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Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

Primary Purpose

Celiac Disease

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
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, Gluten-free diet, Coeliac disease, Celiac sprue

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18 to 80 years
  • Physician diagnosed celiac disease
  • Adherence to a gluten-free diet
  • Experiencing symptoms of celiac disease over a 1-month period
  • Willing to take study medication for 12 weeks
  • Willing to comply with all study procedures
  • Sign informed consent

Exclusion Criteria:

  • Active inflammatory bowel disease
  • Active dermatitis herpetiformis
  • Use of certain specific medications prior to entry
  • History of alcohol or illicit drug abuse in previous 6 months
  • Pregnant or lactating
  • Received any experimental drug within 30 days of enrollment
  • Uncontrolled chronic disease or condition

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALV003

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Efficacy: Intestinal mucosal morphometry
Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12

Secondary Outcome Measures

Efficacy: Intestinal intraepithelial lymphocyte density
Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
Safety: safety and tolerability of ALV003
Incidence of adverse events between baseline and week 12

Full Information

First Posted
August 2, 2013
Last Updated
December 16, 2014
Sponsor
Alvine Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01917630
Brief Title
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
Official Title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac disease, Gluten-free diet, Coeliac disease, Celiac sprue

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ALV003
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ALV003
Intervention Description
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Efficacy: Intestinal mucosal morphometry
Description
Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Efficacy: Intestinal intraepithelial lymphocyte density
Description
Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
Time Frame
12 weeks
Title
Safety: safety and tolerability of ALV003
Description
Incidence of adverse events between baseline and week 12
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Celiac disease-specific serology
Time Frame
12 weeks
Title
Quality of life
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18 to 80 years Physician diagnosed celiac disease Adherence to a gluten-free diet Experiencing symptoms of celiac disease over a 1-month period Willing to take study medication for 12 weeks Willing to comply with all study procedures Sign informed consent Exclusion Criteria: Active inflammatory bowel disease Active dermatitis herpetiformis Use of certain specific medications prior to entry History of alcohol or illicit drug abuse in previous 6 months Pregnant or lactating Received any experimental drug within 30 days of enrollment Uncontrolled chronic disease or condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Adelman, MD
Organizational Affiliation
Alvine Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
City
Decatur
State/Province
Alabama
ZIP/Postal Code
35601
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2H 7B3
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9C 4Z5
Country
Canada
City
Tampere
Country
Finland
City
Galway
Country
Ireland
City
Oslo
Country
Norway
City
Sheffield
ZIP/Postal Code
S11 7FF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28755266
Citation
Syage JA, Murray JA, Green PHR, Khosla C. Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. Dig Dis Sci. 2017 Sep;62(9):2428-2432. doi: 10.1007/s10620-017-4687-7. Epub 2017 Jul 28.
Results Reference
derived
PubMed Identifier
27864127
Citation
Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Maki M, Adelman DC; CeliAction Study Group of Investigators. No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. Gastroenterology. 2017 Mar;152(4):787-798.e2. doi: 10.1053/j.gastro.2016.11.004. Epub 2016 Nov 15.
Results Reference
derived

Learn more about this trial

Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

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