A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
Purpose
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.
Condition
- Celiac Disease
Eligibility
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TEV-53408 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Teva Investigational Site 12134
Inverness 4159786, Florida 4155751 34452
Inverness 4159786, Florida 4155751 34452
Teva Investigational Site 12133
Marrero 4332628, Louisiana 4331987 70072
Marrero 4332628, Louisiana 4331987 70072
Teva Investigational Site 12129
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Teva Investigational Site 12128
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
Teva Investigational Site 12125
Greenville 4469160, North Carolina 4482348 27834
Greenville 4469160, North Carolina 4482348 27834
Teva Investigational Site 12123
Lynchburg 4771075, Virginia 6254928 24502
Lynchburg 4771075, Virginia 6254928 24502
More Details
- NCT ID
- NCT06807463
- Status
- Recruiting
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC