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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type II Refractory Celiac Disease (RCD-II)
- Sponsor
- Amgen
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes
Time Frame: Baseline and week 12
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+).
Secondary Outcomes
- 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)
- Percentage of Participants With Diarrhea at Baseline and Week 12(Baseline and week 12)
- Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12(Baseline and week 12)
- Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12(Baseline and week 12)