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Coeliac Disease Study (FB102)

Gluten-free diet due to coeliac disease?

Be part of an important research study investigating a potential new treatment for Coeliac disease

Coeliac disease affects thousands of people across Australia and New Zealand with symptoms including pain, bloating, other gut issues and chronic fatigue. While many people diagnosed with Coeliac disease can control symptoms through a strict gluten free diet, some continue to experience symptoms even when refraining from gluten in their diet. This study aims to evaluate the safety and effectiveness of an investigational medication in the treatment of Coeliac disease. This potential new treatment is expected to block the immune responses known to cause Coeliac disease.

Eligibility criteria:

- Aged between 18 - 65 years
- Medically diagnosed with Coeliac disease
- Have been managing Coeliac disease symptoms with a gluten-free diet for at least 12 months

Further eligibility criteria will be assessed during pre-screening and screening.

Duration:

Approximately 17 weeks (approximately 9 study visits)

Locations:

Melbourne, VIC | Auckland, NZ | Waikato, NZ

If you take part in this research study, there will be:

Reimbursement of costs

For out-of-pocket expenses, such as time, travel and parking.

Contribution to medical research

Help investigate a potential new treatment that could improve the lives of individuals with Coeliac Disease in the future.

Free study-related medical care

Be among the first to participate in a study of a potential new therapy for Coeliac disease.

Convenience

There are no overnight stays.

Register your interest now

or scroll down to read the study FAQs

Study Guide

01

Who can take part in this study?

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To take part in this study, you will need to meet all the following (other criteria
apply):

  • Aged between 18 and 65 years old.
  • Have been medically diagnosed with Coeliac disease by intestinal biopsy
    and blood tests.
  • Have a body mass index (BMI) of 16 to 32 km/m2, with a weight of ≥ 50 kg and  ≤ 100 kg for men and ≥ 45 kg and ≤ 95 kg for women at screening.
  • Have been on a strict gluten-free diet for at least 12 months.
  • You are willing to consume food containing gluten protein (approximately equivalent to consuming two pieces of wheat bread) as part of a gluten challenge for 16 days.

02

Who is unable to take part in this study?

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Unfortunately, if any of the following apply to you, this study is not the right fit for
you:

  • Have any other chronic, active gastrointestinal disease such as
    gastroesophageal reflux disease, inflammatory bowel disease, or irritable bowel syndrome.
  • Significant uncontrolled medical conditions or diseases (these will be
    discussed during phone screening).
  • Pregnant or breastfeeding, or intend to become pregnant during the study
    or for at least 100 days after receiving the investigational medication.


Please note, additional eligibility criteria apply.

03

How long will this study take?

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If you are deemed eligible for the study, your participation is expected to last
approximately 17 weeks, with approximately 9 study visits. This includes:

 

  • A screening period of 28 days that includes an intestinal biopsy to
    determine the baseline gut health
  • A treatment period of 32 days, including:
    • Treatment with the investigational medication or a matching placebo on Days 1, 8, 15 and 22. A placebo looks like the study medicine but does not contain any study medicine (active ingredient). Researchers use a placebo to see if a study medicine is safer than not taking anything at all.
    • On Day 16, commencement of a 16-day gluten challenge at the study site.
  • Thereafter, two additional visits to the study site on Day 32 and the last observation on Day 70. The day 32 visit is the post treatment intestinal biopsy to determine the gut health at the conclusion of the gluten challenge.
This is a double-blind study, which means neither you nor the study doctor will
know if you receive the investigational medication or a placebo. Eligible
participants will have a 75% (three in four) chance of receiving the investigational
medication.

Participation in this research is voluntary, and you may withdraw from the study at
any time.

04

What is the purpose of this study?

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This study aims to evaluate the safety and effectiveness of an investigational
medicinal product, FB102, in Coeliac disease patients who are undergoing a gluten
challenge. FB102 is expected to block the immune responses known to cause
Coeliac disease when gluten is ingested. Gluten challenge is a standard study design approach used in the clinical trial setting to evaluate potential therapeutics for coeliac disease.

05

What is Coeliac disease?

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Coeliac disease is an autoimmune condition in which a person's immune system
mistakenly attacks their own gut tissues when they ingest gluten, a naturally
occurring protein found in wheat, barley, and rye. This can damage the small
intestine and impair the body’s ability to absorb nutrients. As such, after a person
with Coeliac disease eats gluten, they can experience fatigue, abdominal pain,
and a variety of digestive issues, including constipation, diarrhoea, and vomiting.

06

Why is this study important?

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Approximately 24% to 47% of participants have signs and symptoms of ongoing
active coeliac disease despite adhering to a gluten-free diet (GFD) most likely due
to continuous (inadvertent) gluten exposure.

Maintaining a lifelong strict GFD can be extremely challenging for individuals with
Coeliac disease leading to intentional or unintentional breaks in the diet. Despite
the availability of GF products in developed countries increasing enormously
during the last decades, their distribution varies between regions and countries.
Moreover, the cost of GF products is very high compared to gluten-containing
food. The only available treatment for Coeliac disease is strict life-long adherence
to a GFD with its many associated challenges. Furthermore, total avoidance of
gluten when Coeliac disease patients attempt to follow a GFD is near to
impossible. As such, there is significant unmet medical need for safe and effective
alternative treatments in addition to dietary avoidance of gluten.

07

Who is sponsoring this study?

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This study is being sponsored by Forte Biosciences, a pharmaceutical company
headquartered in Dallas, Texas, USA. Forte Biosciences is a clinical-stage
biopharmaceutical company whose lead product candidate is FB102.

FB102 is a proprietary molecule with potentially broad autoimmune and autoimmune-related applications. The company’s FB102 program aims to address key pathways implicated in these indications.

08

Where is my nearest study site?

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Here is a list of all of the sites who are currently recruiting for this study:

Australia:

  • Royal Melbourne Hospital - 300 Grattan St, Parkville VIC 3052

New Zealand:

  • Optimal Central Auckland - Level 2, 97 Grafton Road. Grafton, Auckland 1010.
  • PCRN Auckland - Level 2/2 Fred Thomas Drive, Takapuna, Auckland 0622
  • PCRN Waikato - 6 Avalon Drive, Nawton, Hamilton 3200

09

What if I have other questions about the study?

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Visit our Evrima Help Centre to view our FAQs, or if you wish to connect with our
patient experience team.

10

Further reading

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Click here to view the Study’s ANZCTR page (Australian New Zealand Clinical Trials
Registry)

This study has been approved by an independent Human Research Ethics Committee

Help make medical research breakthroughs happen.