Celiac DiseasePhase 2NCT00492960
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
A Phase 2 study testing larazotide acetate and 900 mg gluten in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 23 sites in 2 countries.
Trial summary
This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- larazotide acetate and 900 mg gluten
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Aug 2007to Mar 2009
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
- Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
- BMI between 18.5 and 38, inclusive.
Who cannot join
- Has chronic active GI disease other than celiac disease
- Has diabetes (Type 1 or Type 2).
- Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
- Has hemoglobin value below 8.5 g/dL
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States17 sites
Study Site
Asheville, North Carolina, 28801
Study Site
Boston, Massachusetts, 02215
Study Site
Chicago, Illinois, 60637
Study Site
Cleveland, Ohio, 44195
Study Site
Colorado Springs, Colorado, 80907
Study Site
Hagerstown, Maryland, 21740
Study Site
Houston, Texas, 77030
Study Site
Lexington, Kentucky, 40536
Study Site
New York, New York, 10032
Study Site
Philadelphia, Pennsylvania, 19107
Study Site
Pittsburgh, Pennsylvania, 15243
Study Site
Plano, Texas, 75093
Study Site
Richmond, Virginia, 23298
Study Site
Rochester, Minnesota, 55905
Study Site
Scottsdale, Arizona, 85259
Study Site
Seattle, Washington, 98101
Study Site
Troy, Michigan, 48084
Canada6 sites
Study Site
Calgary
Study Site
Edmonton, Alberta
Study Site
Kelowna, British Columbia
Study Site
Montreal
Study Site
Toronto
Study Site
Winnipeg
About this study
Official title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge
This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
Read the detailed description
This was a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter Study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.
- Conditions
- Celiac Disease
- Being tested
- larazotide acetate, placebo, 900 mg gluten
- 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 capsules
placeboDrug
gelatin capsules
900 mg glutenDietary supplement
gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Larazotide acetate 1 mg | Experimental | larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks Receives: Drug: larazotide acetate; Dietary Supplement: 900 mg gluten |
| Larazotide acetate 4 mg | Experimental | larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks Receives: Drug: larazotide acetate; Dietary Supplement: 900 mg gluten |
| Larazotide acetate 8 mg | Experimental | larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks Receives: Drug: larazotide acetate; Dietary Supplement: 900 mg gluten |
| Placebo | Placebo comparator | placebo capsules TID + 900 mg gluten capsules TID for 6 weeks Receives: Drug: placebo; Dietary Supplement: 900 mg gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
Measured: Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.
Secondary outcomes (2)
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
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 6 weeks
To prospectively validate a composite, weighted index of celiac disease activity
Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire
Measured: GSRS was completed weekly throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo Controlled, dose ranging, multicenter Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- 9 Meters Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Leon, MD, Ph.D., Study director, Alba Therapeutics Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492960
- Sponsor's protocol ID
- CLIN1001-006
- Status last verified
- Sep 2017
- First submitted
- 25 Jun 2007
- 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
Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.
PubMed 23163616
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge
- ClinicalTrials.gov ID
- NCT00492960
- Acronym / sponsor ID
- CLIN1001-006
- Conditions
- Celiac Disease
- Keywords
- larazotide acetate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- 9 Meters Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007 (actual)
- Primary completion
- Oct 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Jun 2007 (estimated)
- 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.
This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
Detailed description
This was a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter Study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo Controlled, dose ranging, multicenter Study
| Arm | Type | Receives |
|---|---|---|
| Larazotide acetate 1 mg | Experimental | Drug: larazotide acetate, Dietary Supplement: 900 mg glutenlarazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks |
| Larazotide acetate 4 mg | Experimental | Drug: larazotide acetate, Dietary Supplement: 900 mg glutenlarazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks |
| Larazotide acetate 8 mg | Experimental | Drug: larazotide acetate, Dietary Supplement: 900 mg glutenlarazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks |
| Placebo | Placebo comparator | Drug: placebo, Dietary Supplement: 900 mg glutenplacebo capsules TID + 900 mg gluten capsules TID for 6 weeks |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
- Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
- BMI between 18.5 and 38, inclusive.
Key exclusion criteria (4 listed)
- Has chronic active GI disease other than celiac disease
- Has diabetes (Type 1 or Type 2).
- Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
- Has hemoglobin value below 8.5 g/dL
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 |
|---|---|---|
| larazotide acetateAlso: AT-1001, INN-202gelatin capsules | Drug | Larazotide acetate 1 mg, Larazotide acetate 4 mg, Larazotide acetate 8 mg |
| placebogelatin capsules | Drug | Placebo |
| 900 mg glutengelatin capsules | Dietary supplement | Larazotide acetate 1 mg, Larazotide acetate 4 mg, Larazotide acetate 8 mg, Placebo |
Primary outcome
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Time frame: Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
2 secondary outcomes
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
Time frame: Up to 6 weeks
To prospectively validate a composite, weighted index of celiac disease activity
Time frame: GSRS was completed weekly throughout the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Results publication: PubMed 23163616Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.
- Individual participant dataSharing planned: No
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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.
Francisco Leon, MD, Ph.D. study director
Alba Therapeutics Corp
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing larazotide acetate and 900 mg gluten in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 23 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 3 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 23 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?
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge. (time frame: Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.). 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 NCT00492960, 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.