TEV-53408: Solution for subcutaneous (sc) injection
Placebo: Solution for subcutaneous (sc) injection
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
Trial sites (21)
Facility
City
Region
Status
Teva Investigational Site 12138
Murrieta
California
Teva Investigational Site 12131
Colorado Springs
Colorado
Teva Investigational Site 12134
Inverness
Florida
Teva Investigational Site 12126
Miami Lakes
Florida
Teva Investigational Site 12135
New Port Richey
Florida
Teva Investigational Site 12130
Atlanta
Georgia
Teva Investigational Site 12133
Marrero
Louisiana
Teva Investigational Site 12132
Clinton Township
Michigan
Teva Investigational Site 12121
Wyoming
Michigan
Teva Investigational Site 12129
Rochester
Minnesota
Teva Investigational Site 12128
New York
New York
Teva Investigational Site 12125
Greenville
North Carolina
Teva Investigational Site 12127
Winston-Salem
North Carolina
Teva Investigational Site 12137
Waco
Texas
Teva Investigational Site 12122
Ogden
Utah
Teva Investigational Site 12123
Lynchburg
Virginia
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
More Teva Branded Pharmaceutical Products R&D LLC trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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