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 33 weeks, with approximately 16 study visits. This includes:

• A screening period of up to 45 days that includes an intestinal biopsy to determine the baseline gut health
• A treatment period of 11 weeks, including:

○ Treatment with the investigational medication or a matching placebo on Days 1, 4, 8, 15, 22, 23, 25, 29, 32, 43, 57, 71 and 78. 

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 23, a 54-day gluten challenge will commence

The day 78 visit is the post treatment intestinal biopsy to determine the gut health at the conclusion of the gluten challenge

• Thereafter, two additional visits to the study site on Day 127 and the last observation on Day 183.  

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. 

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 celiac 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.

Evrima is an Australian based participant recruitment agency engaged by Forte Biosciences to support recruitment into this study.  Evrima is not the study team engaged in this study, however if you are eligible to participate we will connect you with the study team.

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

Victoria

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

New South Wales

• Momentum Clinical Research St Leonards - 7 Westbourne Street, St Leonards, NSW 2065

Queensland

• Coral Sea Clinical Research Institute - Suite 7, Mater Medical Suites, 76  Willetts Road, North Mackay QLD 4740

South Australia

• Royal Adelaide Hospital (Gastroenterology unit) - GI Clinical Trials, Room 5E291, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000

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

New Zealand

• Pacific Clinical Research Network (PCRN) Christchurch - Level 2, Forte 2, 132 Peterborough St Christchurch 8013
• Pacific Clinical Research Network (PCRN) Tasman - 9 Bail Street, Stoke, Nelson 7011, New Zealand
• Optimal Clinical Trials Central Auckland - Level 2/97 Grafton Road, Grafton, Auckland 1010, New Zealand
• Optimal Clinical Trials North - 
• Momentum Clinical Research Wellington - First Floor 121 Adelaide Road, Mt Cook
• PCRN - Level 2/2 Fred Thomas Drive, Takapuna, Auckland 0622
  
• Lakeland Clinical Trials Waikato - 6 Avalon Drive, Nawton, Hamilton 3200, New Zealand
• Lakeland Clinical Trials Wellington - Queen Street Carpark, Queen Street, Ebdentown, Upper Hutt 5018 

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