Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | April 13, 2016 |
| End Date: | May 2, 2017 |
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
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.
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.
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
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