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Do you have celiac disease?

Consider joining a clinical trial.

This phase 2 clinical trial is investigating TEV-53408 as a potential treatment for celiac disease. Compensation for time and travel may be available.

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

What is the study medication (TEV-53408)?2023-06-06T19:51:32-07:00

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.

How will the study medication be administered?2023-05-30T10:52:42-07:00

TEV-53408 will be given as a single injection under the skin in the abdomen.

Has the study medication been tested in humans before?2024-11-20T11:31:50-08:00

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.

What is a placebo, and why is it used?2023-05-30T10:55:51-07:00

A placebo is an inactive substance with no therapeutic effect that is used to help determine whether results are due to the study medication.

What is a clinical trial?2024-11-20T10:33:51-08:00

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.

Who is the study sponsor?2023-05-30T10:58:29-07:00

Teva Branded Pharmaceutical Products, Inc.

Where is this study located?2024-11-20T10:34:58-08:00

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.

What are the potential benefits of participating?2023-05-30T11:02:26-07:00

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 I pre-qualify, what happens next?2023-05-30T11:02:55-07:00

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.

Can I change my mind about participating once I am enrolled in the study?2024-11-20T11:35:27-08:00

Yes. Your participation is completely voluntary. You can change your mind and withdraw from the study at any time.

Can I stay in the study if I can’t finish the gluten challenge?2024-11-20T10:35:28-08:00

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.

Will I be given the study medication or placebo?2024-11-20T10:35:49-08:00

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.

How long will my participation in the study last?2024-11-20T10:36:50-08:00

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
Will I have to pay to participate?2024-11-20T11:39:21-08:00

No. All study visits, materials, and medication will be provided to you at no cost.

Will I be reimbursed for study-related travel?2024-11-20T11:39:50-08:00

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.

Will I be compensated for my time?2024-11-20T11:40:39-08:00

Compensation for your time may be available. The study team at your location will provide additional details about this before you agree to participate.

I have additional questions, who can I contact?2024-11-20T11:41:02-08:00

Contact the TEV-CeD2 Study Team at [email protected].

Contact

Contact the TEV-CeD2 Study Team at [email protected].

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