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

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637141
• Other study ID #: CELIM-NRCD-001
• Secondary ID: 2015-003647-19
• Status: Completed
• Phase: Phase 2
• Start date: April 13, 2016
• Est. completion date: March 14, 2017

Study information

• Verified date: October 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 14, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Biological:
• AMG 714
AMG 714 administered by subcutaneous injection
• Placebo
Matching placebo to AMG 714 administered by subcutaneous injection

Other:
• Placebo Gluten Challenge
Gluten-free cookies (Finnish rusks)
• Gluten Challenge
Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving

Locations

Country	Name	City	State
Finland	ODL	Oulu
Finland	Tampere University Hospital	Tampere
Finland	CRST	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12	Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes is associated with celiac 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	Number of Participants With Improvement in Marsh Score at Week 12	The Marsh classification system describes the stages of damage in the small intestine as seen under a microscope, with possible values of 0, 1, 2, 3a, 3b, or 3c. A score of 0 (best score) indicates that the intestinal lining is normal and celiac disease highly unlikely, a score of 3c (worst score) indicates increased intraepithelial lymphocytes, increased crypt hyperplasia and complete villi atrophy. Improvement is defined as a lower grade on the Marsh score scale compared to baseline.	Baseline and week 12
Secondary	Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12	Levels of anti-tTG IgA antibodies in serum were determined using an enzyme-linked immunosorbent assay (ELISA) immunoassay.	Baseline and week 12
Secondary	Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12	Levels of serum anti-DGP antibodies (immunoglobulin A [IgA] and immunoglobulin G [IgG]) were determined using ELISA immunoassay.	Baseline and week 12
Secondary	Number of Weekly Bowel Movements at Baseline and Week 12	Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced on any given day, the participant was required to document this using the electronic diary.	Baseline and week 12
Secondary	Number of Participants With Diarrhoea at Baseline and Week 12	The Bristol Stool Form Scale (BSFS) is a pictorial aid to help study participants identify the shape and consistency of their bowel movements. Participants were asked to complete this form daily using an electronic diary at the time of each bowel movement. The BSFS categorizes bowel movements into 7 types, from Type 1 (separate hard lumps, like nuts; hard to pass) to Type 7 (watery, no solid pieces, entirely liquid).; Diarrhoea was defined as at least one BSFS score >= 6 for the given week.	Baseline and week 12
Secondary	Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12	The GSRS is a 15-question 7-scale questionnaire used to assess 5 dimensions of gastrointestinal syndromes: diarrhea, indigestion, constipation, abdominal pain, and reflux. Questions are scored between 1 (no discomfort at all) and 7 (very severe discomfort). The total GSRS score is calculated as the sum of the scores of all 15 questions, and ranges from 15 (no discomfort at all) to 105 (very severe discomfort in all 5 dimensions of gastrointestinal syndromes).	Baseline and 12 weeks
Secondary	Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12	The CeD-GSRS score is derived from a subset of questions from the GSRS questionnaire, including the diarrhea, indigestion, and abdominal pain domains (a total of 10 questions), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort).; The total CeD-GSRS score is calculated as the sum of the scores of all 10 questions, and ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes).	Baseline and 12 weeks

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