A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease

Phase 2

Recruiting

• Conditions: Celiac Disease
• Interventions: Drug: TEV-53408; Drug: Placebo

• Registration Number: NCT06807463
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-04
• Study Start: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-09-15
• Study Completion: 2027-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEV-53408	TEV-53408	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Teva Investigational Site 12134; 🇺🇸 Inverness, Florida, United States

Teva Investigational Site 12126; 🇺🇸 Miami Lakes, Florida, United States

Teva Investigational Site 12131; 🇺🇸 Colorado Springs, Colorado, United States

Teva Investigational Site 12130; 🇺🇸 Atlanta, Georgia, United States

Teva Investigational Site 12121; 🇺🇸 Wyoming, Michigan, United States

Teva Investigational Site 12125; 🇺🇸 Greenville, North Carolina, United States

Teva Investigational Site 12127; 🇺🇸 Winston-Salem, North Carolina, United States

Teva Investigational Site 12122; 🇺🇸 Ogden, Utah, United States