Trial Outcomes & Findings for Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis (NCT NCT02515097)
NCT ID: NCT02515097
Last Updated: 2020-01-27
Results Overview
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
213 participants
Primary outcome timeframe
Week 8
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
IDP-122 Lotion
Participants applied IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks.
|
IDP-122 Vehicle Lotion
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
71
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
142
|
71
|
|
Overall Study
Safety Population
|
142
|
70
|
|
Overall Study
COMPLETED
|
135
|
65
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
IDP-122 Lotion
Participants applied IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks.
|
IDP-122 Vehicle Lotion
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
IDP-122 Lotion
n=142 Participants
Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
|
IDP-122 Vehicle Lotion
n=71 Participants
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 12.73 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 13.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 participants
n=5 Participants
|
2 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
122 participants
n=5 Participants
|
61 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Puerto Rican
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Philipino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Investigator's Global Assessment [IGA] Score
0 - Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Investigator's Global Assessment [IGA] Score
1 - Almost Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Investigator's Global Assessment [IGA] Score
2 - Mild
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Investigator's Global Assessment [IGA] Score
3 - Moderate
|
124 participants
n=5 Participants
|
65 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Investigator's Global Assessment [IGA] Score
4 - Severe
|
18 participants
n=5 Participants
|
6 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Participants who were randomized and dispensed study drug (ITT population). Markov Chain Monte Carlo (MCMC) multiple imputation was used to impute missing data.
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Outcome measures
| Measure |
IDP-122 Lotion
n=142 Participants
Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
|
IDP-122 Vehicle Lotion
n=71 Participants
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Treatment Success at Week 8
|
38.41 percentage of participants
|
11.99 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, and 12 (4-week follow-up)Population: Participants who were randomized and dispensed study drug (ITT population). MCMC multiple imputation was used to impute missing data.
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Outcome measures
| Measure |
IDP-122 Lotion
n=142 Participants
Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
|
IDP-122 Vehicle Lotion
n=71 Participants
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Week 2
|
4.93 percentage of participants
|
0.00 percentage of participants
|
|
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Week 4
|
19.26 percentage of participants
|
0.20 percentage of participants
|
|
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Week 6
|
27.71 percentage of participants
|
4.35 percentage of participants
|
|
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Week 12
|
23.04 percentage of participants
|
9.34 percentage of participants
|
Adverse Events
IDP-122 Lotion
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
IDP-122 Vehicle Lotion
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDP-122 Lotion
n=142 participants at risk
Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
|
IDP-122 Vehicle Lotion
n=71 participants at risk
Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.70%
1/142 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
0.00%
0/71 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
|
Infections and infestations
Staphylococcal infection
|
0.70%
1/142 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
0.00%
0/71 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
|
Infections and infestations
Sepsis
|
0.70%
1/142 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
0.00%
0/71 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/142 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
1.4%
1/71 • Baseline through Week 12
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
|
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Operations
Bausch Health Americas, Inc.
Phone: 1-510-259-5284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER