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

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