RECRUITINGPhase 2INTERVENTIONAL
A Trial to Assess the Efficacy and Safety of TEV-53408 in 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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
TEV-53408
Solution for subcutaneous (sc) injection
DRUG
Placebo
Solution for subcutaneous (sc) injection
Locations (20)
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