A Trial To Assess The Efficacy And Safety Of TEV-53408 In Adults With Celiac Disease

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Contact us for the latest status

Contact information:

Chadrick Hinson

(507) 266-0237

Hinson.Chadrick@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20591252

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