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

NCT01255696 | Completed Phase 2

• 2 other identifiers: ALV003-10212010-023127-23
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Celiac Disease

Keywords

Celiac Disease; Coeliac Disease; Celiac Sprue; Keliakia Disease

Outcome Measures

Primary Outcomes (2)

• Efficacy: Intestinal mucosal morphology

  Intestinal mucosal morphology - change from baseline to week 6

  6 weeks

• Safety: Tolerability of ALV003

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

  6 weeks

Secondary Outcomes (2)

• Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype

  6 weeks

• Efficacy: Change in serological markers of celiac disease

  6 weeks

Study Arms (2)

ALV003

EXPERIMENTAL

ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten.

Biological: ALV003

Placebo

PLACEBO COMPARATOR

Excipients for ALV003 absent the experimental compounds

Biological: ALV003 placebo

Interventions

ALV003 BIOLOGICAL

ALV003

ALV003 placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alvine Pharmaceuticals Inc.: lead

Study Sites (3)

Terveystalo Kuopio

Kuopio, Finland

Location

Oulu Diakonissalaitos (ODL)

Oulu, Finland

Location

FINN-MEDI Research Oy - Clinical Trials Center

Tampere, Finland

Location

Related Publications (1)

• Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25.

  PMID: 24583059 DERIVED

MeSH Terms

Conditions

Celiac Disease

Interventions

ALV003

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marja-Leena Lähdeaho, MD

  FINN-MEDI Research Oy

  PRINCIPAL INVESTIGATOR

• Markku Mäki, MD, PhD

  Tampere University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 6, 2012

Record last verified: 2012-07

Locations

FI (3)