Are you currently experiencing

CELIAC DISEASE SYMPTOMS

even on a gluten free diet?

Learn more about the CeDLara (CeD-LA-3001), a phase 3 research study for people with Celiac Disease.

Am I Eligible?

About this Research Study

Currently, the only treatment to manage Celiac Disease symptoms is maintaining a gluten-free diet. Many people with celiac disease continue to have symptoms even while following a strict gluten-free diet.

The CeD-LA-3001 study is being conducted to determine if an investigational drug reduces symptoms of Celiac Disease when taken while maintaining a gluten-free diet.

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Can I Take Part?

In order to qualify for the CeDLara study, certain criteria must be met. Some of the basic criteria are listed below.

  • Are 18 years old or older
  • Were diagnosed with Celiac Disease more than 6 months ago
  • Are actively experiencing symptoms related to Celiac Disease
  • Have been on a gluten-free diet for at least 6 months

Other criteria must be met to participate. A study doctor will need to perform various health tests and examinations to confirm if you are able to participate in the CeDLara study.
There is no cost to you to participate in this study. Health insurance is not required to participate.


Take Pre-Screener

Frequently Asked Questions

  • You will first need to participate in a screening visit to determine if you qualify. This is a series of questions about your medical history and tests to determine whether you qualify for this research study. Tests will include blood and urine samples, a physical exam, questions about your health and treatments, and a full review of your medical history. If you qualify and agree to participate, you will enroll into the research study.

  • If you qualify to take part in this research study and agree to participate, you will be in the study for approximately 30 weeks, including about 8 visits to the study center. There are three study phases:

    Initial Screening Period (about 21 days):
    The study doctor will conduct various health examinations to confirm your eligibility to participate in the study. This includes a full physical exam, medical history and laboratory tests from blood and urine samples taken. You may also be asked to undergo an endoscopy with biopsy.


    Symptom Eligibility Period (about 21 days):
    During this time, you will track your symptoms in a daily electronic diary. This ensures you understand the diary system and gives doctors a baseline of symptoms to determine the effect of the study drug once treatment starts.


    Study Treatment Period (about 24 weeks):
    You will be asked:

    • To take the study drug (larazotide or placebo) three times daily.
    • To undergo various health exams, including blood and urine sample collection, to monitor your health.
    • To track your health daily in an electronic diary.
    • You can choose to leave the study at any time for any reason, without penalty to you.

  • The study drug being studied is a capsule taken by mouth three times each day. The active ingredient remains in the intestinal tract and is not absorbed into the body. The study will determine whether it can reduce symptoms of Celiac Disease in patients who have persistent symptoms despite being on a gluten-free diet.

  • If you qualify to participate, the oral study drug and all study-related procedures will be provided to you at no charge.

  • There are risks and benefits of taking part in any clinical research study. These risk and benefits are outlined in detail in the informed consent form that you must read and sign before you can take part in the study. For example, you may benefit from the frequent health assessments. You may also benefit from taking the study drug, although this cannot be guaranteed. Your health may get better, it may stay the same, or it may get worse. You should discuss the risks and benefits of participation with your health care providers.

    Study-related health assessments, along with any study-related drug, equipment, and supplies are provided at no charge to you. Often, reasonable study-related expenses (such as time and travel) will be reimbursed.

  • In order to qualify for the CeD-LA-3001 study, you must meet certain criteria, including:

    • 18 years old or older
    • Biopsy-diagnosed with Celiac Disease more than 6 months ago
    • Actively experiencing symptoms related to Celiac Disease
    • Following a gluten-free diet for at least 6 months

    Other criteria must also be met to participate. A study doctor will need to perform various health tests and examinations to confirm if you are able to participate in the CeDLara study. There is no cost to you to participate in this study. Health insurance is not required to participate.
    Take Pre-Screener

  • The Sponsor is coordinating with research sites to ensure the safety and welfare of participants. Sites are following local standards and guidelines, such as wearing masks, increased surface cleaning, social distancing as well as other activities. Speak to your study physician or study site team member to obtain more details.


About Celiac Disease

Celiac Disease (CeD) is an autoimmune disorder where the ingestion of gluten causes damage in the small intestine called villous atrophy. Villi are microscopic, finger-like tentacles that line the wall of the small intestine. In people with Celiac Disease, eating gluten causes an autoimmune reaction which erodes away the villi leaving a flat surface.
Over time, this reaction damages the small intestine's lining and prevents absorption of some nutrients. This damage to the intestine often causes abdominal pain, cramping, bloating, gas, diarrhea, fatigue, weight loss, and anemia, and can lead to serious complications.
Symptoms of Celiac Disease can be different in children and adults and vary from person to person. The most common signs and symptoms for adults are diarrhea, fatigue, and weight loss. Adults may also experience abdominal pain, cramping, bloating, gas, nausea, constipation, and vomiting. Other symptoms may include:

  • Anemia or unexplained iron-deficiency
  • Headaches, seizures, or migraines
  • Fatigue
  • Bone, joint pain, or arthritis
  • Damage to dental enamel
  • Mouth ulcers
  • Loss of bone density (osteoporosis) or softening of bone (osteomalacia)
  • Depression or anxiety
  • Tingling, numbness, or pain in the hands and feet
  • Itchy, blistery skin rash (dermatitis herpetiformis)
  • A biopsy of the small intestine is the only way to confirm the diagnosis of Celiac Disease. Before a biopsy is performed, doctors will do blood tests to test for specific antibodies in the blood. Elevated levels of certain antibody proteins indicate an immune reaction to gluten. If these tests are positive, your doctor may order an endoscopy to view your small intestine and to take a small tissue sample (biopsy) to analyze for damage to the villi. Without the biopsy showing the definitive changes, a diagnosis of celiac disease can be presumed but not confirmed.

  • Celiac Disease is a chronic autoimmune disease. Chronic means that it is long-lasting or persistent. Currently, there is no cure for Celiac Disease.
    Following a strict, lifelong gluten-free diet is the only way to manage Celiac Disease by removing the trigger for disease activity. A gluten-free diet helps heal damage to the small intestine, causing symptoms to resolve. Following a gluten-free diet also helps prevent future complications.

    • Barley
    • Bulgur
    • Durum
    • Farina
    • Graham flour
    • Malt
    • Rye
    • Semolina
    • Spelt (a form of wheat)
    • Triticale
  • There is no cure for Celiac Disease.
    Celiac Disease is a chronic autoimmune disease.
    Following a strict, lifelong gluten-free diet is the only way to manage Celiac Disease by removing the trigger for disease activity. A gluten-free diet helps heal damage to the small intestine, causing symptoms to resolve. Following a gluten-free diet also helps prevent future complications.

About Clinical Trials

WHAT IS A CLINICAL RESEARCH STUDY?

Clinical research studies, also called clinical trials, are research studies in which participants are asked to take an investigational drug under the supervision of a physician and other research professionals. An investigational drug is one that is not approved by a health authority such as the US Food and Drug Administration (FDA), Food Branch, Health Canada of Canada (Canada HPFB) or the European Medicines Agency (EMA).

Clinical research studies must be reviewed by an institutional review board (IRB) or ethics committee (EC). An IRB or EC is a group that is responsible for helping to protect the safety, rights and welfare of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.

WHO CONDUCTS CLINICAL RESEARCH STUDIES?

Governments and sponsor companies (such as pharmaceutical or biotechnology) typically run clinical research studies. They are responsible for creating a strict study protocol (a written description of a research study) that is acceptably safe and ensuring that all people involved follow it throughout the course of the study.

WHAT SHOULD I EXPECT?

Before you participate in a clinical research study, a detailed description of the study – as well as possible risks and benefits – will be provided in writing in an "informed consent form." This form will be shared and discussed with you. You will have an opportunity to ask any questions. You will be asked to review and sign the informed consent form prior to participating to confirm that you understand the study and its possible risks and benefits.

If you qualify, you will be eligible to enroll in the clinical research study. Once enrolled, feel free to discuss your research care with the study doctor or study team members at any time during the course of your study participation.

It is important for you to:

  • Attend all scheduled visits
  • Adhere to the treatment and follow-up schedules
  • Complete the e-diaries as required by protocol
  • Describe your physical state, feelings, and well-being accurately and honestly to the study doctor
  • Discuss any questions regarding the study with the study doctor

As a study participant, you will have the right to contact the study’s IRB or EC representative regarding your rights as a research participant. You will also have the right to leave the study at any time for any reason.

CAN I LEAVE THE STUDY IF I CHANGE MY MIND?

Participation in any clinical research study is always completely voluntary, and participants may withdraw from a clinical research study at any time for any reason without penalty or loss of medical care or benefits to which you are entitled. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely and arrange for further medical care and follow-up.