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Trial record 1 of 1 for:    NCT02637141
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A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celimmune
ClinicalTrials.gov Identifier:
NCT02637141
First received: November 28, 2015
Last updated: August 6, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Celiac Disease Biological: AMG 714 Biological: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Celimmune:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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

  • 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:
  • 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.


Enrollment: 64
Study Start Date: March 30, 2016
Estimated Study Completion Date: October 2017
Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02637141

Locations
Finland
ODL
Oulu, Finland
Tampere University Hospital
Tampere, Finland
CRST
Turku, Finland
Sponsors and Collaborators
Celimmune
Investigators
Study Chair: Markku Maki, MD PhD Tampere University
  More Information

Additional Information:
Responsible Party: Celimmune
ClinicalTrials.gov Identifier: NCT02637141     History of Changes
Other Study ID Numbers: CELIM-NRCD-001
2015-003647-19 ( EudraCT Number )
Study First Received: November 28, 2015
Last Updated: August 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in peer-reviewed journal

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

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

ClinicalTrials.gov processed this record on September 21, 2017