Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Intervention: TIMP-GLIA; Placebo
Intervention description: 8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8.; Administered intravenously on days 1 and 8.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Subjects enrolled in this study will be evaluated 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.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or nonpregnant female, ages 18 to 70 years inclusive, at Screening Visit.

          2. Biopsy-confirmed CD (intestinal histology showing villous atrophy).

          3. Positive for human leukocyte antigen (HLA)-DQ2 or HLA-DQ2/DQ8 - results will be
             obtained at Screening if unknown or results are not available.

          4. 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.

             6. Vh:Cd ≥ 1.5 on screening biopsy.

             Key Exclusion Criteria:

               1. Positive for only HLA-DQ8.

               2. History of clinically confirmed immunoglobulin E (IgE)-mediated reaction and/or
                  anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye.

               3. Uncontrolled CD and/or active signs/symptoms of CD, in the opinion of the
                  investigator.

               4. 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.

               5. 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.

               6. Presence or history of celiac-associated thyroid disease or Type 1 diabetes,
                  regardless of current treatment.