Protected: Home2025-01-29T14:47:14-08:00

Do you have celiac disease?

Consider joining a clinical trial.

This phase 2 clinical trial is exploring an investigational drug for celiac disease. Compensation for time and travel may be available.

Requirements

18 – 65 years old

Diagnosed with celiac disease for at least 12 months

On a gluten-free diet for at least 12 months

About

The TEV-CeD2 Study aims to find out if a single injection of TEV-53408, the investigational drug, is safe and effective in adults with celiac disease compared to a placebo (an inactive substance with no therapeutic effect).

The study will assess if the study drug reduces intestinal damage and inflammation attributed to celiac disease after gluten consumption.

What to expect with participation in this research study:

If you qualify and choose to participate, you will have approximately 22 visits over 86 weeks (~1.5 years). Some of these visits may be completed from home if you prefer.

You will be closely monitored for any study treatment effects and changes in your symptoms throughout the entire study.

Screening Period (Up to 6 weeks)

Your eligibility will be based on thorough health assessments, medical record review, and an endoscopy.

Treatment Period (28 weeks)

Dosing Visit (Visit 2):
You will receive one injection of TEV-53408 or placebo.

6-Week Gluten Challenge (Visit 3 to Visit 6):
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 who will prescribe medications to reduce your symptoms. If symptoms are not tolerable, you may stop the gluten challenge and still participate in the study. An endoscopy will be done at the end of the gluten challenge period.

Washout Period (Visit 7 to Visit 11):
Every 4 weeks, you will either visit the study site for assessments or have home visits with the study staff.

Follow-Up Period (52 weeks)

Visit 12 to Visit 22: 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 drug (TEV-53408)?2025-01-28T09:48:59-08:00

The study drug, 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 help reduce intestinal inflammation and tissue damage associated with celiac disease.

How will the study drug be administered?2025-01-28T09:49:16-08:00

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

Has the study drug been tested in humans before?2025-01-28T09:56:52-08:00

Yes. TEV-53408 has been tested in healthy people and in a small number of patients with celiac disease in previous studies, and the drug was shown to be safe and well-tolerated.

What is a placebo, and why is it used?2025-01-28T09:57:23-08:00

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

What is a clinical trial?2025-01-28T09:57:46-08:00

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.

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

Teva Branded Pharmaceutical Products, Inc.

Where is this study located?2025-01-28T09:58:21-08:00

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.

What are the potential benefits of participating?2025-01-28T09:58:59-08:00

Participating in a clinical trial is a way to help develop alternative treatment options for celiac disease. You will be part of advancing celiac disease research, while receiving study-related 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?2025-01-28T10:00:14-08:00

Yes. If you cannot tolerate the gluten challenge, you can speak to the study doctor who will prescribe medications to treat your symptoms. If symptoms are not tolerable, you may stop the gluten challenge and still participate in the study.

Will I be given the study drug or placebo?2025-01-28T10:00:40-08:00

In this study, participants will be randomly assigned (by chance, like flipping a coin) to receive the study drug or placebo. You will have a 50% (1 in 2) chance of receiving the study drug and a 50% (1 in 2) chance of receiving placebo. 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?2025-01-28T10:01:40-08:00

You will be in the study for about 86 weeks (approximately 1.5 years).

Will I have to pay to participate?2025-01-28T10:02:08-08:00

No. All study tests, procedures, and medication will be provided to you at no cost.

Will I be reimbursed for study-related travel?2025-01-28T10:02:28-08:00

Reimbursement for 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].

Questions?

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

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