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

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
ALV003
ALV003 placebo
Sponsored by
Alvine Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Celiac Disease, Coeliac Disease, Celiac Sprue, Keliakia Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Terveystalo Kuopio
  • Oulu Diakonissalaitos (ODL)
  • FINN-MEDI Research Oy - Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALV003

Placebo

Arm Description

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.

Excipients for ALV003 absent the experimental compounds

Outcomes

Primary Outcome Measures

Efficacy: Intestinal mucosal morphology
Intestinal mucosal morphology - change from baseline to week 6
Safety: Tolerability of ALV003
Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Secondary Outcome Measures

Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6
Efficacy: Change in serological markers of celiac disease
Serological markers of celiac disease - change from baseline to week 6

Full Information

First Posted
December 3, 2010
Last Updated
July 30, 2012
Sponsor
Alvine Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01255696
Brief Title
Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alvine Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac Disease, Coeliac Disease, Celiac Sprue, Keliakia Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALV003
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Excipients for ALV003 absent the experimental compounds
Intervention Type
Biological
Intervention Name(s)
ALV003
Intervention Type
Biological
Intervention Name(s)
ALV003 placebo
Primary Outcome Measure Information:
Title
Efficacy: Intestinal mucosal morphology
Description
Intestinal mucosal morphology - change from baseline to week 6
Time Frame
6 weeks
Title
Safety: Tolerability of ALV003
Description
Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
Description
Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6
Time Frame
6 weeks
Title
Efficacy: Change in serological markers of celiac disease
Description
Serological markers of celiac disease - change from baseline to week 6
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marja-Leena Lähdeaho, MD
Organizational Affiliation
FINN-MEDI Research Oy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markku Mäki, MD, PhD
Organizational Affiliation
Tampere University
Official's Role
Study Chair
Facility Information:
Facility Name
Terveystalo Kuopio
City
Kuopio
Country
Finland
Facility Name
Oulu Diakonissalaitos (ODL)
City
Oulu
Country
Finland
Facility Name
FINN-MEDI Research Oy - Clinical Trials Center
City
Tampere
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24583059
Citation
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.
Results Reference
derived

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

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