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Protein Tyrosine Kinase Inhibitor
TAK-062 for Celiac Disease
Phase 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an adequate comprehension of a GFD assessed by completion of a knowledge test after viewing of educational materials.
Has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to gluten exposure. The CeD-related symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE).
Timeline
Screening 4 weeks
Treatment 5 weeks
Follow Up 3 days
Awards & highlights
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.
Who is the study for?
This trial is for individuals with celiac disease who have been on a gluten-free diet for at least 12 months, are experiencing moderate to severe gastrointestinal symptoms due to gluten exposure, and have small intestinal damage. Participants must be HLA-DQ2 or HLA-DQ8 positive, understand the gluten-free diet well, and maintain their current dietary and medical regimens throughout the study.Check my eligibility
What is being tested?
The trial tests TAK-062's effectiveness in reducing symptoms of celiac disease and healing intestinal damage caused by inadvertent gluten exposure compared to a placebo. It involves simulated accidental ingestion of gluten through bars that either contain or do not contain gluten.See study design
What are the potential side effects?
While specific side effects of TAK-062 are not listed here, participants may experience reactions related to the treatment or placebo similar to their usual celiac symptoms when exposed to gluten.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had moderate or severe GI symptoms related to gluten at least 3 days in a week.
Select...
Your body mass index (BMI) is within the range of 16 to 40 kg/m^2.
Select...
I will not change my diet, medications, or supplements during the study.
Timeline
Screening ~ 4 weeks7 visits
Treatment ~ 5 weeks47 visits
Follow Up ~ 3 days1 visit
Screening ~ 4 weeks
Treatment ~ 5 weeks
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score from Baseline to Week 12
Secondary outcome measures
Change in Villous Height to Crypt Depth Ratio (Vh:Cd) from Baseline to Week 24
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
Percentage of Participants with Positive Antidrug Antibodies (ADA) in Serum for TAK-062
Trial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE BarExperimental Treatment3 Interventions
TAK-062 Dose 3, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Group II: Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE BarExperimental Treatment3 Interventions
TAK-062 Dose 2, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Group III: Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE BarExperimental Treatment2 Interventions
TAK-062 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Group IV: Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE BarExperimental Treatment2 Interventions
TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Group V: Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE BarExperimental Treatment3 Interventions
TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. Participants also receive gluten-free bar during the run-in period.
Group VI: Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE BarPlacebo Group3 Interventions
TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks. Participants also receive gluten-free bar during the run-in period.
Group VII: Cohort 2: TAK-062 Placebo + Gluten-free SIGE BarPlacebo Group2 Interventions
TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Group VIII: Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE BarPlacebo Group3 Interventions
TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten and gluten free bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,648 Total Patients Enrolled
6 Trials studying Celiac Disease
662 Patients Enrolled for Celiac Disease
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
488,976 Total Patients Enrolled
5 Trials studying Celiac Disease
905 Patients Enrolled for Celiac Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is within the range of 16 to 40 kg/m^2.I do not have inflammatory GI disorders or autoimmune diseases, except well-controlled thyroid disease or type 1 diabetes.I will not change my diet, medications, or supplements during the study.I have type 2 refractory celiac disease or ulcerative jejunitis.I have been using a non-aspirin NSAID for more than a week.You are allergic to any of the following foods: tapioca syrup, oats, almonds, rice crisp, chocolate, almond, butter, wheat gluten, cocoa butter, oat flour, glycerin, sunflower lecithin, salt, and natural flavors. You also experience severe symptoms after eating a gluten-free SIGE bar during the screening process.I have HIV or hepatitis B/C, or a significant liver condition.I use digestive aids other than lactase but haven't changed my probiotics before or during the study.I have used medication for GI symptoms like nausea or diarrhea in the last 2 weeks.I have had moderate or severe GI symptoms related to gluten at least 3 days in a week.I am positive for HLA-DQ2 or HLA-DQ8.I am positive for HLA-DQ2 or HLA-DQ8.I am not currently on, nor have I been on systemic immunosuppressants or corticosteroids in the last 12 weeks.I have needed treatment for microscopic colitis in the last 6 months.I have used medications in the last 3 months that can affect my intestines.I have or might have had COVID-19 in the last month, or my symptoms haven't gone away.I have had moderate to severe GI symptoms related to gluten exposure.Your body mass index (BMI) falls between 16 and 35 kg/m^2.I haven't had a severe stomach infection needing ER, hospital, or antibiotics in the last 6 months.You have had an allergic or adverse reaction to any of the ingredients in TAK-062 or the placebo.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE Bar
- Group 2: Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar
- Group 3: Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar
- Group 4: Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE Bar
- Group 5: Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE Bar
- Group 6: Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE Bar
- Group 7: Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE Bar
- Group 8: Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 4 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 5 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Celiac Disease Patient Testimony for trial: Trial Name: NCT05353985 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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"
Answered by AI
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."
Answered by AI
Does this clinical trial have an age limit for participants?
"The age limit for this research is 12-75 years old."
Answered by AI
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"
Answered by AI
Who else is applying?
What state do they live in?
California
Wisconsin
Colorado
Other
How old are they?
< 18
What site did they apply to?
Om Research LLC
Nature Coast Clinical Research, LLC
GCP Clinical Research, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
To help me ! To help find a cure for celiac. I am in pain and need some help.
PatientReceived no prior treatments
I want to help find a cure for celiacs - especially as my son has it. There are no current medications for people with celiac disease so I would love to be part of the cause to find one!
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Is there a remote option? If not, do you offer a travel stipend? How effective has the new medication been in trials on animals if any have been done?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- GCP Clinical Research, LLC: < 48 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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