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

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540657

Enrollment

Registered

2007-10-08

Start date

2007-10-31

Completion date

2008-07-31

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

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.

Interventions

DRUGCCX282-B

250mg capsule, twice daily, 13 weeks

DRUGPlacebo

Placebo capsule, twice daily, 13 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	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

Measure	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	—
Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026