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Decision of Landos Biopharma (not related to safety or efficacy)
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This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT-11 880 mg | Experimental | Oral once daily tablet |
|
| Placebo | Placebo Comparator | Oral once daily tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-11 880 mg | Drug | Oral once daily tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission Rate | Clinical remission defined by CDAI score <150. | 12 weeks |
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Key Inclusion Criteria:
Key exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Center | Tampa | Florida | 33592 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BT-11 880 mg | Oral once daily tablet BT-11 880 mg: Oral once daily tablet |
| FG001 | Placebo | Oral once daily tablet Placebo: Oral once daily tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BT-11 880 mg | Oral once daily tablet BT-11 880 mg: Oral once daily tablet |
| BG001 | Placebo | Oral once daily tablet Placebo: Oral once daily tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Remission Rate | Clinical remission defined by CDAI score <150. | Posted | Count of Participants | Participants | 12 weeks |
|
|
30 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BT-11 880 mg | Oral once daily tablet BT-11 880 mg: Oral once daily tablet | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and Infestations | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Management | NImmune | (540) 944-4545 | pm@nimmun.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2021 | Nov 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Crohn's Disease (SES-CD) SCORED ≥ 6 (≥ 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period.
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| Drug |
Oral once daily tablet |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | Placebo | Oral once daily tablet Placebo: Oral once daily tablet | 0 | 11 | 0 | 11 | 7 | 11 |
| Other | General disorders | Non-systematic Assessment |
|
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| D007410 | Intestinal Diseases |