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

Teva Branded Pharmaceutical Products R&D LLC

Status and phase

Enrolling

Phase 2

Conditions

Celiac Disease

Treatments

Drug: TEV-53408

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06807463

2024-517081-42-00 (EU Trial (CTIS) Number)

TV53408-IMM-20042

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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