๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-25

A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease (NCT06807463)

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Teva Branded Pharmaceutical Products R&D LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 can join: Review the eligibility criteria below.

Location: Teva Investigational Site 12138 โ€” Murrieta, California

Age range: 18 Years to 64 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (21 Sites)

  • Teva Investigational Site 12138 โ€” Murrieta, California
  • Teva Investigational Site 12131 โ€” Colorado Springs, Colorado
  • Teva Investigational Site 12134 โ€” Inverness, Florida
  • Teva Investigational Site 12126 โ€” Miami Lakes, Florida
  • Teva Investigational Site 12135 โ€” New Port Richey, Florida
  • Teva Investigational Site 12130 โ€” Atlanta, Georgia
  • Teva Investigational Site 12133 โ€” Marrero, Louisiana
  • Teva Investigational Site 12132 โ€” Clinton Township, Michigan
  • Teva Investigational Site 12121 โ€” Wyoming, Michigan
  • Teva Investigational Site 12129 โ€” Rochester, Minnesota
  • Teva Investigational Site 12128 โ€” New York, New York
  • Teva Investigational Site 12125 โ€” Greenville, North Carolina
  • Teva Investigational Site 12127 โ€” Winston-Salem, North Carolina
  • Teva Investigational Site 12137 โ€” Waco, Texas
  • Teva Investigational Site 12122 โ€” Ogden, Utah
  • Teva Investigational Site 12123 โ€” Lynchburg, Virginia
  • Teva Investigational Site 78139 โ€” Fitzroy,
  • Teva Investigational Site 78140 โ€” Maroochydore,
  • Teva Investigational Site 78137 โ€” Midland,
  • Teva Investigational Site 40063 โ€” Helsinki,
  • Teva Investigational Site 40062 โ€” Tampere,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Celiac Disease clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—