John Libonati

Medical Research Study to Test a Potential Celiac Disease Therapy Is Underway and Signing up Participants

by John Libonati on June 18th, 2012


There is no cure for celiac disease. But, there may soon be a new therapy to go along with a gluten-free diet.

A Phase II medical research study to test a potential therapy for people with celiac disease is underway and signing up participants at CeliacTrial.com.

celiac disease fasano

Alessio Fasano, MD. Co-founder of Alba Therapeutics

The investigational drug, Larazotide Acetate, was developed by Alba Therapeutics. It passed Phase I trials and is now being studied to determine how effective it is in different doses and whether side effects develop. Alba Therapeutics was co-founded by celiac disease researcher, Dr. Alessio Fasano, director of the Celiac Disease Center at the University of Maryland.1

The therapy is based on Dr. Fasano’s discovery that tight junctions between cells in the intestine can be opened or closed and that gluten relaxes these junctions. It is this process that leads to gluten improperly crossing into the body, thereby eliciting an immune reaction that leads to inflammation and damage characteristic of celiac disease.

“The reality is that the paracellular space is a gate, not a wall or fence. And if material gets through that space – even if it is only 1 to 5% of what normally travels through the cell – it could be associated with disease.”
-Alessio Fasano, MD1

Dr. Fasano discovered the potentially therapeutic utility of down-regulating intestinal permeability of celiac disease.1 In other words, he discovered that stopping tight junctions from inappropriately relaxing could be a way to treat celiac disease.

What Is Larazotide Acetate?

Larazotide acetate is a non-absorbed medication which improves intestinal lining barrier function by inhibiting cellular reorganization and tight junction disassembly.2 In other words, it stops normally tight junctions between cells that line the small intestine from relaxing in the presence of gluten. Larazotide acetate is orally formulated (a capsule), has been granted “Fast Track” designation by the U.S. Food and Drug Administration for the treatment of Celiac disease, and is also being evaluated for the treatment of Crohn’s Disease.2

It is important to note that Larazotide Acetate is not being touted as a possible cure. It is a therapy to be used in conjunction with a strict gluten-free diet. Basically, slip ups can happen and people can be inadvertently exposed to gluten. Larazotide Acetate is believed to minimize the damage such exposure would cause.1

Phase I Trial: (This initial study of Larazotide Acetate is finished and the results are published.)

According to Daniel Leffler, MD, a gastroenterologist at Beth Israel Deaconess Medical Center and one of the lead investigators for the Phase I trial, “This study showed that larazotide acetate prevented immunologic changes induced by gluten in patients with celiac disease.”2 According to the conclusions of the Phase I trial, the larazotide acetate appeared to work.3

Results of the Alba Therapeutics’ first study in patients with celiac disease are available online here.

Phase II Trial: (This active study is called “A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease4)

The Phase II study began in October 2011. Now Alba Therapeutics is seeking participants to determine the most appropriate dose of Larazotide Acetate. Doctors in locations across the United States are involved. People who are medically diagnosed with celiac disease, on a gluten-free diet, but still experiencing symptoms are signing up.

Purpose of the Phase II Trial:

A randomized, double-blind, placebo-controlled Phase IIB 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.4

Study Description:

This is a double-blind, placebo-controlled Phase IIB study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg) of Larazotide Acetate as a support to the gluten-free diet in the treatment of patients with celiac disease. The diagnosis of celiac disease must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Participants must have symptoms despite being on a gluten-free diet. Participants will remain on a gluten-free diet throughout the trial. So, nothing changes except that they will be receiving the Larazotide Acetate capsule or a placebo.4

What Does Double Blind Mean?

Double blind means neither the people in the study nor the researchers will know whether a participant is receiving the therapy or a placebo.

Study Inclusion/Exclusion Criteria (From CeliacTrial.com)5

In order to qualify for this celiac therapy study you must meet the following criteria:5

  • Must be aged 18-75 years to participate
  • Have been diagnosed with Celiac Disease
  • Have been on a gluten-free diet for 12 months or longer when you begin the study
  • Must be willing to take treatment daily in conjunction with your current diet
  • Must be experiencing certain Celiac Disease symptoms
  • Must not be diagnosed with refractory celiac disease.
  • Must not be diagnosed with chronic active GI disease, such as irritable bowel syndrome, inflammatory bowel disease etc.
  • Must not be diagnosed with severe complications of celiac diseases

 

When you qualify for this study, you will receive:5

  • Monitoring of your Celiac Disease by a medical team at no cost to you
  • Study drug or placebo (which means no change in what you currently are doing by following your current diet)
  • Compensation to cover your time and travel expenses
  • The study doctor will see you monthly over the next 5 months
  • Your medical information is kept strictly confidential, however patients in the study are encouraged to share their involvement in the study with their doctor. Being involved in the study, does not mean you have to cut ties with your current doctors.

 

You should know that:5

  • The study doctor will see you monthly over the next 5 months
  • Your medical information is kept strictly confidential, however patients in the study are encouraged to share their involvement in the study with their doctor. Being involved in the study, does not mean you have to cut ties with your current doctors.

 

celiac disease drug websiteThe Pre-Screening Process

The pre-screening process consists of a questionnaire on CeliacTrial.com. The questionnaire is roughly 45 questions on three pages. Questions are mostly concerned with current symptoms, whether you were diagnosed with celiac disease and contact information. At the end of the questionnaire, a thank you page is presented that informs you that someone will contact you and lists the study locations nearest you and their distances.

Summary5

  • The test is only open to people 18 to 75 years of age, who are medically diagnosed with celiac disease and have been on a gluten-free diet for at least a year but still have symptoms.
  • Alba is testing to see how effective their drug is at reducing symptoms for people who still have problems, even after maintaining a gluten-free diet for a year.
  • Alba’s therapy is based on the idea that if it closes the tight junctions in the intestine, gluten will be unable to penetrate. The study will determine this, the most effective doses, as well as whether any side effects are noticed.
  • Participants will be under the supervision of a physician at no cost to them. They will also be paid for time and travel.


Celiac Therapy Study Locations:
4

This clinical research study for Celiac Disease is being conducted by medical researchers across the United States and Canada. Locations are listed below.

UNITED STATES:

Alabama

Birmingham, Alabama, 35209

Arizona

Mesa, Arizona, 85206

Tucson, Arizona, 85704

California

Oceanside, California, 92056

Orange, California, 92868

San Francisco, California, 94115

Santa Monica, California, 90404

Colorado

Denver, Colorado, 80222

Connecticut

Norwalk, Connecticut, 06851

Florida

Boynton Beach, Florida, 33426

Edgewater, Florida, 32132

Orlando, Florida, 32806

Summerfield, Florida, 34491

Georgia

Marietta, Georgia, 30067

Illinois

Oak Lawn, Illinois, 60453

Iowa

West Des Moines, Iowa, 50266

Kansas

Wichita, Kansas, 67207

Kentucky

Lexington, Kentucky, 40536

Louisville, Kentucky, 40202

Maryland

Baltimore, Maryland, 21229

Hagerstown, Maryland, 21742

Towson, Maryland, 21286

Massachusetts

Boston, Massachusetts, 02215

Michigan

Chesterfield, Michigan, 48047

Wyoming, Michigan, 49519

Minnesota

Rochester, Minnesota, 55905

Mississippi

Jackson, Mississippi, 39202

Montana

Missoula, Montana, 59808

Nevada

Las Vegas, Nevada, 89119

New Jersey

Marlton, New Jersey, 08053

New York

New York, New York, 10032

New York, New York, 10075

Rochester, New York, 14618

North Carolina

Boone, North Carolina, 28607

Cary, North Carolina, 27518

Salisbury, North Carolina, 28144

Winston-Salem, North Carolina, 27103

Ohio

Cleveland, Ohio, 44195

Mentor, Ohio, 44060

Oklahoma

Oklahoma City, Oklahoma, 73160

Oregon

Portland, Oregon, 97210 (Not yet recruiting)

Pennsylvania

Perkasie, Pennsylvania, 18944

Philadelphia, Pennsylvania, 19107

Pittsburgh, Pennsylvania, 15243

Rhode Island

Warwick, Rhode Island, 02886

Tennessee

Chattanooga, Tennessee, 37421

Franklin, Tennessee, 37067

Texas

Dallas, Texas, 75321

Fort Worth, Texas, 76104

San Antonio, Texas, 78229

Sugar Land, Texas, 77479

Utah

Salt Lake City, Utah, 84109

St. George, Utah, 84790 (Not yet recruiting)

Virginia

Alexandria, Virginia, 22304

Charlottesville, Virginia, 22911


CANADA:

Alberta

Edmonton, Alberta, T6G2X8

British Columbia

Abbotsford, British Columbia, V2T3R7

Kelowna, British Columbia, V1Y1Z9

Vancouver, British Columbia, V6Z2K5

Victoria, British Columbia, V8V3P9

Ontario

Hamilton, Ontario, L854J9


 

About Alba Therapeutics Corporation

Alba Therapeutics Corporation is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of therapies to treat auto-immune, immune mediated and inflammatory diseases and is located in Baltimore, Maryland.2 For more information about Alba’s clinical trials, visit the www.clinicaltrials.gov web site and search for Alba Therapeutics.

 

Sources:

1. Alba Therapeutics Corp. – Leveraging the third precondition for autoimmune disease initiation. Albatherapeutics.com. http://www.albatherapeutics.com/Default.aspx?tabid=189
2. Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific Meeting. Drugs.com. http://www.drugs.com/clinical_trials/alba-therapeutics-presents-new-data-larazotide-acetate-2008-american-college-gastroenterology-5723.html

3. Patterson, BM, Lammers KM, Arrieta MC, Fasano A, Meddings JB. The safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in coeliac disease subjects: a proof of concept study. Alimentary Pharmacology & Therapeutics. (Volume 26, Issue 5), 19 JUN 2007. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2007.03413.x/pdf

4. Phase II Trial: “A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease. ClinicalTrials.Gov. http://clinicaltrials.gov/ct2/show/NCT01396213?term=celiac+disease&rank=5

5. CeliacTrial.com

 

———————–
Author Information: John Libonati, Philadelphia, PA
Publisher, Glutenfreeworks.com.
Editor & Publisher, Recognizing Celiac Disease.
John can be reached by e-mail here.

 


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