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This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | FB102 |
|
| B | Experimental | FB102 |
|
| C | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB102 | Biological | FB102 (10 mg/kg induction doses and 3 mg/kg or 5 mg/kg maintenance doses) or placebo arms in a 2:2:1 ratio. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the VCIEL | Vh:Cd and IEL Composite Scale (VCIEL) | 78 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Melbourne Hospital | Recruiting | Melbourne | Australia |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Other | Placebo |
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |