Phase 2
N=64
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Celiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT02637141 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 — -62.66; -53.78; -60.17 percent change — p=0.7271
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMG 714 (Biological); Placebo (Biological); Placebo Gluten Challenge (Other); Gluten Challenge (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 |
-62.66; -53.78; -60.17 | 0.7271 |
| SECONDARY Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 |
95.14; 68.22; 109.46 | 0.4746 |
| SECONDARY Number of Participants With Improvement in Marsh Score at Week 12 |
0; 0; 0 | — |
| SECONDARY Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12 |
5019.77; 1562.42; 617.53 | 0.0140 sig |
| SECONDARY Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12 |
43.19; 18.47; 25.38; 28.29; 17.98; 15.12 | 0.3034 |
| SECONDARY Number of Weekly Bowel Movements at Baseline and Week 12 |
8.9; 10.2; 9.6; 9.3; 11.5; 11.6 | 0.1610 |
| SECONDARY Number of Participants With Diarrhoea at Baseline and Week 12 |
4; 9; 7; 1; 5; 6 | — |
| SECONDARY Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12 |
4.14; 14.96; 17.58 | 0.2761 |
| SECONDARY Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12 |
0.65; 1.77; 3.41 | 0.1908 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02637141). 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.