Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT-11 low-dose (440 mg) | Experimental | Oral, once daily tablet |
|
| BT-11 high-dose (880 mg) | Experimental | Oral, once daily tablet |
|
| Placebo | Placebo Comparator | Oral, once daily tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-11 (440 mg) | Drug | Oral, once daily tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission | Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1. | Week 12 |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | United States | ||
| Ventura Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BT-11 Low-dose (440 mg) | Oral, once daily tablet |
| FG001 | BT-11 High-dose (880 mg) | Oral, once daily tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Nov 3, 2020 |
Not provided
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Not provided
Not provided
Not provided
| BT-11 (880 mg) |
| Drug |
Oral, once daily tablet |
|
| Placebo | Drug | Oral, once daily tablet |
|
| Ventura |
| California |
| 93003 |
| United States |
| Clinical Research of California | Walnut Creek | California | 94598 | United States |
| Medycal Research Inc. | Brooksville | Florida | 34613 | United States |
| Invesclinic.U.S,LLC.FL | Fort Lauderdale | Florida | 33308 | United States |
| I.H.S Health LLC | Kissimmee | Florida | 34741 | United States |
| Smart Medical Research | Richmond Hill | New York | 11102 | United States |
| Invesclinic.U.S,LLC. | McAllen | Texas | 78503 | United States |
| Texas Gastroenterology Associates | Spring | Texas | 77386 | United States |
| Polyclinic and Daily hospital "Dr Al Tawil" | Sarajevo | Federation BiH | 71000 | Bosnia and Herzegovina |
| Cantonal Hospital Zenica, Gastroenterology | Zenica | 72000 | Bosnia and Herzegovina |
| Polyclinic Duvnjak | Zagreb | 10000 | Croatia |
| RIVERM E D Sp. zo.o. | Poznan | Greater Poland Voivodeship | 61441 | Poland |
| Centrum Badan Klinicznych PI-House Sp. z o.o. | Gdansk | Pomeranian Voivodeship | 80546 | Poland |
| Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv | Kharkiv | 61172 | Ukraine |
| Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon | Odesa | 65082 | Ukraine |
| FG002 |
| Placebo |
Oral, once daily tablet |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BT-11 Low-dose (440 mg) | Oral, once daily tablet |
| BG001 | BT-11 High-dose (880 mg) | Oral, once daily tablet |
| BG002 | Placebo | Oral, once daily tablet |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1. | ITT | Posted | Number | percentage of participants | Week 12 |
|
|
|
15 months
Not provided
Not provided
| 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 Low-dose (440 mg) | Oral, once daily tablet | 0 | 66 | 2 | 66 | 23 | 66 |
| EG001 | BT-11 High-dose (880 mg) | Oral, once daily tablet | 0 | 66 | 3 | 66 | 29 | 66 |
| EG002 | Placebo | Oral, once daily tablet | 0 | 66 | 3 | 66 | 27 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Proctitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Amoebiasis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia Viral | Infections and infestations | Systematic Assessment |
| ||
| Foot Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Coronavirus Test Positive | Investigations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Colitis Ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Corona Virus Infection | Infections and infestations | Systematic Assessment |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development | NImmune Biopharma, Inc. | (540) 218-2262 | info@nimmunebio.com |
| Mar 31, 2023 |
| Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|