Trial Outcomes & Findings for Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis (NCT NCT02785172)

NCT ID: NCT02785172

Last Updated: 2020-08-20

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". 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: 154 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2020-08-20

Participant Flow

Participant milestones

Measure	IDP-118 Lotion Lotion IDP-118 Lotion: Lotion	Ultravate Cream Cream Ultravate Cream: Cream	IDP-118 Vehicle Lotion Lotion IDP-118 Vehicle Lotion: Vehicle	IDP-118 Vehicle Cream Cream IDP-118 Vehicle Cream: Vehicle
Overall Study STARTED	61	63	16	14
Overall Study COMPLETED	61	62	15	14
Overall Study NOT COMPLETED	0	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis

Baseline characteristics by cohort

Measure	IDP-118 Lotion n=61 Participants Lotion IDP-118 Lotion: Lotion	Ultravate Cream n=63 Participants Cream Ultravate Cream: Cream	IDP-118 Vehicle Lotion n=16 Participants Lotion IDP-118 Vehicle Lotion: Vehicle	IDP-118 Vehicle Cream n=14 Participants Cream IDP-118 Vehicle Cream: Vehicle	Total n=154 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 13.81 • n=5 Participants	49.5 years STANDARD_DEVIATION 13.47 • n=7 Participants	48.3 years STANDARD_DEVIATION 11.63 • n=5 Participants	52.5 years STANDARD_DEVIATION 9.37 • n=4 Participants	50.36 years STANDARD_DEVIATION 13.06 • n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	21 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	62 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	42 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	92 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". 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=61 Participants Lotion IDP-118 Lotion: Lotion	Ultravate Cream n=63 Participants Cream Ultravate Cream: Cream	IDP-118 Vehicle Lotion n=16 Participants Lotion IDP-118 Vehicle Lotion: Vehicle	IDP-118 Vehicle Cream n=14 Participants Cream IDP-118 Vehicle Cream: Vehicle
Percent of Subjects With Treatment Success	32.79 percentage of participants	33.97 percentage of participants	0 percentage of participants	7.14 percentage of participants

Adverse Events

IDP-118 Lotion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ultravate Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IDP-118 Vehicle Lotion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IDP-118 Vehicle Cream

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IDP-118 Lotion n=61 participants at risk Lotion IDP-118 Lotion: Lotion	Ultravate Cream n=62 participants at risk Cream Ultravate Cream: Cream	IDP-118 Vehicle Lotion n=15 participants at risk Lotion IDP-118 Vehicle Lotion: Vehicle	IDP-118 Vehicle Cream n=14 participants at risk Cream IDP-118 Vehicle Cream: Vehicle
General disorders Application site atrophy	1.6% 1/61 • 2 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 • 2 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% 0/15 • 2 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).	7.1% 1/14 • 2 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.h
• Publication restrictions are in place

Restriction type: OTHER