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

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ClinicalTrials.gov Identifier: NCT02633020
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Protocol CELIM-RCD-002 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 treatment of adult patients with Type II Refractory Celiac Disease (RCD-II), an in situ small bowel T cell lymphoma.

Condition or disease Intervention/treatment Phase
Type II Refractory Celiac Disease (RCD-II) In Situ Small Bowel T Cell Lymphoma Biological: AMG 714 Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 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 Type II Refractory Celiac Disease, an In Situ Small Bowel T Cell Lymphoma
Actual Study Start Date : April 13, 2016
Actual Primary Completion Date : April 11, 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AMG 714 8 mg/kg
AMG 714 IV every two weeks
Biological: AMG 714
A fully human anti-IL-15 monoclonal antibody

Placebo Comparator: Placebo
Placebo IV every two weeks
Biological: Placebo



Primary Outcome Measures :
  1. Immunological Response: Reduction from baseline in the % of aberrant small bowel intestinal intraepithelial lymphocytes (surface CD3- intracellular CD3+) [ Time Frame: Baseline and 12 weeks ]
    Reduction from baseline in the % of aberrant intestinal intraepithelial lymphocytes, measured by flow cytometry after small intestinal biopsy collection


Secondary Outcome Measures :
  1. Histological Response: Improvement from baseline in small intestinal morphology as measured by the Vh:Cd ratio [ Time Frame: Baseline and 12 weeks ]
    The Villous Height to Crypt Depth ratio (Vh:Cd) will be used in intestinal biopsy material

  2. Clinical response: Change from baseline in clinical symptoms as measured by the GSRS [ Time Frame: Baseline and 12 weeks ]
    The main secondary patient reported outcome used will be the GSRS (Gastrointestinal Symptom Rating Scale).


Other Outcome Measures:
  1. Safety and Tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE [ Time Frame: 12 weeks ]
    The frequency and nature of adverse events will be collected and analyzed



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Confirmed diagnosis of refractory celiac disease Type 2 (RCD-II)
  • Greater than 20% aberrant intraepithelial lymphocytes (IEL) as assessed by flow cytometry
  • On a gluten-free diet for at least 6 months
  • Avoid pregnancy

Exclusion Criteria:

  • Enteropathy-Associated T cell Lymphoma (EATL)
  • Infections
  • Immune suppression
  • Clinically significant co-morbidities

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): NCT02633020


Locations
United States, California
Clinical Site
San Diego, California, United States
United States, New York
Clinical Site
New York, New York, United States
Finland
Clinical Site
Tampere, Finland
France
Clinical Site
Paris, France
Netherlands
Clinical Site
Amsterdam, Netherlands
Spain
Clinical Site
Madrid, Spain
Sponsors and Collaborators
Amgen
Investigators
Study Director: Amgen, MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02633020     History of Changes
Other Study ID Numbers: CELIM-RCD-002
2015-004063-36 ( EudraCT Number )
First Posted: December 17, 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 journals

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Celiac Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases