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Celiac DiseasePhase 2NCT01396213

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

A Phase 2 study testing Larazotide Acetate in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Celiac Disease
What is being tested?
Larazotide Acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
342 participants
Where
62 sitesin 2 countries
Study dates
7 Nov 2011to 20 Aug 2013
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States56 sites

  • Study site

    Alexandria, Virginia, 22304

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Bethlehem, Pennsylvania, 18017

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Charlottesville, Virginia, 22911

  • Study site

    Chattanooga, Tennessee, 37421

  • Study site

    Chesterfield, Michigan, 48047

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Dallas, Texas, 75321

  • Study site

    Denver, Colorado, 80222

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Edgewater, Florida, 32132

  • Study site

    Hagerstown, Maryland, 21742

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Lake Success, New York, 11042

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Marietta, Georgia, 30067

  • Study site

    Marlton, New Jersey, 08053

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Mesa, Arizona, 85206

  • Study site

    Missoula, Montana, 59808

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10032

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73160

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32806

  • Study site

    Perkasie, Pennsylvania, 18944

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Pittsburgh, Pennsylvania, 15243

  • Study site

    Portland, Oregon, 97210

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rochester, New York, 14618

  • Study site

    Rockford, Illinois, 61107

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Francisco, California, 94115

  • Study site

    Santa Monica, California, 90404

  • Study site

    Seattle, Washington, 98104

  • Study site

    St Louis, Missouri, 63141

  • Study site

    St. George, Utah, 84790

  • Study site

    Summerfield, Florida, 34491

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    West Des Moines, Iowa, 50266

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyoming, Michigan, 49519

Other trials in United States

Canada6 sites

  • Study site

    Abbotsford British Columbia, British Columbia, V2T3R7

  • Study site

    Edmonton, Alberta, T6G2X8

  • Study site

    Hamilton, Ontario, L854J9

  • Study site

    Kelowna, British Columbia, V1Y1Z9

  • Study site

    Vancouver, British Columbia, V6Z2K5

  • Study site

    Victoria, British Columbia, V8V3P9

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Celiac Disease
Being tested
Larazotide Acetate, placebo
Keywords
larazotide acetate
Medical subject headings
Celiac Disease

What participants receive

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

  • Larazotide AcetateDrug

    Also called AT-1001, INN-202

    gelatin capsule

  • placeboDrug

    gelatin capsule

Study groups in NCT01396213
Study groupRoleWhat they receive
Larazotide Acetate 0.5 mgExperimentallarazotide acetate 0.5 mg capsules TID
Receives: Drug: Larazotide Acetate
Larazotide Acetate 1 mgExperimentallarazotide acetate 1 mg capsules TID
Receives: Drug: Larazotide Acetate
Larazotide Acetate 2 mgExperimentallarazotide acetate 2 mg capsules TID
Receives: Drug: Larazotide Acetate
PlaceboPlacebo comparatorplacebo capsules TID
Receives: Drug: placebo

What is being measured

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

  1. 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).

    Measured: CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.

Secondary outcomes (3)

  1. 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

    Measured: Up to 12 weeks

  2. 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.

    Measured: The CeD PRO was administered daily throughout the study.

  3. 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.

    Measured: 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.

Timeline

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

  1. First posted18 Jul 2011 (estimated)
  2. Study start7 Nov 2011
  3. Primary completion20 Aug 2013
  4. Study completion20 Aug 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, placebo-controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01396213
Sponsor's protocol ID
Clin1001-012
Status last verified
Sep 2017
First submitted
14 Jul 2011
Last updated
20 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25683116

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Larazotide Acetate in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 62 sites in 2 countries.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet (time frame: CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.). 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 NCT01396213, which also lists 1 linked publication.

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 20 Sep 2017.

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Clinical Trial NCT01396213 | AzTrials