A Study of the Safety, Pharmacodynamics, Effectiveness, and PK of TIMP-GLIA in Subjects with Celiac Disease


About this study

The purpose of this study is to evaluate participants for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.

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:

  • Male or nonpregnant female.
  • 18 to 70 years old, inclusive, at Screening Visit.
  • Biopsy-confirmed CD (intestinal histology showing villous atrophy).
  • Positive for human leukocyte antigen (HLA)-DQ2 or HLA-DQ2/DQ8 - results will be obtained at Screening if unknown or results are not available. 
  • Self-reported to be on a GFD for at least 6 months prior to Screening and agree to continue GFD throughout study, with the exception of the oral gluten challenge. 
  • Normal or negative celiac serology, at screening, defined as: 1. Measurable total
  • serum immunoglobulin A (IgA) AND 2. Negative or weak positive tissue transglutaminase (tTG) IgA titer OR 3. If IgA deficient, defined by a serum IgA level of < 3 mg/dL, negative or weak positive DGP- IgG titer.
  • Vh:Cd ≥ 1.5 on screening biopsy.

 Exclusion Criteria:

  • Positive for only HLA-DQ8.
  • History of clinically confirmed immunoglobulin E (IgE)-mediated reaction and/or anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye.
  • Uncontrolled CD and/or active signs/symptoms of CD, in the opinion of the investigator.
  • Untreated or active gastrointestinal disease such as peptic ulcer disease, esophagitis (Los Angeles Classification ≥ Grade C), irritable bowel syndrome, inflammatory bowel disease, or microscopic colitis. 
  • Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior Dose 1, any dose of corticosteroids within 30 days of Day 1, or high dose inhaled corticosteroids [> 960 µg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
  • Presence or history of celiac-associated thyroid disease or Type 1 diabetes, regardless of current treatment.

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

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Closed for enrollment

More information


Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions