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Trial record 8 of 32 for:    Open Studies | "Malabsorption Syndromes" | United States

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Celimmune
Information provided by (Responsible Party):
Celimmune Identifier:
First received: November 28, 2015
Last updated: April 18, 2016
Last verified: April 2016
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    The frequency and nature of adverse events will be collected and analyzed

Estimated Enrollment: 24
Study Start Date: March 2016
Estimated Primary Completion Date: June 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT02633020

Contact: Francisco Leon, MD PhD

United States, California
Clinical Site Not yet recruiting
San Diego, California, United States
United States, New York
Clinical Site Recruiting
New York, New York, United States
Contact: Peter Green, MD         
Clinical Site Recruiting
Tampere, Finland
Contact: Satu Jarvinen, MD         
Clinical Site Not yet recruiting
Paris, France
Clinical Site Recruiting
Amsterdam, Netherlands
Contact: Gerd Bouma, MD         
Clinical Site Not yet recruiting
Madrid, Spain
Sponsors and Collaborators
Study Chair: Christophe Cellier, MD PhD Hôpital Européen Georges Pompidou
Study Chair: Chris Mulder, MD PhD VUmc Amsterdam
  More Information

Additional Information:
Responsible Party: Celimmune Identifier: NCT02633020     History of Changes
Other Study ID Numbers: CELIM-RCD-002  2015-004063-36 
Study First Received: November 28, 2015
Last Updated: April 18, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
European Union: European Medicines Agency
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Publication in peer-reviewed journals

Additional relevant MeSH terms:
Malabsorption Syndromes
Lymphoma, T-Cell
Celiac Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases processed this record on October 21, 2016