TEV-53408 for Celiac Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

Adults with celiac disease who have been diagnosed for at least a year and on a gluten-free diet for the same duration. Women can't be pregnant or planning pregnancy, and men must use condoms if their partners are of child-bearing potential.

Inclusion Criteria

I was diagnosed with celiac disease over a year ago.

I have been on a gluten-free diet for at least 12 months.

I understand there may be more criteria to meet.

+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TEV-53408 or placebo while undergoing oral gluten exposure to assess efficacy and safety

8 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants continue to be monitored for long-term safety and efficacy outcomes

74 weeks

Participant Groups

The trial is testing TEV-53408's effectiveness in reducing gluten-induced damage in adults with celiac disease compared to a placebo. Participants will be monitored over approximately 86 weeks to assess both efficacy and safety.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TEV-53408Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention