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Completed

NCT Number: NCT01255696

Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

A phase 2a study to evaluate the safety and efficacy of ALV003 to treat 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

Terveystalo Kuopio, Kuopio, Finland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of biopsy-proven celiac disease
  • Adherence to a gluten-free diet
  • TG2 antibody negative
  • Signed informed consent

Exclusion criteria

  • Active dermatitis herpetiformis
  • History of IgE-mediated reactions to gluten
  • Use of specific medications 6 months prior to entry
  • History of alcohol abuse or illicit drug use
  • Current untreated or GI disease
  • Positive pregnancy test
  • Received any experimental drug within 14 days of randomization
  • Uncontrolled chronic disease or condition
  • Uncontrolled complications of celiac disease
  • Any medical condition which could adversely affect study participation

Treatment and study plan

ALV003

Biological

ALV003 placebo

Biological

Primary outcomes

  1. Efficacy: Intestinal mucosal morphology

    Time frame: 6 weeks

    Intestinal mucosal morphology - change from baseline to week 6

  2. Safety: Tolerability of ALV003

    Time frame: 6 weeks

    Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Secondary outcomes

  1. Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype

    Time frame: 6 weeks

    Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6

  2. Efficacy: Change in serological markers of celiac disease

    Time frame: 6 weeks

    Serological markers of celiac disease - change from baseline to week 6

Sponsors and collaborators

Lead sponsor

Alvine Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Aug 6, 2012

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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