CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
AMG 714 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02637141
NCT02637141Phase 2Completed

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

Amgen·interventional·Posted Dec 22, 2015·Updated Dec 3, 2019

In Brief

A Phase 2 clinical trial evaluating AMG 714, Placebo, and 2 other interventions for Celiac Disease. Completed, enrolled 64 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease
CountriesFinland
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartApr 13, 2016
Primary CompletionFeb 15, 2017
Study CompletionMar 14, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.5 years ago

Interventions

AMG 714biological

AMG 714 administered by subcutaneous injection

Placebobiological

Matching placebo to AMG 714 administered by subcutaneous injection

Placebo Gluten Challengeother

Gluten-free cookies (Finnish rusks)

Gluten Challengeother

Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving