N/A
N=16
Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge
Celiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT03409796 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change From Baseline in Small Intestine Histology Based on Villous Height to Crypt Depth (Vh:Cd) Ratio — 2.10; 2.30; -0.06; -1.53 ratio — p=0.385
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gluten (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Small Intestine Histology Based on Villous Height to Crypt Depth (Vh:Cd) Ratio |
2.10; 2.30; -0.06; -1.53 | 0.385 |
| PRIMARY Change From Baseline in Small Intestine Histology Based on Intraepithelial Lymphocytes (IEL) Counts |
26.74; 26.68; 9.56; 26.80 | 0.010 sig |
| SECONDARY Correlation Coefficient Changes Between Gluten-specific Blood T Cells and Standard CeD Histological Assessments |
-0.0355; 0.1480; -0.0050; -0.0905; 0.0368; -0.0170 | — |
| SECONDARY Change From Baseline in Gluten-specific T Cells in Blood Based on Enzyme-linked Immune Absorbent Spot (ELISPot) Assay and T Cell Receptor (TCR) Human Leukocyte Antigen Serotype (HLA-DQ2)-Tetramers |
1.00; 1.45; 3.83; 25.12; 34.62; 17.33 | — |
Summary
The primary purpose of this study is to characterize changes in gluten-specific T cells and pathology in the small intestine with specific focus on biomarkers likely to change with therapeutic celiac disease (CeD) treatment.
Eligibility Criteria
Inclusion Criteria
- Be a non-smoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before Day 1 gluten administration.
- Have well-controlled biopsy-proven CeD, compliant with a gluten-free diet (GFD) for greater than or equal to (>=) 6 months preceding screening, with resolution of CeD symptoms, normalization of CeD serology, and in the judgment of the investigator, have inactive or minimally-active disease.
- Be HLA-DQ2.5 and/or HLA-DQ8 positive, assessed at screening. If participants have already been genotyped, results from previous testing may be used in lieu of genotyping at screening.
- Be willing to delay a planned procedure involving the use of powerful electromagnetic fields (example, magnetic resonance imaging), until the PillCam SB 3 capsule is excreted.
- Not undergo VCE or optical coherence tomography (OCT) if has an implanted electromedical device or a swallowing disorder.
- Not undergo OCT if has a contraindication to the device or procedure as per reference information.
Exclusion Criteria
- Had major surgery and/or donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 8 weeks before the first dose of gluten.
- Are unable to refrain from or anticipate the use of any unapproved medication, including prescription drugs, nonprescription drugs, and herbal remedies, beginning approximately 7 days before administration of the initial dose of gluten and continuing throughout the trial until the follow-up visit.
- Consume excessive amounts of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. An excessive amount is defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine).
- Have positive IgA anti-tissue transglutaminase (tTG), IgA anti-deamidated gliadin peptide (DGP), and IgG DGP serologies at Screening.
- Have inflammatory gastrointestinal disorders or autoimmune diseases other than CeD or autoimmune thyroid disease.
- Have known or suspected gastrointestinal obstructions, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile of the PillCam SB 3 capsule.
- Endoscopy and intestinal biopsy are contraindicated.
Data sourced from ClinicalTrials.gov (NCT03409796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.