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NCT02633020 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
28
Enrollment target

NCT02633020: Completed Phase 2 study, sponsored by Amgen.

NCT02633020 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02633020, a Phase 2 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study 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.

Primary Outcome

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. I

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL AMG 714

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2016-04-13
Est. Completion 2017-05-02
Phase Phase 2
Amgen

558 total trials

What the finished NCT02633020 record still lists

NCT02633020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02633020 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02633020 about?

NCT02633020 is a clinical study titled "Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease". 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.

What is the current status of trial NCT02633020?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2016-04-13. Estimated completion is 2017-05-02.

What interventions are being tested in trial NCT02633020?

The interventions under investigation include: Placebo (BIOLOGICAL), AMG 714 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02633020?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02633020's enrollment target sits among peer trials

28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02633020, the US trial registry maintained by the National Library of Medicine. NCT02633020 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.