Do you have celiac disease?
Consider joining a clinical trial.
Requirements
18 – 75 years old
Biopsy-confirmed celiac disease
On a gluten-free diet for 12+ months
About
The TEV-CeD2 Study aims to find out if a single injection of the study medication is safe and effective in adults with celiac disease compared to a placebo (an inactive substance with no therapeutic effect), before and after consuming gluten.
TEV-53408 is an antibody designed to block interleukin-15 with the goal of preventing intestinal damage and symptoms that occur when people with celiac disease ingest gluten.
What to expect with participation in this research study:
If you qualify and choose to participate, you will have 22 visits over about 84 weeks, and 7 of these visits may be completed from home.
You will be closely monitored for any study treatment effects and changes in your symptoms throughout the entire study.
Screening (1 visit)
Your eligibility will be based on thorough health assessments, medical record review, and an endoscopy.
Dosing (1 visit)
You will receive one injection of TEV-53408 or placebo.
Gluten Challenge (3 visits)
You will consume 3g of gluten every day for 6 weeks. If you are unable to complete the gluten challenge, you can speak to the study doctor and stop consuming the gluten for the remainder of the study.
Observational Period (6 visits)
You will have an endoscopy and be monitored for study treatment effects and changes in your symptoms.
Follow-Up Period (11 visits)
Every 4-8 weeks, you will either visit the study site for assessments or have home visits with the study staff.
FAQs
The study medication, TEV-53408, is an antibody designed to block interleukin-15 (IL-15). In celiac disease patients, gluten consumption results in the production of IL-15 which triggers intestinal inflammation, leading to destruction of intestinal cells. The goal of TEV-53408 is to prevent intestinal damage and symptoms that occur when people with celiac disease ingest gluten.
TEV-53408 will be given as a single injection under the skin in the abdomen.
Yes. TEV-53408 has been tested in people with celiac disease in a phase 1 study, and the medication was shown to be safe and well-tolerated.
A placebo is an inactive substance with no therapeutic effect that is used to help determine whether results are due to the study medication.
A clinical trial is a study that helps researchers determine if a new treatment is safe and effective. All medications must go through multiple phases of clinical trials before they can be approved for the public. The TEV-CeD2 Study is a phase 2a clinical trial, which means the study medication has already been tested in healthy volunteers and a small group of patients with celiac disease. The purpose of this trial is to determine the safety and effectiveness of the study medication compared to a placebo.
Teva Branded Pharmaceutical Products, Inc.
This study has multiple locations across the US. For more information about the study site locations, please complete the screening survey to see if you may qualify. If you live near a study site, you will be invited to schedule a phone call with a study team representative to discuss your eligibility, potential participation, and the nearest study site location.
Participating in a clinical trial is the best way to help develop alternative treatment options for celiac disease. You will be an important part of improving the future of celiac disease treatment, while receiving cutting-edge medical care at no cost to you.
If you pre-qualify through the online screening survey and live near a study clinic, you will be invited to schedule a phone call with a study representative to discuss your eligibility and potential participation. If you are interested, you will be contacted by the study clinic to schedule a screening visit. At this visit, you will speak to the study doctor and receive all the information you need to decide if you want to participate.
Yes. Your participation is completely voluntary. You can change your mind and withdraw from the study at any time.
Yes. If you cannot tolerate the gluten challenge, you can speak to the study doctor about your symptoms and stop consuming the gluten for the remainder of the study.
In this study, 50% of participants will be randomly assigned to receive the study medication. To make sure the results are not influenced by anyone, neither you nor the study team will know which group you are in, unless there is an urgent medical need.
Once you are enrolled in the study, your participation will last about 80 weeks:
- Screening (Visit 1)
- Dosing (Visit 2): takes place during Week 0
- Gluten challenge (Visits 3-5): takes place during Weeks 2-7
- Observational period (Visits 6-11): takes place during Weeks 8-28
- Follow-up period (Visits 12-22): takes place during Weeks 29-80
No. All study visits, materials, and medication will be provided to you at no cost.
Reimbursement for eligible study-related travel may be available. The study team at your location will provide additional details about this before you agree to participate.
Compensation for your time may be available. The study team at your location will provide additional details about this before you agree to participate.
Contact the TEV-CeD2 Study Team at [email protected].
Contact
Contact the TEV-CeD2 Study Team at [email protected].