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
2 other identifiers
interventional
50
3 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2025
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedStudy Start
First participant enrolled
March 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 14, 2027
April 8, 2026
April 1, 2026
1.5 years
January 29, 2025
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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.
Baseline, Week 8
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 Outcomes (2)
Change From Baseline in Intraepithelial Lymphocyte (IEL) Density
Baseline, Week 8
Change From Baseline in the VCIEL score
Baseline, Week 8
Study Arms (2)
TEV-53408
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Teva Investigational Site 12138
Murrieta, California, 92563, United States
Teva Investigational Site 12131
Colorado Springs, Colorado, 80907, United States
Teva Investigational Site 12134
Inverness, Florida, 34452, United States
Teva Investigational Site 12126
Miami Lakes, Florida, 33016, United States
Teva Investigational Site 12135
New Port Richey, Florida, 34653, United States
Teva Investigational Site 12130
Atlanta, Georgia, 30328, United States
Teva Investigational Site 12133
Marrero, Louisiana, 70072, United States
Teva Investigational Site 12132
Clinton Township, Michigan, 48038, United States
Teva Investigational Site 12121
Wyoming, Michigan, 49519, United States
Teva Investigational Site 12129
Rochester, Minnesota, 55905, United States
Teva Investigational Site 12128
New York, New York, 10032, United States
Teva Investigational Site 12125
Greenville, North Carolina, 27834, United States
Teva Investigational Site 12127
Winston-Salem, North Carolina, 27103, United States
Teva Investigational Site 12137
Waco, Texas, 76712, United States
Teva Investigational Site 12122
Ogden, Utah, 84405, United States
Teva Investigational Site 12123
Lynchburg, Virginia, 24502, United States
Teva Investigational Site 78139
Fitzroy, 3065, Australia
Teva Investigational Site 78140
Maroochydore, 4558, Australia
Teva Investigational Site 78137
Midland, 6056, Australia
Teva Investigational Site 40063
Helsinki, 00180, Finland
Teva Investigational Site 40062
Tampere, 33520, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Teva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2025
First Posted
February 4, 2025
Study Start
March 31, 2025
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
September 14, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.