Trial Outcomes & Findings for The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis (NCT NCT05295732)
NCT ID: NCT05295732
Last Updated: 2025-11-17
Results Overview
Comparison of proportions of subjects in percentages with ≥2-point changes from Baseline in Investigator Global Assessment (IGA)-scaling and fissuring scores in the Treatment Area at Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
153 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-11-17
Participant Flow
The study was conducted in 34 sites across the United States, Canada, Germany, France, and Italy enrolled subjects, and 33 of these sites randomized subjects.
Participant milestones
| Measure |
TMB-001 0.05%
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
TMB-001 0.05% QD
At Week 12, TMB-001 0.05% BID treatment responders (who had achieved a ≥1-point reduction in IGA score from baseline) were re-randomized (1:1 ratio) to 12 weeks of open-label treatment with TMB-001 0.05% BID or TMB-001 0.05% QD. Subjects with less than a 1-point reduction in IGA score from baseline were discontinued from the study. Vehicle-treated subjects who achieved \<1-point reduction in IGA score from baseline by week 12, were eligible to cross over to 12 weeks of open-label treatment with TMB-001 0.05% BID treatment. Subjects with a ≥1-point reduction in IGA score from baseline on vehicle were discontinued from the study.
|
TMB-001 0.05% BID
At Week 12, TMB-001 0.05% BID treatment responders (who had achieved a ≥1-point reduction in IGA score from baseline) were re-randomized (1:1 ratio) to 12 weeks of open-label treatment with TMB-001\> 0.05% BID or TMB-001 0.05% QD. Subjects with less than a 1-point reduction in IGA score from baseline were discontinued from the study. Vehicle-treated subjects who achieved \<1-point reduction in IGA score from baseline by week 12, were eligible to cross over to 12 weeks of open-label treatment with TMB-001 0.05% BID treatment. Subjects with a ≥1-point reduction in IGA score from baseline on vehicle were discontinued from the study.
|
Maximal Use
The optional maximal use arm part of the trial was conducted under the same protocol number for operational reasons, but with separate design, objective, and patients. Adult and pediatric subjects, at a subset of preselected centers, were enrolled in an open-label Optional Maximal Use Arm to evaluate the systemic exposure and safety of TMB-001 0.05% for the treatment of congenital ichthyosis under maximal use conditions. Initially, adult and pediatric subjects with congenital ichthyosis were dosed for 14 days with TMB-001 0.05% BID. Following an interim pharmacokinetic (PK) analysis and based on the exposure data for subjects aged ≥12 years, pediatric subjects aged 6 to 11 years began dosing with TMB-001 0.05% BID for 14\> days. Following the 14-day PK assessment period, subjects received TMB-001 0.05% BID treatment for 10 weeks to provide additional safety and limited efficacy data.
|
|---|---|---|---|---|---|
|
Phase 3: Double-blind / MUsT: Treatment
STARTED
|
79
|
40
|
0
|
0
|
34
|
|
Phase 3: Double-blind / MUsT: Treatment
Dosed
|
78
|
38
|
0
|
0
|
34
|
|
Phase 3: Double-blind / MUsT: Treatment
COMPLETED
|
65
|
36
|
0
|
0
|
32
|
|
Phase 3: Double-blind / MUsT: Treatment
NOT COMPLETED
|
14
|
4
|
0
|
0
|
2
|
|
Phase 3: Open-label / MUsT: Maintenance
STARTED
|
0
|
0
|
28
|
38
|
32
|
|
Phase 3: Open-label / MUsT: Maintenance
COMPLETED
|
0
|
0
|
28
|
37
|
31
|
|
Phase 3: Open-label / MUsT: Maintenance
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
TMB-001 0.05%
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
TMB-001 0.05% QD
At Week 12, TMB-001 0.05% BID treatment responders (who had achieved a ≥1-point reduction in IGA score from baseline) were re-randomized (1:1 ratio) to 12 weeks of open-label treatment with TMB-001 0.05% BID or TMB-001 0.05% QD. Subjects with less than a 1-point reduction in IGA score from baseline were discontinued from the study. Vehicle-treated subjects who achieved \<1-point reduction in IGA score from baseline by week 12, were eligible to cross over to 12 weeks of open-label treatment with TMB-001 0.05% BID treatment. Subjects with a ≥1-point reduction in IGA score from baseline on vehicle were discontinued from the study.
|
TMB-001 0.05% BID
At Week 12, TMB-001 0.05% BID treatment responders (who had achieved a ≥1-point reduction in IGA score from baseline) were re-randomized (1:1 ratio) to 12 weeks of open-label treatment with TMB-001\> 0.05% BID or TMB-001 0.05% QD. Subjects with less than a 1-point reduction in IGA score from baseline were discontinued from the study. Vehicle-treated subjects who achieved \<1-point reduction in IGA score from baseline by week 12, were eligible to cross over to 12 weeks of open-label treatment with TMB-001 0.05% BID treatment. Subjects with a ≥1-point reduction in IGA score from baseline on vehicle were discontinued from the study.
|
Maximal Use
The optional maximal use arm part of the trial was conducted under the same protocol number for operational reasons, but with separate design, objective, and patients. Adult and pediatric subjects, at a subset of preselected centers, were enrolled in an open-label Optional Maximal Use Arm to evaluate the systemic exposure and safety of TMB-001 0.05% for the treatment of congenital ichthyosis under maximal use conditions. Initially, adult and pediatric subjects with congenital ichthyosis were dosed for 14 days with TMB-001 0.05% BID. Following an interim pharmacokinetic (PK) analysis and based on the exposure data for subjects aged ≥12 years, pediatric subjects aged 6 to 11 years began dosing with TMB-001 0.05% BID for 14\> days. Following the 14-day PK assessment period, subjects received TMB-001 0.05% BID treatment for 10 weeks to provide additional safety and limited efficacy data.
|
|---|---|---|---|---|---|
|
Phase 3: Double-blind / MUsT: Treatment
Various reasons
|
14
|
4
|
0
|
0
|
2
|
|
Phase 3: Open-label / MUsT: Maintenance
Various reasons
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis
Baseline characteristics by cohort
| Measure |
TMB-001 0.05%
n=78 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Maximal Use
n=34 Participants
The optional maximal use arm part of the trial was conducted under the same protocol number for operational reasons, but with separate design, objective, and patients. Adult and pediatric subjects, at a subset of preselected centers, were enrolled in an open-label Optional Maximal Use Arm to evaluate the systemic exposure and safety of TMB-001 0.05% for the treatment of congenital ichthyosis under maximal use conditions. Initially, adult and pediatric subjects with congenital ichthyosis were dosed for 14 days with TMB-001 0.05% BID. Following an interim pharmacokinetic (PK) analysis and based on the exposure data for subjects aged ≥12 years, pediatric subjects aged 6 to 11 years began dosing with TMB-001 0.05% BID for 14\> days. Following the 14-day PK assessment period, subjects received TMB-001 0.05% BID treatment for 10 weeks to provide additional safety and limited efficacy data.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
6 Participants
n=122 Participants
|
|
Age, Customized
Age · 6-11 years
|
16 Participants
n=202 Participants
|
8 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
33 Participants
n=122 Participants
|
|
Age, Customized
Age · 12-16 years
|
19 Participants
n=202 Participants
|
8 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
34 Participants
n=122 Participants
|
|
Age, Customized
Age · >=17 years
|
43 Participants
n=202 Participants
|
22 Participants
n=283 Participants
|
18 Participants
n=120 Participants
|
83 Participants
n=122 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=202 Participants
|
15 Participants
n=283 Participants
|
16 Participants
n=120 Participants
|
60 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=202 Participants
|
23 Participants
n=283 Participants
|
18 Participants
n=120 Participants
|
90 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=202 Participants
|
19 Participants
n=283 Participants
|
25 Participants
n=120 Participants
|
72 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
48 Participants
n=202 Participants
|
17 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
72 Participants
n=122 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
8 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
14 Participants
n=122 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=202 Participants
|
25 Participants
n=283 Participants
|
21 Participants
n=120 Participants
|
103 Participants
n=122 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
23 Participants
n=122 Participants
|
|
Body Mass Index (BMI)
|
22.903 kg/m^2
STANDARD_DEVIATION 5.4218 • n=202 Participants
|
24.092 kg/m^2
STANDARD_DEVIATION 7.6000 • n=283 Participants
|
24.468 kg/m^2
STANDARD_DEVIATION 8.6960 • n=120 Participants
|
23.559 kg/m^2
STANDARD_DEVIATION 6.8388 • n=122 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: For the primary efficacy endpoint, missing Week 12 IGA scores were imputed by a multiple imputation approach and IGA responder status was derived from the imputed values. The analysis was then performed on each of the 50 imputed datasets. The final proportion of responders is the average proportion across all 50 imputed datasets hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportions of subjects in percentages with ≥2-point changes from Baseline in Investigator Global Assessment (IGA)-scaling and fissuring scores in the Treatment Area at Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=78 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Investigator Global Assessment (IGA) Score
|
41.4 percentage of responders
|
44.9 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportion of subjects in percentages with IGA scores of clear or almost clear at Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=78 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Number of Subjects With IGA Scores
|
35.8 percentage of responders
|
38.9 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is not available for 3 participants in the TMB-001 0.05% group and for 2 participants in the vehicle group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportion of subjects in percentages who achieve IGA-scaling severity sub-score improvement ≥ 2-points from Baseline to Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=75 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=36 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in IGA-scaling Severity Sub-score
|
40.4 percentage of responders
|
36.4 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is not available for 59 participants in the TMB-001 0.05% group and for 29 participants in the vehicle group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportion of subjects in percentages with ≥4-point improvement from baseline in Worst Itch-QoL scores at Week 12 in subjects with baseline WI-NRS of ≥7 between TMB-001 0.05% and vehicle-treated subjects. Itch-Numeric Rating Scale (I-NRS) and Worst Itch-Numeric Rating Scale (WI-NRS) is an 0-10 scale where 0 is "no itching" and 10 is "worst itch imaginable".
Outcome measures
| Measure |
TMB-001 0.05%
n=19 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=9 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Worst Itch-Quality of Life (QoL) Scores
|
54.4 percentage of responders
|
68.7 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is not available for 4 participants in the TMB-001 0.05% group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportion of subjects in percentages who achieve 50% reduction from Baseline in VIIS-scaling scores at Week 12 in all areas with Baseline VIIS score ≥3 between TMB-001 0.05% and vehicle-treated subjects. Visual Index for Ichthyosis Severity Score is a 0-4 scale where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=74 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Visual Index of Ichthyosis Severity (VIIS) Score
|
47.2 percentage of responders
|
42.7 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is not available for 4 participants in the TMB-001 0.05% group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportion of subjects in percentages who achieve 25% reduction from Baseline in VIIS-scaling scores at Week 12 in all areas with Baseline VIIS score ≥3 between TMB-001 0.05% and vehicle-treated subjects. Visual Index for Ichthyosis Severity Score is a 0-4 scale where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=74 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in VIIS Score
|
71.3 percentage of responders
|
64.1 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is not available for 48 participants in the TMB-001 0.05% group and for 21 participants in the vehicle group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportion of subjects in percentages achieving ≥2 point improvement in IGA-fissuring severity sub-scores from Baseline to Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=30 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=17 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in IGA-fissuring Severity Sub-scores
|
54.1 percentage of responders
|
57.9 percentage of responders
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data reported for the re-randomized TMB-001 0.05% responders subjects in TMB-001 0.05% BID group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportions of subjects in percentages achieving ≥2-point improvement from Baseline in IGA scores at Week 24 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=28 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=27 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in IGA Score
|
57.1 percentage of responders
Interval 38.8 to 75.5
|
85.2 percentage of responders
Interval 71.8 to 98.6
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data reported for the re-randomized TMB-001 0.05% responders subjects in TMB-001 0.05% BID group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportion of subjects in percentages who achieve 50% reduction from Baseline in VIIS-scaling scores at Week 24 in all areas with Baseline VIIS score ≥3 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing. Visual Index for Ichthyosis Severity Score is a 0-4 scale where 0 is clear and 4 is severe.
Outcome measures
| Measure |
TMB-001 0.05%
n=28 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=27 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in VIIS Score
|
63.0 percentage of responders
Interval 44.7 to 81.2
|
85.2 percentage of responders
Interval 71.8 to 98.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is not available for 44 participants in the TMB-001 0.05% group and for 17 participants in the vehicle group.
Comparison of proportions of subjects in percentages with ≥11-point changes from Baseline in IQOL-32 scores at Week 12 between TMB-001 0.05% and vehicle-treated subjects. The IQoL-32 is a questionnaire containing 32, each scored from 0 to 4 ('not applicable', 'not at all', 'a little', 'a lot', 'tremendously') for a total score that varies between 0 and 128. A higher score, the higher impact on quality of life.
Outcome measures
| Measure |
TMB-001 0.05%
n=34 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=21 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Ichthyosis Quality of Life (IQoL)-32 Scores
|
47.1 percentage of responders
|
9.5 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is not available for 63 participants in the TMB-001 0.05% group and for 30 participants in the vehicle group.
Comparison of proportion of subjects in percentages with reduction from Baseline in DLQI ≥4 points at Week 12 between TMB-001 0.05% and vehicle-treated subjects in adult subjects with Baseline scores ≥11. The age-appropriate questionnaire contains 10 questions scored from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL).
Outcome measures
| Measure |
TMB-001 0.05%
n=15 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=8 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI) Scores
|
86.7 percentage of responders
|
37.5 percentage of responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only 5 pediatric subjects had Baseline scores of ≥13 in the TMB-001 0.05% group. No pediatric subjects had Baseline scores of ≥13 in the vehicle group.
Comparison of proportion of pediatric subjects in percentages with reduction from Baseline in CDLQI ≥4 points at Week 12 between TMB-001 0.05% and vehicle-treated subjects in pediatric subjects with Baseline scores of ≥13. The age-appropriate questionnaire contains 10 questions scored from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL).
Outcome measures
| Measure |
TMB-001 0.05%
n=5 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Children's Dermatology Life Quality Index (CDLQI) Scores
|
80.0 percentage of responders
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: No participants in the TMB-001 0.05% QD Group had Baseline I-NRS scores ≥7 and therefore, 0 participants in this Group were analyzed for this measure. Data is not available for 37 participants in the TMB-001 0.05% BID group.
Comparison of proportions of subjects in percentages with I-NRS improvement ≥4 points from Baseline in Itch-QoL scores (in subjects with Baseline I-NRS ≥7) at Week 24 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing.
Outcome measures
| Measure |
TMB-001 0.05%
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=1 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Itch-Quality of Life Scores - I-NRS
|
—
|
100 percentage of responders
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data is not available for 25 participants in the TMB-001 0.05% QD group and for 23 participants in the TMB-001 0.05% BID group. In addition, 11 participants in the TMB-001 0.05% BID group randomized to vehicle in the double-blinded period were not included. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.
Comparison of proportions of subjects in percentages with WI-NRS improvement ≥4 points from Baseline in Itch-QoL scores (in subjects with Baseline WI-NRS ≥7) at Week 24 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing.
Outcome measures
| Measure |
TMB-001 0.05%
n=3 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=4 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in Itch-Quality of Life Scores - WI-NRS
|
66.7 percentage of responders
Interval 0.0 to 100.0
|
75.0 percentage of responders
Interval 19.2 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data is not available for 24 participants in the TMB-001 0.05% QD group and for 23 participants in the TMB-001 0.05% BID group. In addition, 11 participants in the TMB-001 0.05% BID group randomized to vehicle in the double-blinded period were not included.
Comparison of proportions of adult subjects in percentages with DLQI changes of ≥4-point from Baseline scores (in subjects with Baseline scores ≥11) at Week 24 randomized to TMB-001 0.05% BID and QD maintenance dosing. The age-appropriate questionnaire contains 10 questions scored from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL).
Outcome measures
| Measure |
TMB-001 0.05%
n=4 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=4 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in DLQI Scores
|
75.0 percentage of responders
Interval 32.6 to 100.0
|
100 percentage of responders
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only 1 pediatric subjects had Baseline scores of ≥13 in the TMB-001 0.05% QD group, and 3 pediatric subjects had Baseline scores of ≥13 in the TMB-001 0.05% BID group.
Comparison of proportions of pediatric subjects in percentages with CDLQI changes of ≥4-point from Baseline scores (in subjects with Baseline scores ≥13) at Week 24 randomized to TMB-001 0.05% BID and QD maintenance dosing. The age-appropriate questionnaire contains 10 questions scored from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL).
Outcome measures
| Measure |
TMB-001 0.05%
n=1 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=3 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in CDLQI Scores
|
100 percentage of responders
Interval 100.0 to 100.0
|
100 percentage of responders
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data is not available for 18 participants in the TMB-001 0.05% QD group and for 17 participants in the TMB-001 0.05% BID group. In addition, 11 participants in the TMB-001 0.05% BID group randomized to vehicle in the double-blinded period were not included.
Proportions of subjects in percentages with ≥11-point change from Baseline in IQoL-32 at Week 24 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing in adult subjects. The IQoL-32 is a questionnaire containing 32, each scored from 0 to 4 ('not applicable', 'not at all', 'a little', 'a lot', 'tremendously') for a total score that varies between 0 and 128. A higher score, the higher impact on quality of life.
Outcome measures
| Measure |
TMB-001 0.05%
n=10 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=10 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Change in IQoL-32 Scores
|
40.0 percentage of responders
Interval 9.6 to 70.4
|
60.0 percentage of responders
Interval 29.6 to 90.4
|
SECONDARY outcome
Timeframe: 12 weeksComparison of proportion of subjects in percentages experiencing LSRs through Week 12 between TMB-001 0.05% and vehicle-treated subjects.
Outcome measures
| Measure |
TMB-001 0.05%
n=78 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
To Investigate the Proportion of Subjects Experiencing Local Skin Reactions (LSRs) With Topically Applied TMB-001 0.05% Ointment.
|
64.1 percentage of participants
Interval 52.4 to 74.7
|
36.8 percentage of participants
Interval 21.8 to 54.0
|
SECONDARY outcome
Timeframe: 12 weeksComparison of proportion of subjects in percentages experiencing TEAEs through Week 12 between TMB-001 0.05% and vehicle-treated subjects.
Outcome measures
| Measure |
TMB-001 0.05%
n=78 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
To Investigate the Proportion of Subjects Experiencing Treatment-emergent Adverse Events (TEAEs)
|
76.9 percentage of participants
|
63.2 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data reported for the re-randomized TMB-001 0.05% responders subjects in TMB-001 0.05% BID group.
Comparison of proportion of subjects in percentages experiencing LSRs through Week 24 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing.
Outcome measures
| Measure |
TMB-001 0.05%
n=28 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=27 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
To Investigate the Proportion of Subjects Experiencing LSRs With Topically Applied TMB-001 0.05% Ointment.
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data reported for the re-randomized TMB-001 0.05% responders subjects in TMB-001 0.05% BID group.
Comparison of proportion of subjects in percentages experiencing TEAEs through Week 24.
Outcome measures
| Measure |
TMB-001 0.05%
n=28 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=27 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
To Investigate the Proportion of Subjects Experiencing TEAEs
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
48.1 percentage of participants
Interval 28.7 to 68.1
|
SECONDARY outcome
Timeframe: Through week 12Comparison of proportion of subjects in percentages demonstrating clinically confirmed allergic contact dermatitis by patch testing through Week 12 between TMB-001 0.05% and vehicle-treated subjects.
Outcome measures
| Measure |
TMB-001 0.05%
n=78 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
n=38 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
To Investigate the Proportion of Subjects Demonstrating Clinically Confirmed Allergic Contact Dermatitis
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Data is not available for 24 participants in the Maximal use group.
maximal observed plasma concentration. \> Assessment of concentrations of isotretinoin, tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin.
Outcome measures
| Measure |
TMB-001 0.05%
n=10 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adults
Isotretinoin
|
4.13 ng/mL
Standard Deviation 6.48
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adults
4-Oxo-Isotretinoin
|
16.7 ng/mL
Standard Deviation 26
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adults
Tretinoin
|
0.04 ng/mL
Standard Deviation 0.12
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adults
4-oxo-tretinoin
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Data is not available for 32 participants in the Maximal use group.
maximal observed plasma concentration. \> Assessment of concentrations of isotretinoin, tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin.
Outcome measures
| Measure |
TMB-001 0.05%
n=2 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adolescents
4-oxo-tretinoin
|
3.60 ng/mL
Standard Deviation 5.08
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adolescents
Isotretinoin
|
7.7 ng/mL
Standard Deviation 1.17
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adolescents
4-Oxo-Isotretinoin
|
25.44 ng/mL
Standard Deviation 10.11
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Cmax After Multiple Dosing - Adolescents
Tretinoin
|
4.52 ng/mL
Standard Deviation 6.39
|
—
|
SECONDARY outcome
Timeframe: 0-24hrs after dosePopulation: Data is not available for 24 participants in the Maximal use group.
AUC0-24 = area under the curve over the first 24 hours post dose. \> Assessment of concentrations of isotretinoin, tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin.
Outcome measures
| Measure |
TMB-001 0.05%
n=10 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adults
Isotretinoin
|
78.44 hr*ng/mL
Standard Deviation 122.08
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adults
4-Oxo-Isotretinoin
|
352.95 hr*ng/mL
Standard Deviation 577.05
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adults
Tretinoin
|
0.17 hr*ng/mL
Standard Deviation 0.54
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adults
4-oxo-tretinoin
|
0.00 hr*ng/mL
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: 0-24hrs after dosePopulation: Data is not available for 32 participants in the Maximal use group.
AUC0-24 = area under the curve over the first 24 hours post dose. \> Assessment of concentrations of isotretinoin, tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin.
Outcome measures
| Measure |
TMB-001 0.05%
n=2 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adolescents
Isotretinoin
|
101.34 hr*ng/mL
Standard Deviation 61.15
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adolescents
4-Oxo-Isotretinoin
|
432.96 hr*ng/mL
Standard Deviation 121.81
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adolescents
Tretinoin
|
13.74 hr*ng/mL
Standard Deviation 19.43
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - AUC0-24 After Multiple Dosing - Adolescents
4-oxo-tretinoin
|
10.15 hr*ng/mL
Standard Deviation 14.35
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Data is not available for 24 participants in the Maximal use group.
Tmax = time to maximal plasma concentration. \> Assessment of concentrations of isotretinoin, tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin.
Outcome measures
| Measure |
TMB-001 0.05%
n=10 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adults
Isotretinoin
|
1.50 hours
Interval 0.0 to 24.0
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adults
4-Oxo-Isotretinoin
|
5 hours
Interval 0.0 to 24.0
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adults
Tretinoin
|
0.00 hours
Interval 0.0 to 6.0
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adults
4-oxo-tretinoin
|
0.00 hours
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Data is not available for 32 participants in the Maximal use group.
Tmax = time to maximal plasma concentration. \> Assessment of concentrations of isotretinoin, tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin.
Outcome measures
| Measure |
TMB-001 0.05%
n=2 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adolescents
Isotretinoin
|
14 hours
Interval 4.0 to 24.0
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adolescents
4-Oxo-Isotretinoin
|
18 hours
Interval 12.0 to 24.0
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adolescents
Tretinoin
|
2.00 hours
Interval 0.0 to 4.0
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Tmax After Multiple Dosing - Adolescents
4-oxo-tretinoin
|
1.00 hours
Interval 0.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Data is not available for 27 participants in the Maximal use group.
Assessment of concentrations of isotretinoin, tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin.
Outcome measures
| Measure |
TMB-001 0.05%
n=7 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Steady State Concentration After Multiple Dosing - Children
Isotretinoin
|
1.27 ng/mL
Standard Deviation 1.2
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Steady State Concentration After Multiple Dosing - Children
4-Oxo-Isotretinoin
|
9.53 ng/mL
Standard Deviation 6.13
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Steady State Concentration After Multiple Dosing - Children
Tretinoin
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Maximal Use Arm: Isotretinoin, Tretinoin, 4-oxo-tretinoin and 4-oxo-isotretinoin - Steady State Concentration After Multiple Dosing - Children
4-oxo-tretinoin
|
0 ng/mL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 12 weeksLocal skin reactions (burnings/stinging, erythema, erosions and edema) are reported as LSRs.
Outcome measures
| Measure |
TMB-001 0.05%
n=34 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Safety and Tolerability - LSRs
Erythema
|
16 events
|
—
|
|
Maximal Use Arm: Safety and Tolerability - LSRs
Erosions
|
7 events
|
—
|
|
Maximal Use Arm: Safety and Tolerability - LSRs
Edema
|
2 events
|
—
|
|
Maximal Use Arm: Safety and Tolerability - LSRs
Burning/stinging
|
17 events
|
—
|
SECONDARY outcome
Timeframe: 12 weeksLocal safety are reported as severe TEAEs related to treatment area.
Outcome measures
| Measure |
TMB-001 0.05%
n=34 Participants
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to TMB-001 0.05% QD with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12 week double-blind primary dosing period, the subjects continued with TMB-001 0.05% at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
Vehicle
In the first 3 weeks of the 12-week double-blind primary dosing period, subjects were randomized to Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™). For the last 9 weeks of the 12-week double-blind primary dosing period, the subjects continued with Vehicle at the increased dosing frequency of BID. Mandatory bland emollient was discontinued.
|
|---|---|---|
|
Maximal Use Arm: Safety and Tolerability - TEAEs
Pruritus
|
2 events
|
—
|
|
Maximal Use Arm: Safety and Tolerability - TEAEs
Administration site reactions
|
8 events
|
—
|
Adverse Events
Double-blinded Phase: TMB-001 0.05%
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Double-blinded Phase: Vehicle
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Open-label Phase: TMB-001 0.05% QD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Open-label Phase: TMB-001 0.05% BID
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Maximal Use
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blinded Phase: TMB-001 0.05%
n=78 participants at risk
Double-blinded phase: TMB-001 0.05% (N=78)
|
Double-blinded Phase: Vehicle
n=38 participants at risk
Double-blinded phase: Vehicle (N=38)
|
Open-label Phase: TMB-001 0.05% QD
n=28 participants at risk
Open-label phase: TMB-001 0.05% QD (N=28)
|
Open-label Phase: TMB-001 0.05% BID
n=38 participants at risk
Open-label phase: TMB-001 0.05% BID (N=38)
|
Maximal Use
n=34 participants at risk
Maximal use (N=34)
|
|---|---|---|---|---|---|
|
Infections and infestations
Viral rash
|
1.3%
1/78 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/34 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
Other adverse events
| Measure |
Double-blinded Phase: TMB-001 0.05%
n=78 participants at risk
Double-blinded phase: TMB-001 0.05% (N=78)
|
Double-blinded Phase: Vehicle
n=38 participants at risk
Double-blinded phase: Vehicle (N=38)
|
Open-label Phase: TMB-001 0.05% QD
n=28 participants at risk
Open-label phase: TMB-001 0.05% QD (N=28)
|
Open-label Phase: TMB-001 0.05% BID
n=38 participants at risk
Open-label phase: TMB-001 0.05% BID (N=38)
|
Maximal Use
n=34 participants at risk
Maximal use (N=34)
|
|---|---|---|---|---|---|
|
General disorders
Application site erosion
|
17.9%
14/78 • Number of events 18 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.3%
2/38 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
10.5%
4/38 • Number of events 8 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
20.6%
7/34 • Number of events 7 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
General disorders
Application site erythema
|
34.6%
27/78 • Number of events 39 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
10.5%
4/38 • Number of events 4 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
17.9%
5/28 • Number of events 7 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
15.8%
6/38 • Number of events 14 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
32.4%
11/34 • Number of events 16 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
General disorders
Application site oedema
|
7.7%
6/78 • Number of events 7 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.6%
1/38 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.6%
1/38 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.9%
2/34 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
General disorders
Application site dermatitis
|
1.3%
1/78 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
3.6%
1/28 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.3%
2/38 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.9%
1/34 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
General disorders
Application site pain
|
29.5%
23/78 • Number of events 41 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
13.2%
5/38 • Number of events 6 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
14.3%
4/28 • Number of events 5 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
7.9%
3/38 • Number of events 10 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
38.2%
13/34 • Number of events 17 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
General disorders
Application site pruritus
|
15.4%
12/78 • Number of events 14 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
13.2%
5/38 • Number of events 7 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
14.7%
5/34 • Number of events 7 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
General disorders
Pyrexia
|
3.8%
3/78 • Number of events 3 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.6%
1/38 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
3.6%
1/28 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.9%
2/34 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Infections and infestations
COVID-19
|
1.3%
1/78 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
3.6%
1/28 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.3%
2/38 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/34 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/78 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.3%
2/38 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/34 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/78 • Number of events 3 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.3%
2/38 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
3.6%
1/28 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/34 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
4/78 • Number of events 5 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
7.9%
3/38 • Number of events 3 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
7.1%
2/28 • Number of events 3 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.6%
1/38 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.9%
1/34 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Nervous system disorders
Headache
|
9.0%
7/78 • Number of events 8 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.6%
1/38 • Number of events 3 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
7.9%
3/38 • Number of events 3 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
2.9%
1/34 • Number of events 1 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/78 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.3%
2/38 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/34 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
6/78 • Number of events 6 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/34 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
3/78 • Number of events 3 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.3%
2/38 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/28 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
0.00%
0/38 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
5.9%
2/34 • Number of events 2 • 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER