In This SectionTexas Health Research & Education Institute
Disease or Condition
Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease
This is a double-blind, placebo controlled study to evaluate the safety and efficacy of the study drug, larazotide acetate, in subjects with Celiac Disease.
Provide written informed consent.
Male or female subjects age 18 to 75 years, inclusive.
BMI between 18.5 and 40, inclusive.
Female subjects should be either post-menopausal (amenorrhea for at least 24 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) with a negative serum beta human chorionic gonadotropin (ßhCG) pregnancy test prior to entering the study and who agree to use acceptable methods of contraception for the duration of the study. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, patch or injectable) in use for 1 month prior to screening and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. All methods will be used from at least 2 weeks (4 weeks in the case of hormonal contraceptives) before randomization until the end of the follow-up period.
Subjects must have a diagnosis of Celiac Disease confirmed by duodenal / jejunal biopsy or by capsule endoscopy plus positive celiac serology test results =12 months before study entry.
Subjects with a positive serum anti-tTG (IgA or IgG) OR deamidated gliadin peptide (anti-DGP—IgA or IgG) antibodies as determined by screening serology.
Subjects with CeD-GSRS score of = 2.0 at screening AND at the end of placebo run-in phase prior to randomization.
During one month prior to the screening visit, subjects must have had one of the following symptoms at least once per week or four times during the month: diarrhea, abdominal pain, bloating, nausea or stomachache.
Subjects must have attempted a gluten-free diet for at least 12 consecutive months prior to screening and be willing to maintain their current diet for the duration of the study.
Subjects must be willing and able to refrain from taking the following types of prohibited medications: systemic or intestinal immune suppressants, chronic or continuous oral and IV antibiotics (>2 weeks administration), chronic or continuous non-steroidal anti-inflammatory drugs (NSAIDs) (>2 weeks administration), medications altering gastric pH, substances that alter intestinal permeability, laxatives and colonic therapies, pancreatic enzyme replacements, fibrates, probiotics, amphetamines (e.g., for ADHD), ezetimibe and herbal remedies.
Subjects must be willing to return for all scheduled study visits.
Subjects must be willing to refrain from illicit drug use and alcohol abuse throughout the duration of the study.
Subjects with Refractory Celiac Disease (RDC) Type 1 or Type 2 or severe complications of Celiac Disease (including, but not limited to, Enteropathy-associated T cell Lymphoma–EATL, ulcerative jejunitis, perforation, severe osteoporosis or malnutrition or any other severe complication of CeD).
Subjects suspected to have lymphoma or any other serious complications of Celiac Disease (special caution should be exercised in including subjects >50 years of age to exclude RCD and EATL, by the standard methods used at the site).
Subjects diagnosed with any chronic active GI disease other than Celiac Disease (e.g. Crohn’s Disease, Ulcerative Colitis, active Irritable Bowel Syndrome, microscopic colitis, active lactose intolerance, active Gastroesophageal Reflux Disease (GERD) not controlled by H2 blockers –H2 receptor antagonists), following diagnostic procedures that are standard at the site.
Subjects with diabetes (Type 1 or Type 2) or other autoimmune diseases that might interfere with the conduct of the study, such as autoimmune hepatitis, primary biliary cirrhosis, multiple sclerosis and systemic lupus erythematosus.
Subjects with known untreated small intestinal bacterial overgrowth (SiBo).
Subjects with significant co-morbid disease that by the investigators determination would make the subject unsuitable for enrollment, including unstable medical conditions (chronic obstructive pulmonary disease, angina, severe cardio-respiratory conditions, etc.).
Subjects who smoke or use nicotine or nicotine containing products. Ex-smokers must have stopped smoking or must have stopped using tobacco and/or nicotine-containing products for at least 6 months prior to entry into the study.
Subjects with symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study.
Subjects with any condition or clinically significant abnormal laboratory test results at the screening visit, including ECG, as determined by the Principal Investigator or designee physician, and confirmed by Alba’s Medical Monitor.
Pregnant or breast feeding subjects, or subjects wishing to become pregnant during the study period, or unwilling to use birth control if a woman of child bearing potential.
Subjects with a hemoglobin value below 8.5 g/dL, blood donation within the last 56 days, or donation of a unit of plasma in the last 7 days.
Subjects with a history of alcohol or drug abuse in past 2 years.
Subjects currently taking an excluded medication.
Subjects with a positive urine drug test at screening.
Subjects with a positive HIV, Hepatitis B surface antigen or Hepatitis C test.
Subjects with history of cancer, other than non-melanoma skin cancer or cervical
carcinoma-in-situ that has been treated successfully with curative therapy, as demonstrated by medical records.
Subjects participating in any clinical drug study within the past 30 days or has participated in a clinical study that ended within the past 30 days.
Subjects deemed inappropriate by the Principal Investigator.
Subjects with previous exposure to larazotide acetate (AT1001).