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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Teva Investigational Site 12138
Murrieta, California, United States
Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd)
Vh:Cd is used to assess the severity of celiac disease. It is calculated by dividing the villous height by the crypt depth. A lower ratio indicates more damage.
Time frame: Baseline, Week 8
Number of Participants With at Least One Treatment-Emergent Adverse Event
Time frame: Up to Week 28
Number of Participants With at Least One Treatment-Emergent Serious Adverse Event
Time frame: Up to Week 28
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI)
Time frame: Up to Week 28
Number of Participants Who Discontinued From the Study Due to an Adverse Event
Time frame: Up to Week 28
Change From Baseline in Intraepithelial Lymphocyte (IEL) Density
Time frame: Baseline, Week 8
Change From Baseline in the VCIEL score
VCIEL score is a calculation using the standardized Vh:Cd and standardized IEL. The standardized Vh:Cd is calculated as the difference between the mean Vh:Cd subtracted from each Vh:Cd divided by the Vh:Cd standard deviation. The standardized IEL is calculated as the difference between the mean IEL subtracted from each IEL divided by the IEL standard deviation. VCIEL is the standardized Vh:Cd minus the standardized IEL.
Time frame: Baseline, Week 8
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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
...and 11 more locations