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| ID | Type | Description | Link |
|---|---|---|---|
| U44AI134590 | U.S. NIH Grant/Contract | View source |
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Due to low enrollment related to Covid.
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.
This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latiglutenase | Active Comparator | IMGX003 |
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| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latiglutenase | Drug | Administered orally (daily) |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity Reduction | The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-I health survey relative to placebo. | 6 months |
| Health Related Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Murray, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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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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A two-period crossover design will be used where the two possible treatment sequences will be assigned at random.
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The PI, CRA and study biostatistician will be masked until database lock.
| Placebo | Other | Administered orally (daily) |
|
A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-S health survey relative to placebo. |
| 6 months |
| Health Related Quality of Life | A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by ICDSQ health survey relative to placebo. | 6 months |
| Health Related Quality of Life | A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by SF-12 health survey relative to placebo. | 6 months |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |