anonymous Online Contributor