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Study of TEV-53408 Safety and Effectiveness in Adults with Celiac Disease During Gluten Exposure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying a new medication called TEV-53408 for people with celiac disease. Celiac disease is a condition where eating gluten (a protein found in wheat, rye, and barley) causes damage to the small intestine. The purpose of this study is to evaluate how well TEV-53408 works to protect the intestine from damage when people with celiac disease are exposed to gluten.

The study will test a single dose of TEV-53408 given as a subcutaneous injection (an injection under the skin) compared to a placebo. During the study, participants will need to eat food containing gluten while researchers monitor how their intestines respond to the treatment. The study will last 28 weeks to assess both the effectiveness and safety of the medication.

Participants will undergo medical examinations including an endoscopy (a procedure where a small camera is used to look inside the intestine) to check how the intestinal tissue responds to the treatment. The study will track any changes in the intestinal lining and monitor for any side effects that may occur during the treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and eligibility check

    A duodenal biopsy (examination of small intestine tissue) will be performed to check your eligibility for the study

    Various tests will be conducted, including blood tests to check for celiac disease antibodies and genetic markers

    Your body mass index (BMI) must be between 18.5 and 40

  2. Step 2

    Study medication administration

    You will receive a single dose of either TEV-53408 or placebo through a subcutaneous injection (injection under the skin)

    The medication assignment will be random, and neither you nor the doctor will know which treatment you receive

  3. Step 3

    Gluten challenge period

    You will be required to consume gluten as part of the study protocol

    Your response to gluten exposure will be monitored throughout this period

  4. Step 4

    Follow-up biopsy

    At week 8, another duodenal biopsy will be performed to assess any changes in your intestinal tissue

  5. Step 5

    Safety monitoring period

    Your health will be monitored for a total of 28 weeks after receiving the study medication

    Any side effects or health changes will be recorded during this period

  6. Step 6

    Birth control requirements

    If applicable, you must use effective birth control methods during the study and for 28 weeks after receiving the study medication

    Regular pregnancy tests will be conducted for women who can become pregnant

Who can join the trial?

11 criteria

  • Age between 18 and 65 years
  • Must have been diagnosed with celiac disease for at least 12 months before screening, confirmed by either: - An endoscopy (examination of digestive tract with a camera) and positive antibody tests, or - Meeting specific diagnostic criteria if under 30 years old without biopsy
  • Following a strict gluten-free diet for at least 12 months before screening
  • Have specific blood test results showing controlled disease (tTg IgA below 2 U/mL)
  • Have minimal intestinal damage as shown by specific measurements during an endoscopy
  • No moderate or severe digestive symptoms related to celiac disease during screening
  • Test positive for specific genetic markers (HLA DQ2 or HLA DQ8)
  • Body Mass Index (BMI) between 18.5 and 40
  • Women who can become pregnant must: - Have a negative pregnancy test - Use effective birth control during the study and for 28 weeks after - Not be pregnant, breastfeeding, or planning pregnancy
  • Men with partners who can become pregnant must: - Use condoms during the study and for 28 weeks after - Agree not to donate sperm during this period
  • Must be able to: - Give informed consent - Undergo intestinal biopsies during screening and at week 8 - Follow study requirements and restrictions

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Not having a confirmed diagnosis of Celiac Disease
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Current participation in other clinical trials
  • Use of immunosuppressive medications (drugs that weaken the immune system)
  • Serious heart, liver, or kidney conditions
  • Active infections or ongoing serious illnesses
  • Recent surgery (within the past 3 months)
  • Uncontrolled high blood pressure
  • History of cancer in the past 5 years
  • Substance abuse or alcohol dependency
  • Mental health conditions that could interfere with study compliance
  • Unable to follow a gluten-containing diet as required by the study
  • History of non-compliance with medical treatments
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Investigated drugs

  • TEV-53408

    This is an investigational medication being studied for people with celiac disease. It is administered as a single injection under the skin (subcutaneous) and is being tested to see if it can help reduce intestinal damage caused by gluten exposure in celiac disease patients. The medication aims to protect the intestines when patients with celiac disease are exposed to gluten.

  • Gluten

    This is not a medication but a protein found in wheat, rye, and barley that is being used in controlled amounts during the trial to test the effectiveness of TEV-53408. In this study, participants are deliberately exposed to gluten to evaluate how well the investigational medication protects against gluten-related intestinal damage.

What is already known about the treatment

TEV-53408 - A novel investigational medication administered via subcutaneous injection, currently being studied in Phase 2a clinical trials for the treatment of Celiac Disease. The drug is designed to reduce the inflammatory response triggered by gluten exposure in patients with Celiac Disease, potentially allowing them to better tolerate gluten intake. TEV-53408 represents a new therapeutic approach in the management of Celiac Disease, as it aims to attenuate gluten-induced enteropathy (intestinal damage) through immunological mechanisms, though the exact molecular pathway is still being investigated in clinical trials. The medication belongs to the class of biological response modifiers and is being evaluated as a single-dose treatment with monitoring of effects for up to 28 weeks.

Investigated diseases

Celiac Disease - A long-term digestive disorder where eating gluten triggers an immune response in the small intestine. In people with celiac disease, gluten consumption leads to damage of the small intestine's lining and specifically affects tiny, finger-like projections called villi. When the villi become damaged, the body cannot properly absorb nutrients from food. The condition typically causes inflammation in the small intestine and can result in various digestive symptoms. Over time, continued exposure to gluten can lead to the flattening of the intestinal villi and increased numbers of inflammatory cells in the intestinal lining.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517081-42-00Protocol codeTV53408-IMM-20042Estimated enrolment40 patientsSponsorTeva Branded Pharmaceutical Products R&D LLC

sourced from the EU Clinical Trials Register and site verification

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