Trial Outcomes & Findings for A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis (NCT NCT03775434)
NCT ID: NCT03775434
Last Updated: 2024-08-05
Results Overview
Pulse rate (beats per minute \[bpm\]) will be obtained. Clinical significance of pulse rate will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2024-08-05
Participant Flow
Participant milestones
| Measure |
B244
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
B244
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
B244
n=28 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Age, Customized
|
7.4 years
STANDARD_DEVIATION 4.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Percentage of Total Body Surface Area Affected by Atopic Dermatitis
|
17.98 % of total body surface area
STANDARD_DEVIATION 7.581 • n=5 Participants
|
|
Baseline vIGA-AD Score
2=Mild
|
11 Participants
n=5 Participants
|
|
Baseline vIGA-AD Score
3=Moderate
|
17 Participants
n=5 Participants
|
|
Weight
|
36.22 kg
STANDARD_DEVIATION 30.599 • n=5 Participants
|
|
Height
|
124.0 cm
STANDARD_DEVIATION 29.95 • n=5 Participants
|
|
BMI
|
20.5 kg/m^2
STANDARD_DEVIATION 7.73 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: ITT population: All subjects who were enrolled and took at least 1 dose of study treatment.
Safety and tolerability endpoints will consist of all adverse events reporting from Baseline to Day 28.
Outcome measures
| Measure |
B244
n=28 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)as Assessed by CTCAE v4.0
|
11 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Intent to Treat (ITT) population (all subjects who were enrolled and took at least 1 dose of study treatment) that remained in the study at Day 28.
A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT \[Head, eyes, ears, nose, throat\], Lymphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremities, and other). Clinical significance of the physical exam will be determined at investigator's discretion. Results for each system were assessed as Normal, Abnormal CS (clinically significant), or Abnormal NCS (not clinically significant) and shift was analyzed from Baseline to Day 28.
Outcome measures
| Measure |
B244
n=25 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Cardiovascular: Normal -> Normal
|
25 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Dermatological: Normal -> Abnormal CS
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Dermatological: Normal -> Normal
|
24 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Extremities: Normal -> Normal
|
25 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Gastrointestinal: Normal -> Normal
|
25 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
General Appearance: Abnormal NCS -> Abnormal NCS
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
General Appearance: Normal -> Normal
|
24 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
HEENT: Abnormal CS-> Normal
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
HEENT: Normal -> Normal
|
24 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Lymphatic: Normal -> Normal
|
25 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Musculoskeletal: Normal -> Normal
|
25 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Neurological: Normal -> Normal
|
25 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Respiratory: Normal -> Abnormal NCS
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Respiratory: Normal -> Normal
|
24 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Thyroid: Missing -> Normal
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Thyroid: Normal -> Normal
|
24 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Intent to Treat (ITT) population (all subjects who were enrolled and took at least 1 dose of study treatment) that remained in the study at Day 28.
Blood pressure will be obtained (mmHg). Clinical significance of blood pressure will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Outcome measures
| Measure |
B244
n=25 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Mean Change in Blood Pressure From Baseline at Day 28
Diastolic Blood Pressure
|
1.6 mmHg
Standard Deviation 9.3
|
|
Mean Change in Blood Pressure From Baseline at Day 28
Systolic Blood Pressure
|
1.8 mmHg
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Intent to Treat (ITT) population (all subjects who were enrolled and took at least 1 dose of study treatment) that remained in the study at Day 28.
Pulse rate (beats per minute \[bpm\]) will be obtained. Clinical significance of pulse rate will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Outcome measures
| Measure |
B244
n=25 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Mean Change in Pulse Rate From Baseline at Day 28
|
3.9 bpm
Standard Deviation 15.3
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Intent to Treat (ITT) population (all subjects who were enrolled and took at least 1 dose of study treatment) that remained in the study at Day 28.
Body temperature (°C) will be obtained. Clinical significance of body temperature will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Outcome measures
| Measure |
B244
n=25 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Mean Change in Body Temperature From Baseline at Day 28
|
-0.2 °C
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Days 7, 14, 21, and 28Population: Subjects from the Intent to Treat (ITT) population (all subjects who were enrolled and took at least 1 dose of study treatment) that remained in the study at each respective visit day.
The vIGA-AD is a physician assessment ranking of Atopic Dermatitis symptoms from 0-clear, to 4- severe.
Outcome measures
| Measure |
B244
n=28 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · -2 - Improved by 2 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · -3 - Improved by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · -4 - Improved by 4 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · -1 - Improved by 1 grade
|
5 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · 4 - Worsen by 4 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · 3 - Worsen by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · 2 - Worsen by 2 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · 1 - Worsen by 1 grade
|
2 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · No change
|
23 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 7 · -1 - Improved by 1 grade
|
1 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · 4 - Worsen by 4 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · 3 - Worsen by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · 2 - Worsen by 2 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · 1 - Worsen by 1 grade
|
2 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · No change
|
20 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · -1 - Improved by 1 grade
|
3 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · -2 - Improved by 2 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · -3 - Improved by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 14 · -4 - Improved by 4 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · 4 - Worsen by 4 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · 3 - Worsen by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · 2 - Worsen by 2 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · 1 - Worsen by 1 grade
|
2 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · No change
|
17 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · -1 - Improved by 1 grade
|
6 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · -2 - Improved by 2 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · -3 - Improved by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 21 · -4 - Improved by 4 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · 4 - Worsen by 4 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · 3 - Worsen by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · 2 - Worsen by 2 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · 1 - Worsen by 1 grade
|
2 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · No change
|
17 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · -2 - Improved by 2 grades
|
1 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · -3 - Improved by 3 grades
|
0 Participants
|
|
Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
Change from Baseline on Day 28 · -4 - Improved by 4 grades
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Days 7, 14, 21, and 28Population: Subjects from the Intent to Treat (ITT) population (all subjects who were enrolled and took at least 1 dose of study treatment) that remained in the study at each respective visit day.
EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
Outcome measures
| Measure |
B244
n=28 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Changes in Area Severity Index (EASI) Score.
Change from Baseline to Day 7
|
-0.31 score on a scale
Standard Deviation 2.920
|
|
Changes in Area Severity Index (EASI) Score.
Change from Baseline to Day 14
|
-1.30 score on a scale
Standard Deviation 4.088
|
|
Changes in Area Severity Index (EASI) Score.
Change from Baseline to Day 21
|
-1.98 score on a scale
Standard Deviation 4.693
|
|
Changes in Area Severity Index (EASI) Score.
Change from Baseline to Day 28
|
-2.31 score on a scale
Standard Deviation 4.109
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Days 7, 14, 21, and 28Population: ITT population: All subjects who were enrolled and took at least 1 dose of study treatment.
POEM is a survey that consists of 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points based on frequency of occurrence during the prior week (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days). A higher total score indicates a higher severity of disease (0 \[clear\] to 28 \[very severe\]).
Outcome measures
| Measure |
B244
n=28 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Changes in Patient Oriented Eczema Measure (POEM Total Score).
Change from Baseline to Day 7
|
-1.2 score on a scale
Standard Deviation 4.68
|
|
Changes in Patient Oriented Eczema Measure (POEM Total Score).
Change from Baseline to Day 14
|
-4.2 score on a scale
Standard Deviation 5.21
|
|
Changes in Patient Oriented Eczema Measure (POEM Total Score).
Change from Baseline to Day 21
|
-4.4 score on a scale
Standard Deviation 6.10
|
|
Changes in Patient Oriented Eczema Measure (POEM Total Score).
Change from Baseline to Day 28
|
-4.2 score on a scale
Standard Deviation 7.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Days 7, 14, 21, and 28Population: ITT population: All subjects who were enrolled and took at least 1 dose of study treatment.
The Burn Man Itch Scale is used as a self report tool for subjects to indicate how itchy the area of atopic dermatitis feels at the timepoints during the study. It's reported on a scale between 0-comfortable, no itch and 4-Itches most terribly; impossible to sit still; concentrate.
Outcome measures
| Measure |
B244
n=28 Participants
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Changes in Patient Reported Outcome (Self-reported ItchMan Scale).
Change from Baseline to Day 7
|
-0.2 score on a scale
Standard Deviation 0.92
|
|
Changes in Patient Reported Outcome (Self-reported ItchMan Scale).
Change from Baseline to Day 14
|
-0.8 score on a scale
Standard Deviation 1.20
|
|
Changes in Patient Reported Outcome (Self-reported ItchMan Scale).
Change from Baseline to Day 21
|
-0.6 score on a scale
Standard Deviation 1.26
|
|
Changes in Patient Reported Outcome (Self-reported ItchMan Scale).
Change from Baseline to Day 28
|
-0.8 score on a scale
Standard Deviation 1.40
|
Adverse Events
B244
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
B244
n=28 participants at risk
B244 suspension in 30ml/bottle.
B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
General disorders
Malaise
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Infections and infestations
Localized infection
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
2/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
2/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
3.6%
1/28 • Baseline to Day 28
All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
|
Additional Information
Hyun Kim, Vice President Clinical Operations
AOBiome Therapeutics
Phone: 617-639-9980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall have 60 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 90 days to enable Sponsor to seek patent protections.
- Publication restrictions are in place
Restriction type: OTHER