Trial Outcomes & Findings for Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis (NCT NCT02462070)
NCT ID: NCT02462070
Last Updated: 2020-08-20
Results Overview
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
203 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-08-20
Participant Flow
Participant milestones
| Measure |
IDP-118 Lotion
Lotion
IDP-118 Lotion: Lotion
|
IDP-118 Vehicle Lotion
Vehicle Lotion
IDP-118 Vehicle Lotion: Lotion
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
68
|
|
Overall Study
COMPLETED
|
112
|
57
|
|
Overall Study
NOT COMPLETED
|
23
|
11
|
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=135 Participants
Lotion
IDP-118 Lotion: Lotion
|
IDP-118 Vehicle Lotion
n=68 Participants
Vehicle Lotion
IDP-118 Vehicle Lotion: Lotion
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 13.25 • n=39 Participants
|
50.0 years
STANDARD_DEVIATION 13.25 • n=41 Participants
|
48.8 years
STANDARD_DEVIATION 13.25 • n=35 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
67 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
136 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 8 weeksTreatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
IDP-118 Lotion
n=135 Participants
Lotion
IDP-118 Lotion: Lotion
|
IDP-118 Vehicle Lotion
n=68 Participants
Vehicle Lotion
IDP-118 Vehicle Lotion: Lotion
|
|---|---|---|
|
The Percentage of Participants With Treatment Success at Week 8
|
35.76 percentage of participants
|
6.98 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksTreatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
IDP-118 Lotion
n=135 Participants
Lotion
IDP-118 Lotion: Lotion
|
IDP-118 Vehicle Lotion
n=68 Participants
Vehicle Lotion
IDP-118 Vehicle Lotion: Lotion
|
|---|---|---|
|
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
Week 12
|
33.25 percentage of participants
|
8.51 percentage of participants
|
|
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
Week 6
|
37.84 percentage of participants
|
6.67 percentage of participants
|
|
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
Week 4
|
24.86 percentage of participants
|
9.33 percentage of participants
|
|
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
Week 2
|
9.15 percentage of participants
|
2.98 percentage of participants
|
Adverse Events
IDP-118 Lotion
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
IDP-118 Vehicle Lotion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDP-118 Lotion
n=133 participants at risk
Lotion
IDP-118 Lotion: Lotion
|
IDP-118 Vehicle Lotion
n=67 participants at risk
Vehicle Lotion
IDP-118 Vehicle Lotion: Lotion
|
|---|---|---|
|
Infections and infestations
Cellulitis staphylococcal
|
0.75%
1/133 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
0.00%
0/67 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
0.75%
1/133 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
0.00%
0/67 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.75%
1/133 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
0.00%
0/67 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.75%
1/133 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
0.00%
0/67 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
IDP-118 Lotion
n=133 participants at risk
Lotion
IDP-118 Lotion: Lotion
|
IDP-118 Vehicle Lotion
n=67 participants at risk
Vehicle Lotion
IDP-118 Vehicle Lotion: Lotion
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
7/133 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
0.00%
0/67 • 12 weeks
Safety analysis set included all participants who were randomized, received at least one confirmed dose of study drug, and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contract sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER