Trial Outcomes & Findings for Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas (NCT NCT02828111)
NCT ID: NCT02828111
Last Updated: 2019-01-08
Results Overview
All serious adverse events (SAEs) and all other non-serious adverse events (AEs) regardless of causality are located in the Reported AE Module. The number of AEs (including both serious and non-serious) considered related to study drug by the Investigator are presented below. Treatment-emergent AEs are those with an onset after use of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline through Week 12
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Patidegib Gel 2% - Once Daily
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
4
|
5
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Patidegib Gel 2% - Once Daily
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas
Baseline characteristics by cohort
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=12 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 7.81 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 12.32 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 7.85 • n=4 Participants
|
63.9 years
STANDARD_DEVIATION 9.15 • n=21 Participants
|
62.5 years
STANDARD_DEVIATION 9.33 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
12 participants
n=21 Participants
|
36 participants
n=8 Participants
|
|
Weight
|
86.43 kilograms (kg)
STANDARD_DEVIATION 21.248 • n=5 Participants
|
83.93 kilograms (kg)
STANDARD_DEVIATION 14.901 • n=7 Participants
|
99.50 kilograms (kg)
STANDARD_DEVIATION 23.595 • n=5 Participants
|
73.93 kilograms (kg)
STANDARD_DEVIATION 10.874 • n=4 Participants
|
83.76 kilograms (kg)
STANDARD_DEVIATION 23.744 • n=21 Participants
|
85.22 kilograms (kg)
STANDARD_DEVIATION 20.69 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
All serious adverse events (SAEs) and all other non-serious adverse events (AEs) regardless of causality are located in the Reported AE Module. The number of AEs (including both serious and non-serious) considered related to study drug by the Investigator are presented below. Treatment-emergent AEs are those with an onset after use of study drug.
Outcome measures
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=5 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=12 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Vehicle Gel - Cohort 3
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Cohort 4
Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - Cohort 4
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - All Cohorts
Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (Including Both Serious and Non-Serious) Causally Related to Study Drug
|
0 number of events
|
0 number of events
|
0 number of events
|
2 number of events
|
0 number of events
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants who received at least 1 dose of study drug who had evaluable GLI1 mRNA data at Baseline and Week 12.
GLI1 change is a biomarker of the HH signaling pathway. A change in GLI1 mRNA levels reflect a change in the HH pathway. Surgically eligible basal cell carcinomas (SEBs) were defined as clinically diagnosed basal cell carcinoma (BCC) 5 to 20 millimeters (mm) in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. A single baseline BCC designated as a treatment-targeted tumor at Baseline was biopsied first at Baseline and again following 12 weeks of treatment. This was used to assess percent change in GLI1 mRNA levels as follows: (Baseline - Week 12) / Baseline \* 100, with positive numbers to represent increases and negative numbers to represent decreases. Any missing values were not imputed; all available data is summarized.
Outcome measures
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=12 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Vehicle Gel - Cohort 3
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Cohort 4
Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - Cohort 4
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - All Cohorts
Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|---|---|---|---|
|
Molecular Efficacy: Percent Change From Baseline in the Hedgehog (HH) Signaling Pathway Target Gene Glioma-associated Oncogene Homolog 1 (GLI1) Messenger Ribonucleic Acid (mRNA) Levels at Week 12
|
-56.300 percent change in GLI1 mRNA levels
Standard Deviation 99.5901
|
-3.243 percent change in GLI1 mRNA levels
Standard Deviation 69.0247
|
-42.510 percent change in GLI1 mRNA levels
Standard Deviation 55.6352
|
-28.847 percent change in GLI1 mRNA levels
Standard Deviation 46.2318
|
23.306 percent change in GLI1 mRNA levels
Standard Deviation 51.6076
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who received at least 1 dose of study drug.
SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percent change in greatest diameters of treatment-targeted surgically eligible basal cell carcinomas (SEBs) from Baseline to Week 12 was calculated as follows: (sum \[Baseline\] - sum \[Week 12\] / sum \[Baseline\] \* 100), where sum = the greatest diameters of treatment-targeted SEBs and positive numbers to represent increases and negative numbers to represent decreases. Missing values were imputed using Last-Observation Carried Forward (LOCF).
Outcome measures
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=3 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=3 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=6 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Vehicle Gel - Cohort 3
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Cohort 4
n=6 Participants
Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - Cohort 4
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - All Cohorts
Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Efficacy: Percent Change From Baseline in Tumor Size of Treatment-targeted SEBs at Week 12
|
56.15 percent change in tumor size
Standard Deviation 48.138
|
5.08 percent change in tumor size
Standard Deviation 33.541
|
8.73 percent change in tumor size
Standard Deviation 46.600
|
51.11 percent change in tumor size
Standard Deviation 60.584
|
17.01 percent change in tumor size
Standard Deviation 36.870
|
51.11 percent change in tumor size
Standard Deviation 42.861
|
18.41 percent change in tumor size
Standard Deviation 60.592
|
33.33 percent change in tumor size
Standard Deviation 57.735
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who received at least 1 dose of study drug.
SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percentage of tumors showing a complete or partial response at Week 12 was calculated as follows: (Number of baseline treatment-targeted SEBs showing complete or partial response at Week 12) / (Number of Baseline treatment-targeted SEBs) \* 100. Missing values were not imputed.Complete Response is determined when there is no longer any visible evidence of a lesion consistent with BCC at the site, and Partial Response is determined when although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline.
Outcome measures
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=3 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=3 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=6 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Vehicle Gel - Cohort 3
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Cohort 4
n=6 Participants
Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - Cohort 4
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - All Cohorts
Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Efficacy: Percentage of SEBs Showing Complete or Partial Response at Week 12 as Determined by Blinded Photographic Review
|
71.4 percentage of SEBs
|
0 percentage of SEBs
|
50.0 percentage of SEBs
|
100 percentage of SEBs
|
25.0 percentage of SEBs
|
100 percentage of SEBs
|
66.7 percentage of SEBs
|
50.0 percentage of SEBs
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Weeks 2, 6, 8, 10, and 12Population: Participants who received at least 1 dose of study drug.
The ISGTA is a scale with scores ranging from 0 (clear), 1 (almost clear), 2 (minimal residual tumor), to 3 (clearly visible tumor). The Investigator assessed each Baseline treatment-targeted SEB at Weeks 2, 6, 8, 10, and 12. SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percentage of Baseline treatment-targeted SEBs evaluated as being clear or almost clear at Week x (Week x = 2, 6, 8, 10, or 12) based on the ISGTA scale was calculated as follows: (Number of baseline treatment-targeted SEBs with ISGTA score of 0 or 1 at Week x) / (Number of Baseline treatment-targeted SEBs) \* 100. Missing data were imputed using LOCF. The percentage of responders achieving clear (0) or almost clear (1) on the ISGTA scale are presented by Week.
Outcome measures
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=3 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=3 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=6 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Vehicle Gel - Cohort 3
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Cohort 4
n=6 Participants
Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - Cohort 4
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - All Cohorts
Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Treatment-targeted SEBs Achieving Clear or Almost Clear on the Investigator Static Global Tumor Assessment (ISGTA) Scale
Week 2
|
14.3 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
33.3 percentage of SEBs
|
28.6 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
—
|
|
Percentage of Treatment-targeted SEBs Achieving Clear or Almost Clear on the Investigator Static Global Tumor Assessment (ISGTA) Scale
Week 6
|
14.3 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
33.3 percentage of SEBs
|
14.3 percentage of SEBs
|
0 percentage of SEBs
|
16.7 percentage of SEBs
|
0 percentage of SEBs
|
—
|
|
Percentage of Treatment-targeted SEBs Achieving Clear or Almost Clear on the Investigator Static Global Tumor Assessment (ISGTA) Scale
Week 8
|
14.3 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
33.3 percentage of SEBs
|
14.3 percentage of SEBs
|
0 percentage of SEBs
|
16.7 percentage of SEBs
|
0 percentage of SEBs
|
—
|
|
Percentage of Treatment-targeted SEBs Achieving Clear or Almost Clear on the Investigator Static Global Tumor Assessment (ISGTA) Scale
Week 10
|
42.9 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
66.7 percentage of SEBs
|
28.6 percentage of SEBs
|
33.3 percentage of SEBs
|
16.7 percentage of SEBs
|
33.3 percentage of SEBs
|
—
|
|
Percentage of Treatment-targeted SEBs Achieving Clear or Almost Clear on the Investigator Static Global Tumor Assessment (ISGTA) Scale
Week 12
|
57.1 percentage of SEBs
|
0 percentage of SEBs
|
16.7 percentage of SEBs
|
33.3 percentage of SEBs
|
14.3 percentage of SEBs
|
33.3 percentage of SEBs
|
16.7 percentage of SEBs
|
33.3 percentage of SEBs
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Participants who received at least 1 dose of study drug.
SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percent change in greatest diameters of Baseline treatment-targeted SEBs from Baseline to Week 12 was calculated as follows: (sum \[Baseline\] - sum \[Week 12\] / sum \[Baseline\]) \* 100), where sum = the greatest diameters of treatment-targeted SEBs.
Outcome measures
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=3 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=3 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=6 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Vehicle Gel - Cohort 3
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Cohort 4
n=6 Participants
Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - Cohort 4
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - All Cohorts
Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Treatment-targeted SEBs Tumor Size From Baseline as Determined by Blinded Photographic Review
|
-43.464 percentage change from Baseline
Standard Deviation 55.7676
|
24.995 percentage change from Baseline
Standard Deviation 32.3747
|
-3.686 percentage change from Baseline
Standard Deviation 37.8650
|
46.095 percentage change from Baseline
Standard Deviation 97.4129
|
-13.462 percentage change from Baseline
Standard Deviation 60.7358
|
-69.518 percentage change from Baseline
Standard Deviation 52.7961
|
-25.836 percentage change from Baseline
Standard Deviation 45.5819
|
-26.481 percentage change from Baseline
Standard Deviation 59.9186
|
—
|
POST_HOC outcome
Timeframe: Week 12Population: Participants who received at least 1 dose of study drug.
The ISGTA is a scale with scores ranging from 0 (clear), 1 (almost clear), 2 (minimal residual tumor), to 3 (clearly visible tumor). The Investigator assessed each Baseline treatment-targeted SEB at Week 12. SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percentage of Baseline treatment-targeted SEBs evaluated as being clear at Week 12 based on the ISGTA scale and BCC not present was calculated as follows: (Number of baseline treatment-targeted SEBs with ISGTA score of 0 and BCC not present at Week 12) / (Number of Baseline treatment-targeted SEBs) \* 100.
Outcome measures
| Measure |
Patidegib Gel 2% - Once Daily
n=6 Participants
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=3 Participants
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=6 Participants
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=3 Participants
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=6 Participants
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
Vehicle Gel - Cohort 3
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Cohort 4
n=6 Participants
Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - Cohort 4
n=3 Participants
Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel - All Cohorts
n=12 Participants
Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Treatment-targeted SEBs Achieving Clear on the ISGTA Scale and BCC Not Present at Week 12
|
42.9 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
20.0 percentage of SEBs
|
0 percentage of SEBs
|
16.7 percentage of SEBs
|
0 percentage of SEBs
|
0 percentage of SEBs
|
Adverse Events
Patidegib Gel 2% - Once Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Patidegib Gel 4% - Once Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Patidegib Gel 2% - Twice Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Patidegib Gel 4% - Twice Daily
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patidegib Gel 2% - Once Daily
n=6 participants at risk
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=6 participants at risk
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=5 participants at risk
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=6 participants at risk
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=12 participants at risk
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • Number of events 1 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
Other adverse events
| Measure |
Patidegib Gel 2% - Once Daily
n=6 participants at risk
Applied topically once daily for 12 weeks (Cohort 1)
|
Patidegib Gel 4% - Once Daily
n=6 participants at risk
Applied topically once daily for 12 weeks (Cohort 2)
|
Patidegib Gel 2% - Twice Daily
n=5 participants at risk
Applied topically twice daily for 12 weeks (Cohort 3)
|
Patidegib Gel 4% - Twice Daily
n=6 participants at risk
Applied topically twice daily for 12 weeks (Cohort 4)
|
Vehicle Gel
n=12 participants at risk
Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
|
|---|---|---|---|---|---|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Eye disorders
Pterygium
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
20.0%
1/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
General disorders
Application site oedema
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
General disorders
Fatigue
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
20.0%
1/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
20.0%
1/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
20.0%
1/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Neuromuscular pain
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
16.7%
1/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/5 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
0.00%
0/6 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
8.3%
1/12 • 14 weeks
All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place