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

NCT ID: NCT02633020

Last Updated: 2019-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-13

Study Completion Date

2017-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 714

Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.

Group Type EXPERIMENTAL

AMG 714

Intervention Type BIOLOGICAL

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

Placebo

Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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AMG 714

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amgen, MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Clinical Site

San Diego, California, United States

Site Status

Clinical Site

New York, New York, United States

Site Status

Clinical Site

Tampere, , Finland

Site Status

Clinical Site

Paris, , France

Site Status

Clinical Site

Amsterdam, , Netherlands

Site Status

Clinical Site

Madrid, , Spain

Site Status

Countries

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United States Finland France Netherlands Spain

References

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Cellier C, Bouma G, van Gils T, Khater S, Malamut G, Crespo L, Collin P, Green PHR, Crowe SE, Tsuji W, Butz E, Cerf-Bensussan N, Macintyre E, Parnes JR, Leon F, Hermine O, Mulder CJ; RCD-II Study Group Investigators. Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: a phase 2a, randomised, double-blind, placebo-controlled, parallel-group study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):960-970. doi: 10.1016/S2468-1253(19)30265-1. Epub 2019 Sep 4.

Reference Type DERIVED
PMID: 31494097 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.celimmune.com

Related Info

Other Identifiers

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2015-004063-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CELIM-RCD-002

Identifier Type: -

Identifier Source: org_study_id