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The closure of the study is driven by the decision to redesign the study protocol for future studies.
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The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT-11 low | Experimental | Oral |
|
| BT-11 high | Experimental | Oral |
|
| Placebo | Placebo Comparator | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-11 low | Drug | Oral |
| |
| BT-11 high |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs | 12 Weeks |
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No patients enrolled
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
Oral |
|
| Placebo | Drug | Oral |
|
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |