MedTrace Logo

A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

NCT02637141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-12-03

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

Principal Investigators

  • Amgen, MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-13
Primary Completion
2017-02-15
Completion
2017-03-14
FDA Drug
Yes

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637141 on ClinicalTrials.gov