Celiac DiseasePhase 2NCT06807463
A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
A Phase 2 study testing TEV-53408 in people with Celiac Disease, run by Teva Branded Pharmaceutical Products R&D LLC at 21 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- TEV-53408
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 31 Mar 2025to 14 Sep 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States16 sites
Teva Investigational Site 12130
Atlanta, Georgia, 30328
Teva Investigational Site 12132
Clinton Township, Michigan, 48038
Teva Investigational Site 12131
Colorado Springs, Colorado, 80907
Teva Investigational Site 12125
Greenville, North Carolina, 27834
Teva Investigational Site 12134
Inverness, Florida, 34452
Teva Investigational Site 12123
Lynchburg, Virginia, 24502
Teva Investigational Site 12133
Marrero, Louisiana, 70072
Teva Investigational Site 12126
Miami Lakes, Florida, 33016
Teva Investigational Site 12138
Murrieta, California, 92563
Teva Investigational Site 12135
New Port Richey, Florida, 34653
Teva Investigational Site 12128
New York, New York, 10032
Teva Investigational Site 12122
Ogden, Utah, 84405
Teva Investigational Site 12129
Rochester, Minnesota, 55905
Teva Investigational Site 12137
Waco, Texas, 76712
Teva Investigational Site 12127
Winston-Salem, North Carolina, 27103
Teva Investigational Site 12121
Wyoming, Michigan, 49519
Australia3 sites
Teva Investigational Site 78139
Fitzroy, 3065
Teva Investigational Site 78140
Maroochydore, 4558
Teva Investigational Site 78137
Midland, 6056
Finland2 sites
Teva Investigational Site 40063
Helsinki, 00100
Teva Investigational Site 40062
Tampere, 33520
About this study
Official title: 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
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.
- Conditions
- Celiac Disease
- Being tested
- TEV-53408, Placebo
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-53408Drug
Solution for subcutaneous (sc) injection
PlaceboDrug
Solution for subcutaneous (sc) injection
| Study group | Role | What they receive |
|---|---|---|
| TEV-53408 | Experimental | Not described Receives: Drug: TEV-53408 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Number of Participants With at Least One Treatment-Emergent Adverse Event
Measured: Up to Week 28
Number of Participants With at Least One Treatment-Emergent Serious Adverse Event
Measured: Up to Week 28
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI)
Measured: Up to Week 28
Number of Participants Who Discontinued From the Study Due to an Adverse Event
Measured: Up to Week 28
Secondary outcomes (2)
Change From Baseline in Intraepithelial Lymphocyte (IEL) Density
Measured: 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.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start31 Mar 2025
- Primary completion2 Oct 2026
- Study completion14 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807463
- Sponsor's protocol ID
- TV53408-IMM-20042
- Other IDs
- 2024-517081-42-00
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.