Phase 2
Completed N=64
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Source: ClinicalTrials.gov NCT02637141 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.