Celiac Disease
Conditions
Brief summary
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.
Interventions
DRUGTEV-53408
Solution for subcutaneous (sc) injection
DRUGPlacebo
Solution for subcutaneous (sc) injection
Sponsors
Teva Branded Pharmaceutical Products R&D LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd) | Baseline, Week 8 | 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. |
| Number of Participants With at Least One Treatment-Emergent Adverse Event | Up to Week 28 | — |
| Number of Participants With at Least One Treatment-Emergent Serious Adverse Event | Up to Week 28 | — |
| Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI) | Up to Week 28 | — |
| Number of Participants Who Discontinued From the Study Due to an Adverse Event | Up to Week 28 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraepithelial Lymphocyte (IEL) Density | Baseline, Week 8 | — |
| Change From Baseline in the VCIEL score | Baseline, Week 8 | 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. |
Countries
Australia, Finland, United States
Contacts
STUDY_DIRECTORTeva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D LLC
Outcome results
None listed