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Completed

NCT Number: NCT00540657

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

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

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Finn-Medi Research Ltd, Outpatient Clinic

Tampere, FIN-33520, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCX282-B

Drug

250mg capsule, twice daily, 13 weeks

Placebo

Drug

Placebo capsule, twice daily, 13 weeks

Primary outcomes

  1. 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

  1. Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure

  2. Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 8, 2007
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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