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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-13

Study Completion Date

2017-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 714 150 mg

Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).

Group Type EXPERIMENTAL

AMG 714

Intervention Type BIOLOGICAL

AMG 714 administered by subcutaneous injection

Placebo Gluten Challenge

Intervention Type OTHER

Gluten-free cookies (Finnish rusks)

Gluten Challenge

Intervention Type OTHER

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

AMG 714 300 mg

Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).

Group Type EXPERIMENTAL

AMG 714

Intervention Type BIOLOGICAL

AMG 714 administered by subcutaneous injection

Placebo Gluten Challenge

Intervention Type OTHER

Gluten-free cookies (Finnish rusks)

Gluten Challenge

Intervention Type OTHER

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

Placebo

Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Matching placebo to AMG 714 administered by subcutaneous injection

Placebo Gluten Challenge

Intervention Type OTHER

Gluten-free cookies (Finnish rusks)

Gluten Challenge

Intervention Type OTHER

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

Interventions

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AMG 714

AMG 714 administered by subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Matching placebo to AMG 714 administered by subcutaneous injection

Intervention Type BIOLOGICAL

Placebo Gluten Challenge

Gluten-free cookies (Finnish rusks)

Intervention Type OTHER

Gluten Challenge

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

Intervention Type OTHER

Other Intervention Names

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PRV-015

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No