Clinical trial NCT02633020: Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Refractory Celiac Disease (RCD-II)
In-situ Small Bowel T-cell Lymphoma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intestinal Epithelial Cells
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Villous Height to Crypt Depth (VH:CD) Ratio
timeFrame: Baseline and week 12
measure: Percentage of Participants With Improvement in Marsh Score at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Total Intraepithelial Lymphocyte Count at Week 12
timeFrame: Baseline and week 12
measure: Number of Weekly Bowel Movements at Baseline and Week 12
timeFrame: Baseline and week 12
measure: Percentage of Participants With Diarrhea at Baseline and Week 12
timeFrame: Baseline and week 12
measure: Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12
timeFrame: Baseline and week 12
measure: Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Site
state: California
city: New York
country: United States
facility: Clinical Site
state: New York
city: Tampere
country: Finland
facility: Clinical Site
city: Paris
country: France
facility: Clinical Site
city: Amsterdam
country: Netherlands
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
Study officials:
affiliation: Amgen
name: Amgen, MD
role: STUDY_DIRECTOR
References:
citation: 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.