Celiac DiseasePhase 2NCT00889473
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
A Phase 2 study testing Larazotide acetate and Gluten 900 mg in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 15 sites in 2 countries.
Trial summary
This study is designed to evaluate the efficacy of a single dose 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 Gluten 900 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Apr 2009to Apr 2010
- 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
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Study Site
Chesterfield, Michigan
Study Site
Franklin, Tennessee
Study Site
Hagerstown, Maryland
Study Site
Lexington, Kentucky
Study Site
New York, New York
Study Site
Oklahoma City, Oklahoma
Study Site
Orange, California
Study Site
Paoli, Pennsylvania
Study Site
Philadelphia, Pennsylvania
Study Site
Pittsburgh, Pennsylvania
Study Site
Rochester, Minnesota
Study Site
Silver Spring, Maryland
Study Site
Topeka, Kansas
Study Site
Troy, Michigan
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 is designed to evaluate the efficacy of a single dose 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 study is an extension of Study CLIN1001-006 (NCT 00492960). This is 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 will remain on their gluten-free diet throughout the duration of the trial.
Study drug or drug placebo capsules will be 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, Gluten 900 mg
- Keywords
- larazotide acetate, gluten
- 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 AT1001, INN-202
gelatin capsule
PlaceboDrug
gelatin capsule
Gluten 900 mgDietary supplement
gelatin capsule
| 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: Gluten 900 mg |
| Placebo | Placebo comparator | placebo capsules TID + 900 mg gluten capsules TID for 6 weeks Receives: Drug: Placebo; Dietary Supplement: Gluten 900 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to gluten
Measured: 6 weeks
Secondary outcomes (1)
Anti-transglutaminase
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionApr 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, dose ranging, multicenter
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- 9 Meters Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Leon, MD, PhD, Study director, Alba Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889473
- Sponsor's protocol ID
- CLIN1001-006 Part B
- Status last verified
- Sep 2017
- First submitted
- 27 Apr 2009
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- NCT00889473
- Acronym / sponsor ID
- CLIN1001-006 Part B
- Conditions
- Celiac Disease
- Keywords
- larazotide acetate, gluten
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- 9 Meters Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Apr 2009 (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 is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease
Detailed description
This study is an extension of Study CLIN1001-006 (NCT 00492960). This is 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 will remain on their gluten-free diet throughout the duration of the trial.
Study drug or drug placebo capsules will be 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
- 2
- Model description
- randomized, double-blind, placebo-controlled, dose ranging, multicenter
| Arm | Type | Receives |
|---|---|---|
| Larazotide acetate 1 mg | Experimental | Drug: Larazotide acetate, Dietary Supplement: Gluten 900 mglarazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks |
| Placebo | Placebo comparator | Drug: Placebo, Dietary Supplement: Gluten 900 mgplacebo 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: AT1001, INN-202gelatin capsule | Drug | Larazotide acetate 1 mg |
| Placebogelatin capsule | Drug | Placebo |
| Gluten 900 mggelatin capsule | Dietary supplement | Larazotide acetate 1 mg, Placebo |
Primary outcome
Response to gluten
Time frame: 6 weeks
1 secondary outcome
Anti-transglutaminase
Time frame: 6 weeks
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.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease
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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, PhD study director
Alba Therapeutics Inc
15 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 Gluten 900 mg in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 15 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 15 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?
Response to gluten (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.