Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
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
2 other identifiers
interventional
28
5 countries
6
Brief Summary
Protocol CELIM-RCD-002 is designed 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2016
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedStudy Start
First participant enrolled
April 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2017
CompletedResults Posted
Study results publicly available
December 27, 2019
CompletedDecember 27, 2019
November 1, 2019
12 months
November 28, 2015
December 11, 2019
December 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes
The primary endpoint in this study was the change form baseline in the percentage of aberrant intestinal intraepithelial lymphocytes (IELs) with respect to total IELs, as assessed by flow cytometry (Immunological Response 1). Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. In refractory coeliac disease type 2, aberrant intraepithelial lymphocytes make up 20% or more of total intraepithelial lymphocytes. Aberrant IELs were defined by flow cytometry as surface cluster of differentiation (CD)3-negative, intracellular CD3-positive IELs (sCD3-, icCD3+).
Baseline and week 12
Secondary Outcomes (8)
Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intestinal Epithelial Cells
Baseline and week 12
Percent Change From Baseline in Villous Height to Crypt Depth (VH:CD) Ratio
Baseline and week 12
Percentage of Participants With Improvement in Marsh Score at Week 12
Baseline and week 12
Percent Change From Baseline in Total Intraepithelial Lymphocyte Count at Week 12
Baseline and week 12
Number of Weekly Bowel Movements at Baseline and Week 12
Baseline and week 12
- +3 more secondary outcomes
Study Arms (2)
AMG 714
EXPERIMENTALParticipants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
Placebo
PLACEBO COMPARATORParticipants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of refractory celiac disease Type II (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
You may not qualify if:
- Enteropathy-Associated T cell Lymphoma (EATL)
- Infections
- Immune suppression
- Clinically significant co-morbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (6)
Clinical Site
San Diego, California, United States
Clinical Site
New York, New York, United States
Clinical Site
Tampere, Finland
Clinical Site
Paris, France
Clinical Site
Amsterdam, Netherlands
Clinical Site
Madrid, Spain
Related Publications (1)
Cellier C, Bouma G, van Gils T, Khater S, Malamut G, Crespo L, Collin P, Green PHR, Crowe SE, Tsuji W, Butz E, Cerf-Bensussan N, Macintyre E, Parnes JR, Leon F, Hermine O, Mulder CJ; RCD-II Study Group Investigators. Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: a phase 2a, randomised, double-blind, placebo-controlled, parallel-group study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):960-970. doi: 10.1016/S2468-1253(19)30265-1. Epub 2019 Sep 4.
PMID: 31494097DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
Amgen, MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 28, 2015
First Posted
December 17, 2015
Study Start
April 13, 2016
Primary Completion
April 11, 2017
Study Completion
May 2, 2017
Last Updated
December 27, 2019
Results First Posted
December 27, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
Publication in peer-reviewed journals