TAK-062 for Celiac Disease

Vitaz, Sint-Niklaas, Belgium
Celiac DiseaseTAK-062 - Drug
Eligibility
12 - 75
All Sexes
What conditions do you have?
Select

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

1 of 3
Phase 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline (Week -4, Run-in Period) to Week 24

Week 12
Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score from Baseline to Week 12
Week 24
Change in Villous Height to Crypt Depth Ratio (Vh:Cd) from Baseline to Week 24
Up to Week 28
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
Percentage of Participants with Positive Antidrug Antibodies (ADA) in Serum for TAK-062

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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

Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE BarExperimental Group · 2 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, TAK-062 · Intervention Types: DietarySupplement, Drug
Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar and Gluten-free SIGE BarExperimental Group · 3 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 · Intervention Types: DietarySupplement, DietarySupplement, Drug
Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar and Gluten-free SIGE BarExperimental Group · 3 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 · Intervention Types: DietarySupplement, DietarySupplement, Drug
Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE BarExperimental Group · 2 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, TAK-062 · Intervention Types: DietarySupplement, Drug
Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar and Gluten-free SIGE BarExperimental Group · 3 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 · Intervention Types: DietarySupplement, DietarySupplement, Drug
Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE BarPlaceboComparator Group · 3 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 Placebo · Intervention Types: DietarySupplement, DietarySupplement, Drug
Cohort 2: TAK-062 Placebo + Gluten-free SIGE BarPlaceboComparator Group · 2 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, TAK-062 Placebo · Intervention Types: DietarySupplement, Drug
Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar and Gluten-free SIGE BarPlaceboComparator Group · 3 Interventions: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 Placebo · Intervention Types: DietarySupplement, DietarySupplement, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: 5 Weeks
Reporting: baseline (week -4, run-in period) to week 24

Who is running the clinical trial?

TakedaLead Sponsor
1,146 Previous Clinical Trials
4,057,557 Total Patients Enrolled
6 Trials studying Celiac Disease
662 Patients Enrolled for Celiac Disease
Study DirectorStudy DirectorTakeda
1,104 Previous Clinical Trials
481,269 Total Patients Enrolled
3 Trials studying Celiac Disease
727 Patients Enrolled for Celiac Disease

Eligibility Criteria

Age 12 - 75 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You experience moderate or severe gastrointestinal symptoms related to gluten exposure on at least 3 days out of any 7-day period during the screening period. These symptoms need to be confirmed by the investigator and may vary from day to day. You must meet these symptom criteria to undergo certain medical procedures.
Your body mass index (BMI) is within the range of 16 to 40 kg/m^2.

Who else is applying?

What state do they live in?
Colorado50.0%
California50.0%
How old are they?
< 18100.0%
What site did they apply to?
Om Research LLC100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
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?
0100.0%

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

Does this clinical trial have an age limit for participants?

"The age limit for this research is 12-75 years old." - Anonymous Online Contributor

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.