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| Name | Class |
|---|---|
| Veristat, Inc. | OTHER |
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The purpose of this study is to evaluate and compare the efficacy of B244 in treating patients with hypertension.
This is a Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 4 weeks vs vehicle application on BP and inflammatory biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B244 4 pumps applied to the face | Active Comparator | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. |
|
| B 244 8 Pumps applied to face and torso | Active Comparator | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. |
|
| Vehicle 4 pumps applied to the face | Sham Comparator | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. |
|
| Vehicle 8 pumps applied to face and torso | Sham Comparator | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B244 | Biological | odorless suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration. | Baseline-6 weeks |
| Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups | Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28. | Baseline-Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group | Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Inflammatory Biomarkers Between Active and Vehicle Groups | To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers. | Baseline-Week 4 |
| Microbial Content |
Inclusion Criteria:
Male and female subjects ≥18 years of age
In good general health as determined by a thorough medical history and physical examination, and vital signs
Clinical diagnosis of elevated Blood Pressure defined as:
Hypertension treatment naïve patients, defined as those patients who have never been treated with antihypertensive medications or have been off any hypertensive treatment for a period of 12 weeks or longer.
Willing to refrain from using any antihypertensive treatments, other than the investigational product, including herbal supplements, systemic use of steroids, chronic use of NSAIDS, any antihypertensive agents, such as beta-blockers, diuretics, ACE inhibitors, CA channel blockers, Alpha blockers, Central Acting agents and vasodilators.
Ability to comprehend and comply with procedures
Agree to commit to participate in the current protocol
Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Weiss, MD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates | Birmingham | Alabama | 35205 | United States | ||
| Elite Clinical Studies |
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| ID | Title | Description |
|---|---|---|
| FG000 | B244 4 Pumps Applied to the Face | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. B244: odorless suspension, 8x10E9 cells/mL |
| FG001 | B 244 8 Pumps Applied to Face and Torso |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2016 | Jul 19, 2022 |
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| Vehicle | Biological | odorless suspension |
|
| Baseline-Week 4 |
| Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure | An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements. | Baseline-Week 4 |
Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
| Baseline, Day 28, Day 42 |
| Microbial Composition | Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples. | Baseline, Day 28, Day 42 |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Clinical Research Consulting | Milford | Connecticut | 06460 | United States |
| AGA Clinical Trials | Hialeah | Florida | 33012 | United States |
| ICCT Research International | Chicago | Illinois | 60611 | United States |
| MedPharmics | Metairie | Louisiana | 70006 | United States |
| Alternative Primary Care (Einstein Clinical Research) | Silver Spring | Maryland | 20190 | United States |
| CHEAR Center | The Bronx | New York | 10459 | United States |
| Research Trials WorldWide | Humble | Texas | 77338 | United States |
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. B244: odorless suspension, 8x10E9 cells/mL |
| FG002 | Vehicle 4 Pumps Applied to the Face | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. Vehicle: odorless suspension |
| FG003 | Vehicle 8 Pumps Applied to Face and Torso | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. Vehicle: odorless suspension |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent to Treat Population (ITT): All randomized subjects, analyzed according to treatment assigned.
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| ID | Title | Description |
|---|---|---|
| BG000 | B244 4 Pumps Applied to the Face | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. B244: odorless suspension, 8x10E9 cells/mL |
| BG001 | B 244 8 Pumps Applied to Face and Torso | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. B244: odorless suspension, 8x10E9 cells/mL |
| BG002 | Vehicle 4 Pumps Applied to the Face | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. Vehicle: odorless suspension |
| BG003 | Vehicle 8 Pumps Applied to Face and Torso | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. Vehicle: odorless suspension |
| BG004 | 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, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| BMI Category | Count of Participants | Participants |
| ||||||||||||||||
| Smoking History | 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 | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration. | Safety Population: All subjects who received at least 1 dose of study medication. Subjects were to be analyzed according to the study drug received. | Posted | Count of Participants | Participants | Baseline-6 weeks |
|
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| ||||||||||||||||||||||||||||||||||
| Primary | Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups | Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28. | Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4. | Posted | Least Squares Mean | Standard Deviation | mmHg | Baseline-Week 4 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group | Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28. | Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4. | Posted | Least Squares Mean | Standard Deviation | mmHg | Baseline-Week 4 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure | An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements. | Ambulatory Blood Pressure Monitoring Population (ABPP): Subjects in the Safety Population who had valid baseline and Day 28 ambulatory BP monitoring (ABPM) measurements. Subjects who repeated the ABPM were to be included in the population if the repeated assessment met the device monitor's criteria for "passing". | Posted | Mean | Standard Deviation | mmHg | Baseline-Week 4 |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference in Inflammatory Biomarkers Between Active and Vehicle Groups | To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers. | Intent to Treat Population (ITT): All randomized subjects, analyzed according to treatment assigned. | Posted | Mean | Standard Deviation | units on a scale | Baseline-Week 4 |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Microbial Content | Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples. | Data was not collected for this exploratory endpoint. | Posted | Baseline, Day 28, Day 42 |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Microbial Composition | Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples. | Data was not collected for this exploratory endpoint. | Posted | Baseline, Day 28, Day 42 |
|
Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
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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 | B244 4 Pumps Applied to the Face | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. B244: odorless suspension, 8x10E9 cells/mL | 0 | 33 | 0 | 33 | 4 | 33 |
| EG001 | B 244 8 Pumps Applied to Face and Torso | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. B244: odorless suspension, 8x10E9 cells/mL | 0 | 33 | 1 | 33 | 6 | 33 |
| EG002 | Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps) | 4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks. Vehicle: odorless suspension | 0 | 66 | 0 | 66 | 11 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of depression | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Systematic Assessment |
| ||
| Glycosylated haemoglobin increased | Investigations | Systematic Assessment |
| ||
| Weight increased | Investigations | Systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
|
Sponsor shall have 45 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional one hundred twenty (120) days to enable Sponsor to seek patent protections.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hyun Kim, Vice President Clinical Operations | AOBiome Therapeutics | 617-639-9980 | hkim@aobiome.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2017 | Jul 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058246 | Prehypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ≥60 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| ≥30 kg/m^2 |
|
| Former |
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| Current |
|
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4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
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4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
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