A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
NCT ID: NCT06807463
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2025-03-31
2027-09-14
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TEV-53408
TEV-53408
Solution for subcutaneous (sc) injection
Placebo
Placebo
Solution for subcutaneous (sc) injection
Interventions
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TEV-53408
Solution for subcutaneous (sc) injection
Placebo
Solution for subcutaneous (sc) injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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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
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 78137
Midland, , Australia
Teva Investigational Site 40063
Helsinki, , Finland
Teva Investigational Site 40062
Tampere, , Finland
Countries
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Central Contacts
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Other Identifiers
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2024-517081-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
TV53408-IMM-20042
Identifier Type: -
Identifier Source: org_study_id