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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023127-23 | EudraCT Number |
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A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALV003 | Experimental | ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten. |
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| Placebo | Placebo Comparator | Excipients for ALV003 absent the experimental compounds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALV003 | Biological |
| ||
| ALV003 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Intestinal mucosal morphology | Intestinal mucosal morphology - change from baseline to week 6 | 6 weeks |
| Safety: Tolerability of ALV003 | Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype | Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6 | 6 weeks |
| Efficacy: Change in serological markers of celiac disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marja-Leena Lähdeaho, MD | FINN-MEDI Research Oy | Principal Investigator |
| Markku Mäki, MD, PhD | Tampere University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terveystalo Kuopio | Kuopio | Finland | ||||
| Oulu Diakonissalaitos (ODL) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24583059 | Derived | Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25. |
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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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| ID | Term |
|---|---|
| C571240 | ALV003 |
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Serological markers of celiac disease - change from baseline to week 6
| 6 weeks |
| Oulu |
| Finland |
| FINN-MEDI Research Oy - Clinical Trials Center | Tampere | Finland |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |