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.

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.

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.

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.

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.

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.

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

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

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