A Phase II Study of CCX282-B in Patients With Celiac Disease | NCT00540657

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

NCT00540657

Sponsor

Amgen

Status

Completed

Last Update Posted

Mar 6, 2025Actual

Enrollment

90Estimated

Phase

Phase 2

Conditions

Celiac Disease

Interventions

CCX282-B
Placebo

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Oct 5, 2007

First Submission Date that Met QC Criteria

Oct 5, 2007

First Posted Date

Oct 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2025

Last Update Posted Date

Mar 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: CCX282-B
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CCX282-B	Drug	250mg capsule, twice daily, 13 weeks	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key 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

Key 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MD	Amgen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Finn-Medi Research Ltd, Outpatient Clinic		Tampere		FIN-33520	Finland

Condition Browse Module

MeSH Terms

ID	Term
D002446	Celiac Disease

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C583420	CCX282-B

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided