TEV-53408 for Celiac Disease

Recruiting at 11 trial locations

Overseen By Teva U.S. Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Antibiotics, Antivirals, Antifungals

Disqualifiers: Refractory celiac, Malignancy, Alcohol abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

48 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TEV-53408

Trial Overview 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.

How Is the Trial Designed?

Group I: TEV-53408 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Teva Branded Pharmaceutical Products R&D LLC

Lead Sponsor