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A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Larazotide Acetate
placebo
Sponsored by
9 Meters Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring larazotide acetate

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
  • measurable serology at screening
  • CeD GSRS score of ≥ 2.0 prior to randomization
  • experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
  • willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion Criteria:

  • refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
  • chronic active GI disease other than celiac disease
  • diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
  • hemoglobin value < 8.5 g/dL

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Larazotide Acetate 0.5 mg

Larazotide Acetate 1 mg

Larazotide Acetate 2 mg

Placebo

Arm Description

larazotide acetate 0.5 mg capsules TID

larazotide acetate 1 mg capsules TID

larazotide acetate 2 mg capsules TID

placebo capsules TID

Outcomes

Primary Outcome Measures

Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).

Secondary Outcome Measures

Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
Validate a CeD PRO diary instrument in subjects with celiac disease
The CeD PRO is a 12-item questionnaire that was developed to assess symptom severity in clinical trials in subjects with celiac disease. Items in the questionnaire were formulated based on one-on-one interviews with subjects with celiac disease and thus reflect the symptoms that subjects consider part of their celiac disease experience. Subjects rated their symptom severity on an 11-point (0-10) scale. Symptoms included abdominal cramping, abdominal pain, bloating, constipation, diarrhea, gas, loose stools, nausea, vomiting, headache, and tiredness. The questionnaire was designed as a self-administered daily diary, to be completed at the same time each day, and required < 10 minutes to complete.
Compare various efficacy endpoints during 12 weeks of double-blind treatment
Additional efficacy assessments comprised a variety of known scales used for evaluating subjects with celiac disease, including the Gastrointestinal Symptoms Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), Short Form 12 health survey Version 2 (SF12v2), Celiac Disease Quality of Life (CeD-QoL) scale, and the Clinical Global Assessment (CGA). A Gluten-Free Diet Compliance Questionnaire (GFDCQ) and Celiac Dietary Adherence Test (CDAT) were also included to assess compliance with the gluten-free diet.

Full Information

First Posted
July 14, 2011
Last Updated
September 15, 2017
Sponsor
9 Meters Biopharma, Inc.
Collaborators
Teva Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT01396213
Brief Title
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
Official Title
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 7, 2011 (Actual)
Primary Completion Date
August 20, 2013 (Actual)
Study Completion Date
August 20, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
9 Meters Biopharma, Inc.
Collaborators
Teva Pharmaceuticals USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
Detailed Description
This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
larazotide acetate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Larazotide Acetate 0.5 mg
Arm Type
Experimental
Arm Description
larazotide acetate 0.5 mg capsules TID
Arm Title
Larazotide Acetate 1 mg
Arm Type
Experimental
Arm Description
larazotide acetate 1 mg capsules TID
Arm Title
Larazotide Acetate 2 mg
Arm Type
Experimental
Arm Description
larazotide acetate 2 mg capsules TID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsules TID
Intervention Type
Drug
Intervention Name(s)
Larazotide Acetate
Other Intervention Name(s)
AT-1001, INN-202
Intervention Description
gelatin capsule
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
gelatin capsule
Primary Outcome Measure Information:
Title
Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
Description
The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).
Time Frame
CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease
Description
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
Time Frame
Up to 12 weeks
Title
Validate a CeD PRO diary instrument in subjects with celiac disease
Description
The CeD PRO is a 12-item questionnaire that was developed to assess symptom severity in clinical trials in subjects with celiac disease. Items in the questionnaire were formulated based on one-on-one interviews with subjects with celiac disease and thus reflect the symptoms that subjects consider part of their celiac disease experience. Subjects rated their symptom severity on an 11-point (0-10) scale. Symptoms included abdominal cramping, abdominal pain, bloating, constipation, diarrhea, gas, loose stools, nausea, vomiting, headache, and tiredness. The questionnaire was designed as a self-administered daily diary, to be completed at the same time each day, and required < 10 minutes to complete.
Time Frame
The CeD PRO was administered daily throughout the study.
Title
Compare various efficacy endpoints during 12 weeks of double-blind treatment
Description
Additional efficacy assessments comprised a variety of known scales used for evaluating subjects with celiac disease, including the Gastrointestinal Symptoms Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), Short Form 12 health survey Version 2 (SF12v2), Celiac Disease Quality of Life (CeD-QoL) scale, and the Clinical Global Assessment (CGA). A Gluten-Free Diet Compliance Questionnaire (GFDCQ) and Celiac Dietary Adherence Test (CDAT) were also included to assess compliance with the gluten-free diet.
Time Frame
GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.

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: Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months measurable serology at screening CeD GSRS score of ≥ 2.0 prior to randomization experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache) willing to maintain current diet gluten-free diet throughout the duration of the study. Exclusion Criteria: refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.) chronic active GI disease other than celiac disease diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study hemoglobin value < 8.5 g/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Rasmussen, MD, PhD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
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
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Summerfield
State/Province
Florida
ZIP/Postal Code
34491
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
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
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
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
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
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
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73160
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
City
Perkasie
State/Province
Pennsylvania
ZIP/Postal Code
18944
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
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75321
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2X8
Country
Canada
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2T3R7
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y1Z9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2K5
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V3P9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L854J9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25683116
Citation
Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015 Jun;148(7):1311-9.e6. doi: 10.1053/j.gastro.2015.02.008. Epub 2015 Feb 13.
Results Reference
result

Learn more about this trial

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

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