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

Amgen

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Other: Gluten Challenge; Other: Placebo Gluten Challenge; Biological: Placebo; Biological: AMG 714

Study type: Interventional

Funder types: Industry

Identifiers

NCT02637141

CELIM-NRCD-001

2015-003647-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 3 patient groups, including a placebo group

AMG 714 150 mg

Experimental group

Description:

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).

Treatment:

Biological: AMG 714

Other: Placebo Gluten Challenge

Other: Gluten Challenge

AMG 714 300 mg

Experimental group

Description:

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).

Treatment:

Biological: AMG 714

Other: Placebo Gluten Challenge

Other: Gluten Challenge

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo Gluten Challenge

Biological: Placebo

Other: Gluten Challenge