This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    NCT02633020
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celimmune
ClinicalTrials.gov Identifier:
NCT02633020
First received: November 28, 2015
Last updated: August 6, 2017
Last verified: August 2017
  Purpose
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 Intervention 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
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 Type II Refractory Celiac Disease, an In Situ Small Bowel T Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Celimmune:

Primary Outcome Measures:
  • 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:
  • 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

  • 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:
  • 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


Estimated Enrollment: 24
Study Start Date: March 30, 2016
Estimated Study Completion Date: October 2017
Primary Completion Date: July 21, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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: 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
Celimmune
Investigators
Study Chair: Christophe Cellier, MD PhD Hôpital Européen Georges-Pompidou
Study Chair: Chris Mulder, MD PhD VU University Medical Center
  More Information

Additional Information:
Responsible Party: Celimmune
ClinicalTrials.gov Identifier: NCT02633020     History of Changes
Other Study ID Numbers: CELIM-RCD-002
2015-004063-36 ( 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 journals

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

ClinicalTrials.gov processed this record on September 21, 2017