A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Celiac Disease
- Sponsor
- Amgen
- Enrollment
- 64
- Locations
- 3
- Primary Endpoint
- Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening
- •On a gluten-free diet for at least 12 months
- •Negative celiac serology
- •Avoidance of pregnancy
Exclusion Criteria
- •Severe complications of celiac disease, such as refractory celiac disease
- •Celiac symptoms
- •Other concomitant autoimmune disease
- •Chronic, active gastrointestinal disease
- •Infections, concomitant diseases
- •Prohibited medications
Outcomes
Primary Outcomes
Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12
Time Frame: Baseline and week 12
Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.
Secondary Outcomes
- Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12(Baseline and week 12)
- Number of Participants With Improvement in Marsh Score at Week 12(Baseline and week 12)
- Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12(Baseline and week 12)
- Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12(Baseline and week 12)
- Number of Weekly Bowel Movements at Baseline and Week 12(Baseline and week 12)
- Number of Participants With Diarrhoea at Baseline and Week 12(Baseline and week 12)
- Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12(Baseline and 12 weeks)
- Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12(Baseline and 12 weeks)