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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type II Refractory Celiac Disease (RCD-II), In-situ Small Bowel T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT02633020

Run by

Amgen

People needed

28

Starts

2016-04-13

Expected to finish

2017-05-02

Last updated by the study team

2019-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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