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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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. The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease. A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease. The expected trial duration per participant is approximately 86 weeks.

Key facts

Study ID

NCT06807463

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

50

Starts

2025-03-31

Expected to finish

2027-09-14

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Teva Investigational Site 12138 — Murrieta, California, United States
• Teva Investigational Site 12131 — Colorado Springs, Colorado, United States
• Teva Investigational Site 12134 — Inverness, Florida, United States
• Teva Investigational Site 12126 — Miami Lakes, Florida, United States
• Teva Investigational Site 12135 — New Port Richey, Florida, United States
• Teva Investigational Site 12130 — Atlanta, Georgia, United States
• Teva Investigational Site 12133 — Marrero, Louisiana, United States
• Teva Investigational Site 12132 — Clinton Township, Michigan, United States
• Teva Investigational Site 12121 — Wyoming, Michigan, United States
• Teva Investigational Site 12129 — Rochester, Minnesota, United States
• Teva Investigational Site 12128 — New York, New York, United States
• Teva Investigational Site 12125 — Greenville, North Carolina, United States
• Teva Investigational Site 12127 — Winston-Salem, North Carolina, United States
• Teva Investigational Site 12137 — Waco, Texas, United States
• Teva Investigational Site 12122 — Ogden, Utah, United States
• Teva Investigational Site 12123 — Lynchburg, Virginia, United States
• Teva Investigational Site 78139 — Fitzroy, Australia
• Teva Investigational Site 78140 — Maroochydore, Australia
• Teva Investigational Site 78137 — Midland, Australia
• Teva Investigational Site 40063 — Helsinki, Finland
• Teva Investigational Site 40062 — Tampere, Finland

Full record on ClinicalTrials.gov

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