Assessing TEV-53408 for treating adults with celiac disease
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Trial to Characterize the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease While Undergoing Oral Gluten Exposure
This study is testing a new treatment called TEV-53408 to see if it can help adults with celiac disease feel better when they eat gluten.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. Industry-sponsored |
| Locations | 8 sites (Colorado Springs, Colorado and 7 other locations) |
| Trial ID | NCT06807463 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy and safety of TEV-53408 in adults diagnosed with celiac disease. Participants will receive either TEV-53408 or a placebo over a period of approximately 86 weeks. The primary goal is to determine how well TEV-53408 can reduce gluten-induced enteropathy, while also monitoring its safety profile. The study aims to provide insights into the potential benefits of this treatment for managing celiac disease.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with celiac disease who have been on a gluten-free diet for at least 12 months.
Not a fit: Patients with refractory celiac disease or severe symptoms requiring acute medical care may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of celiac disease by reducing gluten-induced symptoms.
How similar studies have performed: While this approach is novel, similar studies targeting celiac disease have shown promise in developing effective treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Colorado Springs, Colorado and 7 other locations
- Teva Investigational Site 12131 — Colorado Springs, Colorado, United States (Recruiting)
- Teva Investigational Site 12134 — Inverness, Florida, United States (Recruiting)
- Teva Investigational Site 12126 — Miami Lakes, Florida, United States (Recruiting)
- Teva Investigational Site 12130 — Atlanta, Georgia, United States (Recruiting)
- Teva Investigational Site 12121 — Wyoming, Michigan, United States (Recruiting)
- Teva Investigational Site 12125 — Greenville, North Carolina, United States (Recruiting)
- Teva Investigational Site 12127 — Winston-Salem, North Carolina, United States (Recruiting)
- Teva Investigational Site 12122 — Ogden, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Teva U.S. Medical Information
- Email: USMedInfo@tevapharm.com
- Phone: 1-888-483-8279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.