Trials / Completed
CompletedNCT02637141
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AMG 714 | AMG 714 administered by subcutaneous injection |
| BIOLOGICAL | Placebo | Matching placebo to AMG 714 administered by subcutaneous injection |
| OTHER | Placebo Gluten Challenge | Gluten-free cookies (Finnish rusks) |
| OTHER | Gluten Challenge | Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving |
Timeline
- Start date
- 2016-04-13
- Primary completion
- 2017-02-15
- Completion
- 2017-03-14
- First posted
- 2015-12-22
- Last updated
- 2019-12-03
- Results posted
- 2019-12-03
Locations
3 sites across 1 country: Finland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02637141. Inclusion in this directory is not an endorsement.