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

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ClinicalTrials.gov Identifier: NCT02637141
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Protocol CELIM-NRCD-001 is designed to be a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group study 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.

Condition or disease Intervention/treatment Phase
Celiac Disease Biological: AMG 714 Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 9, 2016
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : March 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: AMG 714 150 mg
AMG 714 150 mg SC every two weeks
Biological: AMG 714
A fully human anti-IL-15 monoclonal antibody

Experimental: AMG 714 300 mg
AMG 714 300 mg SC every two weeks
Biological: AMG 714
A fully human anti-IL-15 monoclonal antibody

Placebo Comparator: Placebo
Placebo SC every two weeks
Biological: Placebo
Placebo comparator




Primary Outcome Measures :
  1. Attenuation of gluten-induced small intestinal mucosal injury as assessed by the change from baseline to Week 12 in Vh:Cd ratio [ Time Frame: Baseline and 12 weeks ]
    The Vh:Cd is the morphometric measure of the length of the small intestinal villi with respect to the depth of the crypts


Secondary Outcome Measures :
  1. Attenuation of gluten-induced small intestinal mucosal inflammation at Week 12 compared to baseline, as measured by the enumeration of intraepithelial lymphocytes (IELs) in histological sections [ Time Frame: Baseline and 12 weeks ]
    Small bowel biopsies will be processed and stained with hematoxylin-eosin stains, and the IELs counted per 100 epithelial cells.

  2. Attenuation of gluten-induced serum antibodies at Week 12 compared to baseline (anti-deamidated gliadin peptides, DGP) and autoantibodies (anti-transglutaminase, ATG) [ Time Frame: Baseline and 12 weeks ]
    DGP and ATG antibodies will be measured in serum by ELISA technique

  3. Attenuation at Week 12 compared to baseline, of gluten-induced clinical symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Baseline and 12 weeks ]
    The GSRS questionnaire will be filled at every visit (approximately monthly)


Other Outcome Measures:
  1. Safety and Tolerability of AMG 714 as assessed by the proportion of subjects with drug related adverse events [ Time Frame: 12 weeks ]
    Adverse events and serious adverse events will be captured on an on-going basis from screening to study end.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 GI disease
  • Infections, concomitant diseases
  • Prohibited medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637141


Locations
Finland
ODL
Oulu, Finland
Tampere University Hospital
Tampere, Finland
CRST
Turku, Finland
Sponsors and Collaborators
Amgen
Investigators
Study Director: Amgen, MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02637141     History of Changes
Other Study ID Numbers: CELIM-NRCD-001
2015-003647-19 ( EudraCT Number )
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in peer-reviewed journal

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Amgen:
celiac
gluten
IL-15
AMG 714

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases