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

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What is this study about?

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.

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 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 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 Follow-up biopsy

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

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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Pirkanmaan hyvinvointialue	Tampere	Finland
Sfstvc Tomfljekpzo Ot	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	03.06.2025

Trial locations

Investigated drugs:

TEV-53408

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.

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 ID:

2024-517081-42-00

Protocol code:

TV53408-IMM-20042

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?