The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD).
- Category
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Trial status
Recruiting
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Trial phase
Phase 2 Drug TrialEarly stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
- Registry listing
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ERM Project ID
105356
Trial contact details
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Contact person
IBD Clinical Trials Team
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Phone
07 3163 8195
What you need to know
Who can take part?
Do you have celiac disease and are on a gluten free diet?
To participate, you must:
- Have biopsy confirmed Celiac Disease
- Must be confirmed with the disease genotype required for study participation (tested during screening)
- Be aged 18 - 75 years
- Have been on a gluten free diet for at least 6 months and be able to maintain that gluten free diet for a further 6 months
- Not have any other gastrointestinal disorders or autoimmune diseases
- Not have a known or suspected wheat allergy
- Meet medication requirements per protocol
- Not have active infection
- Not have a history of malignancy
- Not be pregnant/breastfeeding or planning a pregnancy
What is involved for me?
- Regular study visits
- Maintain Gluten free diet
- Be willing to undergo gluten challenges
- Treatment via infusion (into the vein)
- Physical exam
- ECG
- Blood & urine testing
- Daily diary completion
