Trial Outcomes & Findings for Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis (NCT NCT02045277)
NCT ID: NCT02045277
Last Updated: 2020-08-20
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
212 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-08-20
Participant Flow
Participant milestones
| Measure |
IDP-118 Lotion
halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion: Lotion
|
IDP-118 Monad HP Lotion
HP
IDP-118 Monad HP Lotion: Active Comparator
|
IDP-118 Monad Taz Lotion
Taz
IDP-118 Monad Taz Lotion: Active Comparator
|
IDP-118 Vehicle Lotion
Vehicle
IDP-118 Vehicle Lotion: Vehicle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
63
|
59
|
31
|
|
Overall Study
COMPLETED
|
55
|
62
|
47
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
12
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
IDP-118 Lotion
n=59 Participants
halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion: Lotion
|
IDP-118 Monad HP Lotion
n=63 Participants
HP
IDP-118 Monad HP Lotion: Active Comparator
|
IDP-118 Monad Taz Lotion
n=59 Participants
Taz
IDP-118 Monad Taz Lotion: Active Comparator
|
IDP-118 Vehicle Lotion
n=31 Participants
Vehicle
IDP-118 Vehicle Lotion: Vehicle
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 13.70 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 11.52 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 13.10 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 16.11 • n=4 Participants
|
52.66 years
STANDARD_DEVIATION 13.55 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksTreatment 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).
Outcome measures
| Measure |
IDP-118 Lotion
n=59 Participants
halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion: Lotion
|
IDP-118 Monad HP Lotion
n=63 Participants
HP
IDP-118 Monad HP Lotion: Active Comparator
|
IDP-118 Monad Taz Lotion
n=59 Participants
Taz
IDP-118 Monad Taz Lotion: Active Comparator
|
IDP-118 Vehicle Lotion
n=31 Participants
Vehicle
IDP-118 Vehicle Lotion: Vehicle
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8
|
52.5 percentage of participants
|
33.3 percentage of participants
|
18.6 percentage of participants
|
9.7 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2, 4, 6, and 12 (4-week follow-up)Population: The number of participants with IGA results at each visit were utilized in the analysis.
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).
Outcome measures
| Measure |
IDP-118 Lotion
n=59 Participants
halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion: Lotion
|
IDP-118 Monad HP Lotion
n=63 Participants
HP
IDP-118 Monad HP Lotion: Active Comparator
|
IDP-118 Monad Taz Lotion
n=59 Participants
Taz
IDP-118 Monad Taz Lotion: Active Comparator
|
IDP-118 Vehicle Lotion
n=31 Participants
Vehicle
IDP-118 Vehicle Lotion: Vehicle
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
Week 2
|
11.9 percentage of participants
|
4.8 percentage of participants
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
Week 6
|
32.2 percentage of participants
|
25.4 percentage of participants
|
15.3 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
Week 4
|
25.4 percentage of participants
|
17.5 percentage of participants
|
1.7 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
Week 12
|
38.2 percentage of participants
|
21.0 percentage of participants
|
12.8 percentage of participants
|
6.9 percentage of participants
|
Adverse Events
IDP-118 Lotion
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
IDP-118 Monad HP Lotion
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
IDP-118 Monad Taz Lotion
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
IDP-118 Vehicle Lotion
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDP-118 Lotion
n=59 participants at risk
halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion: Lotion
|
IDP-118 Monad HP Lotion
n=62 participants at risk
HP
IDP-118 Monad HP Lotion: Active Comparator
|
IDP-118 Monad Taz Lotion
n=58 participants at risk
Taz
IDP-118 Monad Taz Lotion: Active Comparator
|
IDP-118 Vehicle Lotion
n=31 participants at risk
Vehicle
IDP-118 Vehicle Lotion: Vehicle
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/59 • 12 weeks
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).
|
1.6%
1/62 • 12 weeks
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%
0/58 • 12 weeks
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%
0/31 • 12 weeks
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).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/59 • 12 weeks
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).
|
1.6%
1/62 • 12 weeks
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%
0/58 • 12 weeks
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%
0/31 • 12 weeks
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).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/59 • 12 weeks
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%
0/62 • 12 weeks
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%
0/58 • 12 weeks
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).
|
3.2%
1/31 • 12 weeks
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).
|
|
General disorders
Hernia obstructive
|
0.00%
0/59 • 12 weeks
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%
0/62 • 12 weeks
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%
0/58 • 12 weeks
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).
|
3.2%
1/31 • 12 weeks
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
Infection
|
0.00%
0/59 • 12 weeks
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%
0/62 • 12 weeks
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%
0/58 • 12 weeks
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).
|
3.2%
1/31 • 12 weeks
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/59 • 12 weeks
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%
0/62 • 12 weeks
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).
|
1.7%
1/58 • 12 weeks
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%
0/31 • 12 weeks
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
| Measure |
IDP-118 Lotion
n=59 participants at risk
halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion: Lotion
|
IDP-118 Monad HP Lotion
n=62 participants at risk
HP
IDP-118 Monad HP Lotion: Active Comparator
|
IDP-118 Monad Taz Lotion
n=58 participants at risk
Taz
IDP-118 Monad Taz Lotion: Active Comparator
|
IDP-118 Vehicle Lotion
n=31 participants at risk
Vehicle
IDP-118 Vehicle Lotion: Vehicle
|
|---|---|---|---|---|
|
General disorders
Application site erythema
|
1.7%
1/59 • 12 weeks
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%
0/62 • 12 weeks
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).
|
5.2%
3/58 • 12 weeks
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%
0/31 • 12 weeks
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).
|
|
General disorders
Application site pain
|
3.4%
2/59 • 12 weeks
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%
0/62 • 12 weeks
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).
|
8.6%
5/58 • 12 weeks
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).
|
3.2%
1/31 • 12 weeks
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).
|
|
General disorders
Application site pruritus
|
3.4%
2/59 • 12 weeks
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%
0/62 • 12 weeks
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).
|
6.9%
4/58 • 12 weeks
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%
0/31 • 12 weeks
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).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/59 • 12 weeks
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%
0/62 • 12 weeks
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%
0/58 • 12 weeks
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).
|
6.5%
2/31 • 12 weeks
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).
|
|
Nervous system disorders
Headache
|
5.1%
3/59 • 12 weeks
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%
0/62 • 12 weeks
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).
|
1.7%
1/58 • 12 weeks
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).
|
3.2%
1/31 • 12 weeks
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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER