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Search / Trial NCT06807463

A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D LLC · Jan 29, 2025

Trial Information

Current as of June 06, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called TEV-53408 to see how well it works and how safe it is for adults with celiac disease. Celiac disease is a condition where eating gluten—a protein found in wheat, barley, and rye—can cause serious health problems. The goal of this trial is to find out if TEV-53408 can help reduce the harmful effects of gluten on the body for those who follow a strict gluten-free diet. Participants in the study will be involved for about 86 weeks, and the trial is currently looking for volunteers.

To be eligible for this trial, participants need to have been diagnosed with celiac disease at least a year ago and have been on a gluten-free diet for the same amount of time. Women who are pregnant or breastfeeding cannot join, and men must take precautions if their partners could become pregnant. There are also several health conditions that could prevent someone from participating, so it’s important to check with the trial team for more details. If you join the trial, you will be closely monitored to ensure your safety throughout the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of celiac disease at least 12 months prior to screening
  • On a gluten-free diet for at least 12 months prior to screening
  • Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period
  • Male participants (including vasectomized) with women of child-bearing potential partners (whether pregnant or not) must use condoms and also agree not to donate sperm for the designated period
  • NOTE - Additional criteria apply, please contact the investigator for more information.
  • Exclusion Criteria:
  • A diagnosis or suspicion of refractory celiac disease
  • History of severe celiac-related symptoms following gluten exposure that require acute medical care or intervention of a health care professional
  • Any other gastrointestinal disease or condition that may interfere with the assessment of celiac disease
  • Current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma
  • Pregnant or lactating woman, or plans to become pregnant during the trial; any man who is considering fathering a child or donating sperm during the trial
  • A history of chronic alcohol or substance abuse disorder within the previous 2 years.
  • An active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening
  • Received or intends to receive any live vaccine within 4 weeks or any non-live vaccine 2 weeks prior to investigational medicinal product administration.
  • NOTE- Additional criteria apply, please contact the investigator for more information

About Teva Branded Pharmaceutical Products R&D Llc

Teva Branded Pharmaceutical Products R&D LLC is a leading global pharmaceutical company dedicated to the development and commercialization of innovative therapies that address unmet medical needs. With a strong focus on research and development, Teva leverages its extensive expertise in both branded and generic medications to deliver high-quality, effective treatments across a range of therapeutic areas. Committed to advancing healthcare through science, Teva collaborates with healthcare professionals, regulatory authorities, and patient communities to ensure the safety and efficacy of its products, ultimately striving to improve patient outcomes worldwide.

Locations

Colorado Springs, Colorado, United States

Wyoming, Michigan, United States

Ogden, Utah, United States

Atlanta, Georgia, United States

Greenville, North Carolina, United States

Miami Lakes, Florida, United States

Winston Salem, North Carolina, United States

Inverness, Florida, United States

New Port Richey, Florida, United States

Clinton Township, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Teva Medical Expert, MD

Study Director

Teva Branded Pharmaceutical Products R&D, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported