Trial Outcomes & Findings for Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT02785185)

NCT ID: NCT02785185

Last Updated: 2020-08-27

Results Overview

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 Week 2. 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: 150 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2020-08-27

Participant Flow

Participant milestones

Measure	IDP-122 Lotion Lotion IDP-122 Lotion: Lotion	Ultravate Cream Cream Ultravate Cream: Cream	IDP-122 Vehicle Lotion Lotion IDP-122 Vehicle Lotion: Vehicle	IDP-122 Vehicle Cream Cream IDP-122 Vehicle Cream: Vehicle
Overall Study STARTED	60	57	17	16
Overall Study COMPLETED	59	56	15	16
Overall Study NOT COMPLETED	1	1	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Measure	IDP-122 Lotion n=60 Participants Lotion IDP-122 Lotion: Lotion	Ultravate Cream n=57 Participants Cream Ultravate Cream: Cream	IDP-122 Vehicle Lotion n=17 Participants Lotion IDP-122 Vehicle Lotion: Vehicle	IDP-122 Vehicle Cream n=16 Participants Cream IDP-122 Vehicle Cream: Vehicle	Total n=150 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 14.2 • n=5 Participants	50.2 years STANDARD_DEVIATION 10.91 • n=7 Participants	44.7 years STANDARD_DEVIATION 8.8 • n=5 Participants	48.6 years STANDARD_DEVIATION 14.98 • n=4 Participants	49.6 years STANDARD_DEVIATION 12.6 • n=21 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	6 Participants n=5 Participants	12 Participants n=4 Participants	70 Participants n=21 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	30 Participants n=7 Participants	11 Participants n=5 Participants	4 Participants n=4 Participants	80 Participants n=21 Participants

PRIMARY outcome

Timeframe: 2 weeks

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 Week 2. 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-122 Lotion n=60 Participants Lotion IDP-122 Lotion: Lotion	Ultravate Cream n=57 Participants Cream Ultravate Cream: Cream	IDP-122 Vehicle Lotion n=17 Participants Lotion IDP-122 Vehicle Lotion: Vehicle	IDP-122 Vehicle Cream n=16 Participants Cream IDP-122 Vehicle Cream: 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 2	18 Participants	18 Participants	3 Participants	1 Participants

Adverse Events

IDP-122 Lotion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultravate Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IDP-122 Vehicle Lotion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

IDP-122 Vehicle Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IDP-122 Lotion n=60 participants at risk Lotion IDP-122 Lotion: Lotion	Ultravate Cream n=57 participants at risk Cream Ultravate Cream: Cream	IDP-122 Vehicle Lotion n=15 participants at risk Lotion IDP-122 Vehicle Lotion: Vehicle	IDP-122 Vehicle Cream n=16 participants at risk Cream IDP-122 Vehicle Cream: Vehicle
General disorders Application site warmth	0.00% 0/60 • 8 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% 0/57 • 8 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).	6.7% 1/15 • 8 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% 0/16 • 8 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

Study Director

Bausch Health

Email: anya.loncaric@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Contact sponsor directly for details.
• Publication restrictions are in place

Restriction type: OTHER