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

NCT02637141 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CELIM-NRCD-0012015-003647-19
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief 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

Celiac Disease

Keywords

celiac; gluten; Interleukin 15 (IL-15); AMG 714; gluten challenge

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12

  Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.

  Baseline and week 12

Secondary Outcomes (8)

• Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12

  Baseline and week 12

• Number of Participants With Improvement in Marsh Score at Week 12

  Baseline and week 12

• Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12

  Baseline and week 12

• Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12

  Baseline and week 12

• Number of Weekly Bowel Movements at Baseline and Week 12

  Baseline and week 12

Study Arms (3)

AMG 714 150 mg

EXPERIMENTAL

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).

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

AMG 714 300 mg

EXPERIMENTAL

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).

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

Placebo

PLACEBO COMPARATOR

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).

Biological: Placebo; Other: Placebo Gluten Challenge; Other: Gluten Challenge

Interventions

AMG 714 BIOLOGICAL

AMG 714 administered by subcutaneous injection

Also known as: PRV-015

AMG 714 150 mg; AMG 714 300 mg

Placebo BIOLOGICAL

Matching placebo to AMG 714 administered by subcutaneous injection

Placebo

Placebo Gluten Challenge OTHER

Gluten-free cookies (Finnish rusks)

AMG 714 150 mg; AMG 714 300 mg; Placebo

Gluten Challenge OTHER

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

AMG 714 150 mg; AMG 714 300 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

ODL

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

CRST

Turku, Finland

Location

Related Publications (1)

• Lahdeaho ML, Scheinin M, Vuotikka P, Taavela J, Popp A, Laukkarinen J, Koffert J, Koivurova OP, Pesu M, Kivela L, Lovro Z, Keisala J, Isola J, Parnes JR, Leon F, Maki M. Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):948-959. doi: 10.1016/S2468-1253(19)30264-X. Epub 2019 Sep 4.

  PMID: 31494096 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Celiac Disease

Interventions

AMG-714

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• Amgen, MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2015
• First Posted: December 22, 2015
• Study Start: April 13, 2016
• Primary Completion: February 15, 2017
• Study Completion: March 14, 2017
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

FI (3)