Clinical trial NCT06807463: A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Celiac Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd)
timeFrame: Baseline, Week 8
measure: Number of Participants With at Least One Treatment-Emergent Adverse Event
timeFrame: Up to Week 28
measure: Number of Participants With at Least One Treatment-Emergent Serious Adverse Event
timeFrame: Up to Week 28
measure: Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI)
timeFrame: Up to Week 28
measure: Number of Participants Who Discontinued From the Study Due to an Adverse Event
timeFrame: Up to Week 28
Secondary outcomes:
measure: Change From Baseline in Intraepithelial Lymphocyte (IEL) Density
timeFrame: Baseline, Week 8
measure: Change From Baseline in the VCIEL score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Teva Investigational Site 12131
state: Colorado
city: Inverness
country: United States
facility: Teva Investigational Site 12134
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 12126
state: Florida
city: New Port Richey
country: United States
facility: Teva Investigational Site 12135
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 12130
state: Georgia
city: Clinton Township
country: United States
facility: Teva Investigational Site 12132
state: Michigan
city: Wyoming
country: United States
facility: Teva Investigational Site 12121
state: Michigan
city: Greenville
country: United States
facility: Teva Investigational Site 12125
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 12127
state: North Carolina
city: Ogden
country: United States
facility: Teva Investigational Site 12122
state: Utah
city: Lynchburg
country: United States
facility: Teva Investigational Site 12123
state: Virginia
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: