Clinical Trial Recruiting

[JustJust]

Phase IIb Study to Study the Efficacy of AT1001 to Treat Celiac Disease

This study is currently recruiting participants.

Verified by Alba Therapeutics, November 2007

Sponsored by: Alba Therapeutics

Information provided by: Alba Therapeutics

ClinicalTrials.gov Identifier: NCT00492960

Purpose

This study will look at 3 doses of AT1001 for efficacy and safety for the treatment of celiac disease.

The primary efficacy outcome is to evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.

Condition Intervention Phase

Celiac Disease

Drug: AT-1001

Drug: placebo

Phase II

MedlinePlus related topics: Celiac Disease

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Official Title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During a Gluten Challenge

Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:

To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

To prospectively validate a composite, weighed index of celiac disease activity [ Time Frame: 6 weeks ]

Enrollment: 2007

Start Date: August 2007

Expected Completion Date: April 2008

Arms Assigned Interventions

1: Experimental

AT-1001 capsules 1 mg with 900mg gluten Drug: AT-1001

capsules, TID

2: Experimental

AT-1001 capsules 4 mg with 900 mg gluten Drug: AT-1001

capsules, TID

3: Experimental

AT-1001 capsules 8 mg with 900 mg gluten Drug: AT-1001

capsules, TID

4: Placebo Comparator

Drug placebo capsules with 900 mg gluten Drug: placebo

capsules, TID

Detailed Description:

This is an outpatient, randomized, double blind multicenter study. 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 (breakfast, lunch, and dinner). Gluten or gluten placebo capsules will be taken TID with each meal.

Eligibility

Ages Eligible for Study: 18 Years to 72 Years

Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Eligible subjects must meet all of the following criteria before being enrolled into the study:

Age between 18 and 72 years, inclusive.

Diagnosed with celiac disease for more than 6 months.

Anti-Tissue Transglutaminase (anti-tTG) less than 10 EU.

On a gluten-free diet for at least 6 months.

BMI between 18.5 and 38, inclusive.

Exclusion Criteria

Subjects meeting any one of the following criteria are not eligible for the study:

Current smoker.

Has chronic active GI disease other than celiac disease (e.g. Crohn's, Colitis).

Has diabetes (Type 1 or Type 2).

Unable to abstain from alcohol consumption for 48 hours prior to each intestinal permeability collection throughout the study.

Unable to refrain from consuming non-steroidal anti-inflammatory agents, including aspirin ("NSAIDs") for 48 hours prior to each intestinal permeability collection throughout the study.

Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001.

Presents with or has a history of dermatitis herpetiformis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492960

Contacts

Contact: Alba Therapeutics 1-877-415-3282 clintrials@albatherapeutics.com

Hide Study Locations

Locations

United States, Arizona

Study Site Recruiting

Scottsdale, Arizona, United States, 85259

United States, Colorado

Study Site Recruiting

Colorado Springs, Colorado, United States, 80907

United States, Illinois

Study Site Not yet recruiting

Chicago, Illinois, United States, 60637

United States, Kentucky

Study Site Recruiting

Lexington, Kentucky, United States, 40536

United States, Maryland

Study Site Recruiting

Hagerstown, Maryland, United States, 21740

United States, Massachusetts

Study Site Recruiting

Boston, Massachusetts, United States, 02215

United States, Michigan

Study Site Recruiting

Troy, Michigan, United States, 48084

United States, Minnesota

Study Site Recruiting

Rochester, Minnesota, United States, 55905

United States, New York

Study Site Recruiting

New York, New York, United States, 10032

United States, North Carolina

Study Site Recruiting

Asheville, North Carolina, United States, 28801

United States, Ohio

Study Site Not yet recruiting

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

Study Site Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Study Site Recruiting

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Study Site Recruiting

Plano, Texas, United States, 75093

Study Site Recruiting

Houston, Texas, United States, 77030

United States, Virginia

Study Site Recruiting

Richmond, Virginia, United States, 23298

United States, Washington

Study Site Recruiting

Seattle, Washington, United States, 98101

Canada

Study Site Not yet recruiting

Toronto, Canada

Study Site Not yet recruiting

Calgary, Canada

Study Site Not yet recruiting

Montreal, Canada

Study Site Recruiting

Winnipeg, Canada

Canada, Alberta

Study Site Not yet recruiting

Edmonton, Alberta, Canada

Canada, British Columbia

Study Site Not yet recruiting

Kelowna, British Columbia, Canada

Sponsors and Collaborators

Alba Therapeutics

Investigators

Study Director: Francisco Leon, MD, Ph.D. Alba Therapeutics Corp

More Information

Alba Therapeutics

Study ID Numbers: CLIN1001-006

First Received: June 25, 2007

Last Updated: November 20, 2007

ClinicalTrials.gov Identifier: NCT00492960

Health Authority: United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Alba Therapeutics:

Celiac Disease

Study placed in the following topic categories:

Metabolic Diseases

Gastrointestinal Diseases

Malabsorption Syndromes

Celiac Disease

Metabolic disorder

Intestinal Diseases

Additional relevant MeSH terms:

Digestive System Diseases

Nutritional and Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2007

U.S. National Library of Medicine, Contact Help Desk

U.S. National Institutes of Health, U.S. Department of Health & Human Services,

USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act

[happygirl]

One of the study criteria includes diagnosis via biopsy.

[Jestgar]

And you risk being put into the group that has to consume gluten.

[jerseyangel]

And you risk being put into the group that has to consume gluten.

No thank you! It's taken me two years to feel better.....sorry, but I'm never going back there

[debmidge]

God bless all those who are participating on our behalf....

[jerseyangel]

God bless all those who are participating on our behalf....

Yes I was thinking that myself, and should have added it.

[tom]

And you risk being put into the group that has to consume gluten.

Hehe hi Jess, I know you know this - EVERY group consumes gluten.

Of course the biggest risk is being in the placebo group.

I seriously cannot imagine anyone who suffered through the most severe of the possible symptoms EVER agreeing to ingest gluten for any reason or under any circumstances. (Does this skew the results when only those who never had multiple debilitating symptoms would even consider joining the trial?)

It appears to me that the AT-1001 literature equates celiac w/ leaky-gut. The efficacy of the drug is quantified w/ a measurement of the magnitude of leakiness.

I'm not convinced that the entire spectrum of celiac problems correlates 100% w/ leaky-gut.

I do, however, think the drug may turn out to be very effective in repairing/preventing leaky-gut.

[Jestgar]

- EVERY group consumes gluten.

For a properly controlled study you need 4 groups:

+gluten, +drug

-gluten, +drug

+gluten, -drug

-gluten, -drug

They need to be able to show that the drug itself doesn't cause harm. Yes, this should have been tested in normals, but you can't compare a disease group (Celiac) to a normal population in terms of their reaction to a drug.

[tom]

For a properly controlled study you need 4 groups:

+gluten, +drug

-gluten, +drug

+gluten, -drug

-gluten, -drug

I think that was phaseI.

They're on to trying to determine dosage now.

All 4 groups get gluten. One gets a placebo. (tsk-tsk for not reading the 1st post carefully enough! heehee )

Jess, have I ever told you how engineers like myself are jealous of actual scientists like you??

[Generic]

I signed up for it and I do get super sick. But I am willing to do it, if it will help people like my dad and my sister, who are too stubborn to go gluten free.

When I talked to them on the phone there is an 80% chance you will get gluten and of course a 20% chance you won't. They are testing at this point to see if it would help with CC and even symptoms of accidental glutening. Not for the intent of eating a pizza etc.

I have an appt. in Dec. If they say anything different I will let you guys know.

Wish me luck! I may need it.

[Jestgar]

(tsk-tsk for not reading the 1st post carefully enough! heehee )

Jess, have I ever told you how engineers like myself are jealous of actual scientists like you??

Well, we're jealous of your ability to actually keep organized and think linearly.

Generic! Wow! Let us know how it goes.

[jerseyangel]

I signed up for it and I do get super sick. But I am willing to do it, if it will help people like my dad and my sister, who are too stubborn to go gluten free.

When I talked to them on the phone there is an 80% chance you will get gluten and of course a 20% chance you won't. They are testing at this point to see if it would help with CC and even symptoms of accidental glutening. Not for the intent of eating a pizza etc.

I have an appt. in Dec. If they say anything different I will let you guys know.

Wish me luck! I may need it.

Wow! Good luck with it.

[buffettbride]

I signed up for it and I do get super sick. But I am willing to do it, if it will help people like my dad and my sister, who are too stubborn to go gluten free.

When I talked to them on the phone there is an 80% chance you will get gluten and of course a 20% chance you won't. They are testing at this point to see if it would help with CC and even symptoms of accidental glutening. Not for the intent of eating a pizza etc.

I have an appt. in Dec. If they say anything different I will let you guys know.

Wish me luck! I may need it.

Thanks so much for your willingness to be a subject for this testing and potentially risking your health to help others. Please let us know (if you can!) how it goes!

[blueeyedmanda]

Clinical trials are very interesting, I work in a hospital doing clinical trials with cancer patients. It is a very itneresting process.

[ravenwoodglass]

Absolutely nothing would ever convince me to be part of this type of testing. Not that they would take me with DH. My biggest concern with this med is that it seems to address the gut issues but not the neuro ones. I am curious if after testing they will be able to say that the med stops gluten absorption period, not just that it alleviates the gut symptoms. For the med to do that it would have to be able to stop gluten from crossing the mucous membranes and getting into the blood stream in the mouth not just the gut. Although it would be nice to be able to go out with the family to eat without days of illness afterwards my big fear is that once this gets on the market doctors will simply prescribe the pill and gloss over the need for dietary compliance.

[blueeyedmanda]

Absolutely nothing would ever convince me to be part of this type of testing. Not that they would take me with DH. My biggest concern with this med is that it seems to address the gut issues but not the neuro ones. I am curious if after testing they will be able to say that the med stops gluten absorption period, not just that it alleviates the gut symptoms. For the med to do that it would have to be able to stop gluten from crossing the mucous membranes and getting into the blood stream in the mouth not just the gut. Although it would be nice to be able to go out with the family to eat without days of illness afterwards my big fear is that once this gets on the market doctors will simply prescribe the pill and gloss over the need for dietary compliance.

You brought up a very good point. They should be looking at all the issues which come up with gluten. There are some people who never even experienced the GI issues.

[cruelshoes]

I seriously cannot imagine anyone who suffered through the most severe of the possible symptoms EVER agreeing to ingest gluten for any reason or under any circumstances. (Does this skew the results when only those who never had multiple debilitating symptoms would even consider joining the trial?)

I respetfully disagree. I signed up to participate. My symptoms are extremely severe. I spent years carrying an IV bag around with me in a backpack just to stay alive. A central line in ones chest to receive IV nutrition is pretty severe. I remember only too well the hours spent in the fetal position wondering what I could have done to deserve such pain. Not trying to talk up my own problems, only trying to say that I know what it is like to be really sick.

Should the drug ever become a reality and people choose not to take it, they shouldn't have to take it. I have not decided for myself if I will want to take it. But I believe the option should be there for those who choose to take it. My son is 9. He will be going off to college in less than 10 years. If this pill were something that would help him have a more normal experience, any short-term problems I may have will be worth it. If it were to help increase the compliance of people that are struggling with the diet, that can only be a good thing. It would only be another tool in the gluten-free tool kit - right alongside GFP Chocolate Truffle Brownies and Bette Hagman cookbooks.

I realize that I am throwing myself under the bus by making these statements. I know people have strong opinions on both sides of the issue. I wish everyone well with whatever decision they decide to make about the pill or the clinical trials as well. I wish myself well with it too - gulp!

[buffettbride]

I respetfully disagree. I signed up to participate. My symptoms are extremely severe. I spent years carrying an IV bag around with me in a backpack just to stay alive. A central line in ones chest to receive IV nutrition is pretty severe. I remember only too well the hours spent in the fetal position wondering what I could have done to deserve such pain. Not trying to talk up my own problems, only trying to say that I know what it is like to be really sick.

Should the drug ever become a reality and people choose not to take it, they shouldn't have to take it. I have not decided for myself if I will want to take it. But I believe the option should be there for those who choose to take it. My son is 9. He will be going off to college in less than 10 years. If this pill were something that would help him have a more normal experience, any short-term problems I may have will be worth it. If it were to help increase the compliance of people that are struggling with the diet, that can only be a good thing. It would only be another tool in the gluten-free tool kit - right alongside GFP Chocolate Truffle Brownies and Bette Hagman cookbooks.

I realize that I am throwing myself under the bus by making these statements. I know people have strong opinions on both sides of the issue. I wish everyone well with whatever decision they decide to make about the pill or the clinical trials as well. I wish myself well with it too - gulp!

I wholeheartedly agree with you. We have talked extensively with our daughter about this medication (who is also just 8 short years away from college). We don't see it as something to be used so she can gorge on pizza every day. Just because a pill keeps her from getting sick, doesn't mean non-GI symptoms won't exist after eating gluten. However, I see it as a way to make day-to-day living a little more reassuring, especially in instances of cross contamination (which is why this phase IIb is so important).

Also, while it is not my favorite argument for this study, when the medical community has a medicinal way to treat a disease, it becomes more widely diagnosed (think of all the IBS medications the last several years). More diagnosis = more awareness. It definitely seems like doctors don't take celiac disease as serious because there is not a lot a doctor can do to treat it--therefore not a lot of motivation to diagnose it. Maybe I'm a bit off base on that, but it seems like good logic to me.

[happygirl]

The drug doesn't work by "stopping" GI symptoms, it works by not allowing gluten to cross the barrier cells that cause it to be in a place where the autoimmune reaction occurs. It covers all symptoms because it stops the autoimmune reaction from occurring in the first place.

[buffettbride]

The drug doesn't work by "stopping" GI symptoms, it works by not allowing gluten to cross the barrier cells that cause it to be in a place where the autoimmune reaction occurs. It covers all symptoms because it stops the autoimmune reaction from occurring in the first place.

Thanks for clarifying. I wasn't sure exactly what the full intent of the medication was. That is good to know--and makes it that much more of a valuable tool.

[blueeyedmanda]

I know personally I look forward to having this drug available. I wish this study was open at my Hospital. I would look at going on to it. Philly and Pitt are too far.