Celiac DiseasePhase 3NCT03569007

Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

A Phase 3 study testing Larazotide in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 160 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Celiac Disease
What is being tested?: Larazotide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 307 participants
Where: 160 sitesUnited States
Study dates: 29 May 2019to 21 Jul 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months
On a gluten-free diet for at least 6 months
Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
Willing to maintain current gluten-free diet throughout participation in the study

Who cannot join

Refractory celiac disease or severe complications of celiac disease
Chronic active GI disease other than celiac disease

Trial locations and contacts

160 sites in 1 country.

City, postcode or hospital

160 sites in 1 country

United States160 sites

Research Site
Albuquerque, New Mexico, 87102
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Annapolis, Maryland, 21401
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Arlington Heights, Illinois, 60005
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Asheville, North Carolina, 28801
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Atlanta, Georgia, 30328
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Austin, Texas, 77024
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Austin, Texas, 78704
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Austin, Texas, 78726
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Austin, Texas, 78745
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Austin, Texas, 78757
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Baltimore, Maryland, 21208
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Bellevue, Washington, 98004
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Bellevue, Washington, 98007
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Bellflower, California, 90706
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Beverly Hills, California, 90211
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Boise, Idaho, 83706
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Boston, Massachusetts, 02114
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Boynton Beach, Florida, 33472
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Bridgeport, Connecticut, 06606
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Bristol, Connecticut, 06010
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Canoga Park, California, 91303
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Catonsville, Maryland, 21228
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Charlotte, North Carolina, 28207
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Chattanooga, Tennessee, 37421
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Chesapeake, Virginia, 23320
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Chesterfield, Michigan, 48047
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Cincinnati, Ohio, 45215
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Cincinnati, Ohio, 45219
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44122
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Clive, Iowa, 50325
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Columbia, Maryland, 21045
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Columbus, Georgia, 31904
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Columbus, Ohio, 04323
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Columbus, Ohio, 43214
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Concord, North Carolina, 28025
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Corona, California, 92879
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Crowley, Louisiana, 70526
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Cypress, Texas, 77429
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Dallas, Texas, 75224
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Dayton, Ohio, 45415
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Dayton, Ohio, 45419
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DeSoto, Texas, 75115
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Fairfax, Virginia, 22031
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Fairview Heights, Illinois, 62208
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Fall River, Massachusetts, 02723
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Freehold, New Jersey, 07728
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Gainesville, Virginia, 20155
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Garden Grove, California, 92845
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Garland, Texas, 75044
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Great Neck, New York, 11023
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Greenville, North Carolina, 27834
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Hagerstown, Maryland, 21742
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Hamden, Connecticut, 06518
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Happy Valley, Oregon, 97086
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Harlingen, Texas, 78550
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Hershey, Pennsylvania, 17033
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Houston, Texas, 77025
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Houston, Texas, 77058
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Houston, Texas, 77084
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Idaho Falls, Idaho, 83404
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Inverness, Florida, 34452
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Iowa City, Iowa, 52242
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Jackson, Minnesota, 39216
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Jefferson City, Missouri, 65109
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Lafayette, Louisiana, 70503
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Lakewood Rch, Florida, 34211
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Lancaster, California, 93534
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Lansdowne Town Center, Virginia, 20176
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Las Vegas, Nevada, 89106
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Las Vegas, Nevada, 89109
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Las Vegas, Nevada, 89119
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Las Vegas, Nevada, 89128
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Lexington, Kentucky, 40509
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Lexington, Kentucky, 40536
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Lincoln, Rhode Island, 02865
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Los Gatos, California, 95032
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Louisville, Kentucky, 40202
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Lynchburg, Virginia, 24502
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Macon, Georgia, 31201
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Maplewood, Minnesota, 55117
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Marrero, Louisiana, 70072
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McAllen, Texas, 78503
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Medford, Oregon, 97504
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Melrose Park, Illinois, 60160
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Mentor, Ohio, 44060
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Metairie, Louisiana, 70006
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Miami, Florida, 33133
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Mineola, New York, 11501
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Morton, Illinois, 61550
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Mt. Pleasant, South Carolina, 29464
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Nashville, Tennessee, 37212
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New Orleans, Louisiana, 70115
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New Orleans, Louisiana, 70125
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New Windsor, New York, 12553
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New York, New York, 10016
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New York, New York, 10032
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New York, New York, 11419
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Norfolk, Virginia, 23507
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Norman, Oklahoma, 73071
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North Little Rock, Arkansas, 72117
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Northridge, California, 91324
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Ocean Township, New Jersey, 07712
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Ogden, Utah, 84403
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Ogden, Utah, 84405
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Oklahoma City, Oklahoma, 73112
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Omaha, Nebraska, 68114
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Omaha, Nebraska, 68134
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Orange Park, Florida, 32073
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Orlando, Florida, 32803
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Orlando, Florida, 32825
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Petal, Mississippi, 39465
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Philadelphia, Pennsylvania, 19107
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Poland, Ohio, 44514
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Port Orange, Florida, 32127
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Portsmouth, New Hampshire, 03801
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Poughkeepsie, New York, 12601
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Poway, California, 92064
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Reno, Nevada, 89511
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Rialto, California, 92377
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Rochester, Michigan, 48307
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Rochester, Minnesota, 55905
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Salisbury, North Carolina, 28144
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Salt Lake City, Utah, 84124
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San Antonio, Texas, 78215
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San Antonio, Texas, 78229
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San Diego, California, 92013
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San Diego, California, 92103
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San Francisco, California, 94102
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Sandy City, Utah, 84092
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Saraland, Alabama, 36571
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Sayre, Pennsylvania, 18840
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Scottsdale, Arizona, 85251
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Scranton, Pennsylvania, 18508
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Sioux Falls, South Dakota, 57108
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Spokane, Washington, 99202
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Spokane, Washington, 99204
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St Louis, Missouri, 63141
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St. George, Utah, 84790
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Stamford, Connecticut, 06905
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Stockbridge, Georgia, 30281
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Stone Mountain, Georgia, 30083
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Sugar Hill, Georgia, 30518
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Sugar Land, Texas, 77476
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Sugar Land, Texas, 77479
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Tacoma, Washington, 98405
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Topeka, Kansas, 66606
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Tucson, Arizona, 85712
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Tucson, Arizona, 85745
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Tulsa, Oklahoma, 74104
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Vancouver, Washington, 98664
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Victoria, Texas, 77904
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Walnut Creek, California, 94598
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Warwick, Rhode Island, 02886
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Wauwatosa, Wisconsin, 53226
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West Columbia, South Carolina, 29169
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West Des Moines, Iowa, 50266
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Williamsville, New York, 14221
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Winston-Salem, North Carolina, 27103
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Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Read the detailed description

This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Conditions: Celiac Disease
Being tested: Larazotide, Matching Placebo
Medical subject headings: Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LarazotideDrug
Also called INN-202
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Matching PlaceboDrug
Also called placebo
enteric-coated beads in gelatin capsules

Study groups in NCT03569007
Study group	Role	What they receive
Larazotide 0.25 mg	Active comparator	Larazotide 0.25 mg capsules TID Receives: Drug: Larazotide
Larazotide 0.50 mg	Active comparator	Larazotide 0.50 mg capsules TID Receives: Drug: Larazotide
Placebo	Placebo comparator	Matching placebo capsules TID Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects who are binary responders
Reduction in CeD PRO Abdominal Domain scores
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 201921 Jul 2022

First posted26 Jun 2018
Study start29 May 2019
Primary completion21 Jul 2022
Study completion21 Jul 2022

Why it stopped: Trial terminated by Sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Celiac DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03569007
Sponsor's protocol ID: CeD-LA-3001
Status last verified: Aug 2021
First submitted: 14 Jun 2018
Last updated: 26 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy

All Celiac Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD
ClinicalTrials.gov ID: NCT03569007
Acronym / sponsor ID: CeD-LA-3001
Conditions: Celiac Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial terminated by Sponsor
Enrolment: 307 participants (actual)
Lead sponsor: 9 Meters Biopharma, Inc.Industry (pharma, biotech, devices)
Study start: 29 May 2019 (actual)
Primary completion: 21 Jul 2022 (actual)
Study completion: 21 Jul 2022 (actual)
First posted: 26 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Larazotide 0.25 mg	Active comparator	Drug: LarazotideLarazotide 0.25 mg capsules TID
Larazotide 0.50 mg	Active comparator	Drug: LarazotideLarazotide 0.50 mg capsules TID
Placebo	Placebo comparator	Drug: Matching PlaceboMatching placebo capsules TID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months
On a gluten-free diet for at least 6 months
Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
Willing to maintain current gluten-free diet throughout participation in the study

Key exclusion criteria (2 listed)

Refractory celiac disease or severe complications of celiac disease
Chronic active GI disease other than celiac disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LarazotideAlso: INN-202Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules	Drug	Larazotide 0.25 mg, Larazotide 0.50 mg
Matching PlaceboAlso: placeboenteric-coated beads in gelatin capsules	Drug	Placebo

Primary outcome

Proportion of subjects who are binary responders
Time frame: 12 weeks
Reduction in CeD PRO Abdominal Domain scores

Results and safety

The study was stopped early (reason given: Trial terminated by Sponsor). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Individual participant dataSharing planned: No

Related trials for Celiac Disease

Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

160 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Larazotide in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 160 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Trial terminated by Sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who are binary responders (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03569007.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.