A Phase II Study of CCX282-B in Patients With Celiac Disease

NCT ID: NCT00540657

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to determine whether CCX282-B is effective in mitigating the effects of gluten ingestion in patients with celiac disease

Detailed Description

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Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

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Celiac Disease

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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1

Group Type EXPERIMENTAL

CCX282-B

Intervention Type DRUG

250mg capsule, twice daily, 13 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule, twice daily, 13 weeks

Interventions

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CCX282-B

250mg capsule, twice daily, 13 weeks

Intervention Type DRUG

Placebo

Placebo capsule, twice daily, 13 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, between 18 and 75 years of age
* Established diagnosis of celiac disease
* Subject has been following a strict gluten-free diet for at least 24 months

Exclusion Criteria

* History of any infection requiring intravenous antibiotics, a serious local infection, systemic infection, or gastrointestinal infection within 12 weeks of randomization
* Use of any immunosuppressants, TNF inhibitors, or natalizumab during the 12 weeks prior to study randomization
* Use of steroids during the 4 weeks prior to study randomization
* Receipt of an experimental treatment for any disease within 4 weeks prior to randomization
* Known IgE-mediated atopy or allergy or anaphylactic reactions to gluten
* The subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Finn-Medi Research Ltd, Outpatient Clinic

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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CL009_282

Identifier Type: -

Identifier Source: org_study_id

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