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

NCT02633020 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-12-27

Study results available
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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.

Conditions

  • Type II Refractory Celiac Disease (RCD-II)
  • In-situ Small Bowel T-cell Lymphoma

Interventions

BIOLOGICAL

AMG 714

Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.

BIOLOGICAL

Placebo

Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.

Sponsors & Collaborators

Principal Investigators

  • Amgen, MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-13
Primary Completion
2017-04-11
Completion
2017-05-02
FDA Drug
Yes

Countries

  • United States
  • Finland
  • France
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633020 on ClinicalTrials.gov