Celiac DiseasePhase 2NCT00620451
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
A Phase 2 study testing larazotide acetate in people with Celiac Disease, run by 9 Meters Biopharma, Inc. at 33 sites in 3 countries.
Trial summary
This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease. 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
- 105 participants
- Where
- 33 sitesin 3 countries
- Study dates
- Feb 2008to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
- Marsh score ≥ II at screening
- Positive serum anti-tTG antibodies as determined by screening serology
- Willing to comply with a gluten-free diet for the duration of the study
Who cannot join
- Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
- Has chronic active GI disease other than Celiac Disease
- Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
- Has hemoglobin value below 8.5 g/dL
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
United States20 sites
Study Site
Asheville, North Carolina, 28801
Study Site
Chesterfield, Michigan, 48047
Study Site
Franklin, Tennessee, 37067
Study Site
Gallipolis, Ohio, 45631
Study Site
Hagerstown, Maryland, 21740
Study Site
Harrisburg, North Carolina, 28075
Study Site
Houston, Texas, 77030
Study Site
Jacksonville, Florida, 32207
Study Site
Lexington, Kentucky, 40536
Study Site
Orange, California, 92868
Study Site
Paoli, Pennsylvania, 19301
Study Site
Philadelphia, Pennsylvania, 19014
Study Site
Pittsburgh, Pennsylvania, 15243
Study Site
Rochester, Minnesota, 55905
Study Site
San Francisco, California, 94115
Study Site
Silver Spring, Maryland, 20901
Study Site
Sioux Falls, South Dakota, 57105
Study Site
Topeka, Kansas, 66606
Study Site
Torrington, Connecticut, 06790
Study Site
Troy, Michigan, 48084
Spain9 sites
Study Site
Barcelona, 08028
Study Site
Huesca, 22004
Study Site
León, 24005
Study Site
Madrid, 28007
Study Site
Madrid, 28034
Study site
Madrid, 28040
Study Site
Palma, Mallorca, 07014
Study Site
Reus, 43201
Study Site
Valladolid, 47005
Canada4 sites
Study Site
Abbotsford British Columbia, British Columbia, V5ZIH2
Study Site
Edmonton, Alberta, T6G2X8
Study Site
Kelowna, British Columbia, V1Y2H4
Study Site
Richmond Hill, Ontario, L4B3PB
About this study
Official title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)
This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.
Read the detailed description
This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and placebo TID in subjects with celiac disease. The primary objective was to assess the efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease, as defined by an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio, obtained by duodeno-jejunal biopsy. Secondary objectives included assessment of the safety and tolerability of larazotide acetate, to prospectively validate the components of a composite weighted index of celiac disease activity (celiac disease Activity Rating Score, CeDARS), individually and as a whole, to To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index and the Short Form 12 version 2 (SF-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease.
- Conditions
- Celiac Disease
- Being tested
- larazotide acetate, placebo
- Keywords
- Treatment, Active, Celiac, Remission, Induction
- Medical subject headings
- Celiac Disease, Motor Activity
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 group | Role | What they receive |
|---|---|---|
| Larazotide acetate 4 mg | Experimental | larazotide acetate capsules 4 mg TID Receives: Drug: larazotide acetate |
| Larazotide acetate 8 mg | Experimental | Larazotide acetate capsules 8 mg TID Receives: Drug: larazotide acetate |
| Placebo | Placebo comparator | Placebo capsules Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.
Measured: duodeno-jejunal biopsies were performed at Baseline and Day 56
Secondary outcomes (4)
Assess the safety and tolerability of larazotide acetate
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results and ECG results. Plasma larazotide acetate and metabolites, as well as potential serum antibodies against larazotide acetate, were also determined.
Measured: Up to 8 weeks
To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole.
Candidate components of the CeDARS Index measured in this study were GSRS, anti-tTG antibodies, LAMA ratio, Hb, ferritin, body weight, triceps skin fold thickness, BMI, urinary nitrates
Measured: Up to 8 weeks
To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey.
The CGA was completed by the PI or designee; the PWBI and SF-12v2 were completed by the subject.
Measured: CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.
To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects
Blood for serum was drawn for potential future determination of inflammatory mediators that might be involved in the response of Celiac Disease to larazotide acetate, such as cytokines (e.g. TNF-α,IFN-γ) or the putative permeability factor "zonulin".
Measured: Blood draws occurred at Visits 1, 2, 3, 4 and 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionDec 2009
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, parallel- group, double-blind, multicenter
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620451
- Sponsor's protocol ID
- AT1001-011
- Status last verified
- Sep 2017
- First submitted
- 7 Feb 2008
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)
- ClinicalTrials.gov ID
- NCT00620451
- Acronym / sponsor ID
- AT1001-011
- Conditions
- Celiac Disease
- Keywords
- Treatment, Active, Celiac, Remission, Induction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- 9 Meters Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Feb 2008 (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 assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.
Detailed description
This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and placebo TID in subjects with celiac disease. The primary objective was to assess the efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease, as defined by an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio, obtained by duodeno-jejunal biopsy. Secondary objectives included assessment of the safety and tolerability of larazotide acetate, to prospectively validate the components of a composite weighted index of celiac disease activity (celiac disease Activity Rating Score, CeDARS), individually and as a whole, to To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index and the Short Form 12 version 2 (SF-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- randomized, parallel- group, double-blind, multicenter
| Arm | Type | Receives |
|---|---|---|
| Larazotide acetate 4 mg | Experimental | Drug: larazotide acetatelarazotide acetate capsules 4 mg TID |
| Larazotide acetate 8 mg | Experimental | Drug: larazotide acetateLarazotide acetate capsules 8 mg TID |
| Placebo | Placebo comparator | Drug: placeboPlacebo capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
- Marsh score ≥ II at screening
- Positive serum anti-tTG antibodies as determined by screening serology
- Willing to comply with a gluten-free diet for the duration of the study
Key exclusion criteria (4 listed)
- Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
- Has chronic active GI disease other than Celiac Disease
- Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of 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 capsule | Drug | Larazotide acetate 4 mg, Larazotide acetate 8 mg |
| placebogelatin capsule | Drug | Placebo |
Primary outcome
Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
Time frame: duodeno-jejunal biopsies were performed at Baseline and Day 56
Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.
4 secondary outcomes
Assess the safety and tolerability of larazotide acetate
Time frame: Up to 8 weeks
To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole.
Time frame: Up to 8 weeks
To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey.
Time frame: CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.
To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects
Time frame: Blood draws occurred at Visits 1, 2, 3, 4 and 5.
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.
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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
33 sites in 3 countries: see every site and its status.
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 33 sites in 3 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 4 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 33 sites in United States, Spain, 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 in inducing remission in subjects with active celiac disease (time frame: duodeno-jejunal biopsies were performed at Baseline and Day 56). 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.