TEV-53408 for Celiac Disease

Recruiting at 17 trial locations

Overseen By Teva U.S. Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Must not be taking: Antibiotics, Antivirals, Antifungals

Disqualifiers: Refractory celiac, Malignancy, Alcohol abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called TEV-53408, an experimental therapy for celiac disease. The main goal is to determine if TEV-53408 can reduce intestinal damage caused by gluten in individuals with celiac disease. The trial also assesses the treatment's safety for participants. It seeks individuals who have had celiac disease for at least a year and are already following a gluten-free diet. Participants will be involved for about 86 weeks. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in celiac disease treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to contact the trial investigator for more details.

Is there any evidence suggesting that TEV-53408 is likely to be safe for humans?

Research shows that TEV-53408 is being tested for safety in adults with celiac disease. Although specific safety data from earlier studies is unavailable, the Phase 2 trial status indicates that TEV-53408 has passed initial safety tests. Treatments reaching this phase are generally considered reasonably safe for humans.

The FDA has granted the drug Fast Track status, a designation often given to treatments for serious conditions that show potential benefits. While this does not directly prove the drug's safety, it highlights its promise and the need for effective celiac disease treatments.

Overall, although hard safety data is not yet available, the trial phase and Fast Track status suggest that TEV-53408 is expected to be well-tolerated. Participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for celiac disease?

Unlike the standard care for celiac disease, which mainly involves a strict gluten-free diet, TEV-53408 offers a new approach by potentially targeting the underlying immune response. Most current treatments rely on dietary management, but TEV-53408 works differently by addressing the body's reaction to gluten, aiming to reduce symptoms more effectively. Researchers are excited about TEV-53408 because it could offer relief beyond what diet changes provide, making life easier for those struggling with this condition.

What evidence suggests that TEV-53408 might be an effective treatment for celiac disease?

Research has shown that TEV-53408, which participants in this trial may receive, is designed to help people with celiac disease by targeting a protein called interleukin-15 (IL-15). This protein triggers the immune response that harms the gut when someone with celiac disease consumes gluten. By blocking IL-15, TEV-53408 may reduce this immune reaction and aid in gut healing. Although detailed results from human trials are still being gathered, this method appears promising because it targets a key part of the disease process. Early studies aim to determine if TEV-53408 is safe and effective in reducing gut damage caused by gluten. ^{1 2 3 4 6}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

Adults with celiac disease who have been diagnosed for at least a year and on a gluten-free diet for the same duration. Women can't be pregnant or planning pregnancy, and men must use condoms if their partners are of child-bearing potential.

Inclusion Criteria

I have been on a gluten-free diet for at least 12 months.

I was diagnosed with celiac disease over a year ago.

I understand there may be more criteria to meet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TEV-53408 or placebo while undergoing oral gluten exposure to assess efficacy and safety

8 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants continue to be monitored for long-term safety and efficacy outcomes

74 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEV-53408

Trial Overview

The trial is testing TEV-53408's effectiveness in reducing gluten-induced damage in adults with celiac disease compared to a placebo. Participants will be monitored over approximately 86 weeks to assess both efficacy and safety.

How Is the Trial Designed?

Group I: TEV-53408 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Teva Branded Pharmaceutical Products R&D LLC

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06807463

A Trial to Assess the Efficacy and Safety of TEV-53408 in ...

The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.

2.

ir.tevapharm.com

ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-Celiac-Disease-Candidate-Granted-Fast-Track-Designation-by-US-FDA/default.aspx

Teva Celiac Disease Candidate Granted Fast Track ...

TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease. Fast Track is an ...

3.

celiac.org

celiac.org/2025/06/12/new-phase-2-clinical-trial-tev-ced2-study/

New Phase 2 Clinical Trial: TEV-CeD2 Study

This research study aims to find out if a single injection of the study drug is safe and effective in adults with celiac disease compared to a ...

4.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/595055

A Trial to Assess the Efficacy and Safety of TEV-53408 in ...

The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.

5.

gastroenterologyadvisor.com

gastroenterologyadvisor.com/news/anti-interleukin-15-antibody-fast-tracked-for-celiac-disease/

Anti-Interleukin-15 Antibody Fast Tracked for Celiac Disease

TEV-53408 is designed to inhibit IL-15, reducing the immune response to gluten and the subsequent intestinal inflammation in patients with ...

6.

pharmacytimes.com

pharmacytimes.com/view/fda-grants-fast-track-designation-to-celiac-disease-candidate

FDA Grants Fast Track Designation to Drug Candidate ...

TEV-53408, an anti-IL-15 antibody, received FDA fast track designation for celiac disease treatment, highlighting its potential and unmet ...