Trial Outcomes & Findings for Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis (NCT NCT03824405)
NCT ID: NCT03824405
Last Updated: 2022-10-25
Results Overview
Investigator's Global Assessment (IGA) success defined as an IGA score of "Clear" (0) or "Almost Clear" (1) with at least a 2-grade improvement
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Day 85
Results posted on
2022-10-25
Participant Flow
Participant milestones
| Measure |
BTX 1204
BTX 1204 twice daily
BTX 1204: BTX 1204 liquid formulation
|
Vehicle
Vehicle twice daily
Vehicle: Vehicle liquid formulation
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
65
|
55
|
|
Overall Study
NOT COMPLETED
|
35
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
BTX 1204
n=99 Participants
BTX 1204 twice daily
BTX 1204: BTX 1204 liquid formulation
|
Vehicle
n=95 Participants
Vehicle twice daily
Vehicle: Vehicle liquid formulation
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment
1 - Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment
2 - Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment
3 - Moderate
|
99 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Investigator Global Assessment
4 - Severe
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 85Population: ITT Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the ITT Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 5 (5.0) Reason for Exclusion from the ITT Population, n (%) Not At Least One Post-Baseline Efficacy Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 5 (5.0)
Investigator's Global Assessment (IGA) success defined as an IGA score of "Clear" (0) or "Almost Clear" (1) with at least a 2-grade improvement
Outcome measures
| Measure |
BTX 1204
n=99 Participants
BTX 1204 twice daily
BTX 1204: BTX 1204 liquid formulation
|
Vehicle
n=95 Participants
Vehicle twice daily
Vehicle: Vehicle liquid formulation
|
|---|---|---|
|
Investigator's Global Assessment (IGA)
Success
|
12 Participants
|
18 Participants
|
|
Investigator's Global Assessment (IGA)
Failure
|
87 Participants
|
77 Participants
|
Adverse Events
BTX 1204
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BTX 1204
n=99 participants at risk
BTX 1204 twice daily
BTX 1204: BTX 1204 liquid formulation
|
Vehicle
n=98 participants at risk
Vehicle twice daily
Vehicle: Vehicle liquid formulation
|
|---|---|---|
|
General disorders
Post-procedural complication
|
1.0%
1/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
0.00%
0/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
0.00%
0/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
Other adverse events
| Measure |
BTX 1204
n=99 participants at risk
BTX 1204 twice daily
BTX 1204: BTX 1204 liquid formulation
|
Vehicle
n=98 participants at risk
Vehicle twice daily
Vehicle: Vehicle liquid formulation
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
11.1%
11/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
15.3%
15/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
7/99 • Number of events 7 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
1.0%
1/98 • Number of events 1 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
|
Skin and subcutaneous tissue disorders
Nasopharyngitis
|
6.1%
6/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
1.0%
1/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
|
Skin and subcutaneous tissue disorders
Application Site Pain
|
4.0%
4/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
2.0%
2/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.0%
3/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
3.1%
3/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
|
Skin and subcutaneous tissue disorders
Application Site Reaction
|
3.0%
3/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
2.0%
2/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.0%
3/99 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
1.0%
1/98 • 85 days
Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee As Study is a Multi-centre Study, no Publication of the Study results may be made until Publication of the results of the Multi-centre study or 2 years after Study Completion, whichever is sooner.
- Publication restrictions are in place
Restriction type: OTHER