Study Information for Participants: Investigating a potential new treatment for those with Coeliac disease
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
This study aims to evaluate the safety and effectiveness of an investigational
medication in people with Coeliac disease. The study will include a 16-day gluten
challenge. The investigational medication, FB102, may block the immune responses
known to cause Coeliac disease. Gluten challenge is a standard study design
approach used in the clinical trial setting to evaluate potential therapeutics for
Coeliac disease.
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
Australia:
- Royal Adelaide Hospital -Port Rd, Adelaide SA 5000
- Royal Melbourne Hospital - 300 Grattan St, Parkville VIC 3052
- Sunshine Coast University Private Hospital - 6 Doherty St, Birtinya QLD 4575
- Wesley Research Institute - 451 Coronation Dr, Auchenflower QLD 4066
- Campbelltown Hospital - Therry Rd, Campbelltown NSW 2560
- Momentum St Leonards - Suite 404, Tower A, North Shore Health Hub, 7 Westbourne Street, St Leonards NSW 2065, Sydney, Australia
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
- Momentum Research,1 Market Grove, Hutt Central, Lower Hutt 5010
- Momentum Pukekohe - 6 Roulston Street, Pukekohe, Auckland 2120
Who can participate?
To take part in this study, you will need to meet all the following (other criteria apply):
- Documented diagnosis of Coeliac disease confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to screening
- On a gluten free diet (GFD) for at least 12 months, , with the exception of the oral
gluten challenge administered as a study procedure. - Weight ≥ 50 kg and ≤ 100 kg for men and ≥ 45 kg and ≤ 95 kg for women
- Aged 18 to 65 years old
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- History of or current diagnosis of any severe complication of Coeliac disease.
- Have any other chronic, active gastrointestinal disease such as
gastroesophageal reflux disease, inflammatory bowel disease, or irritable
bowel syndrome.
Please note, additional eligibility criteria apply and will be discussed in a phone call
with our team.
What is involved?
If you are deemed eligible for the study, your participation is expected to last
approximately 17 weeks, and you will be required to attend the study site up to 8
times. This includes:
- A screening period of 28 days that includes an intestinal biopsy to determine
the 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 effect of the gluten challenge on the gut health.
- Treatment with the investigational medication or a matching placebo
- A follow-up period from Day 33 to Day 122, during which you will need to return to the study site on day 70.
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.
Your participation in this research study has the potential to advance our
understanding of medical science, lead to improved treatments, and deliver better
health outcomes.
If you take part in the research study, there will be:
- Reimbursement of costs: For out-of-pocket expenses, such as travel and parking
- Free study-related medical care: You may gain access to new research treatments, before they are widely available.
- No overnight stays: All study visits are day clinic visits and telephone calls only.
What is 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.
Why is this study important?
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 gluten-free diet can be extremely challenging for
individuals with Coeliac disease, leading to intentional or unintentional breaks in the
diet. Despite the availability of gluten-free products in developed countries increasing
enormously during the last decades, their distribution varies between regions and
countries. Moreover, the cost of gluten-free products is very high compared to
gluten-containing food. The only available treatment for Coeliac disease is strict
life-long adherence to a gluten-free diet with its many associated challenges.
Furthermore, total avoidance of gluten when Coeliac disease patients attempt to
follow a gluten-free diet is challenging. As such, there is significant unmet medical
need for safe and effective alternative treatments.
Who is involved?
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 reduce or eliminate the
autoimmune response that attacks the small intestine resulting in Coeliac disease.
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This trial has been approved by an independent ethics committee
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