Trial Outcomes & Findings for Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis (NCT NCT02462122)

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

215 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-08-20

Participant Flow

Participant milestones

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	141	74
Overall Study COMPLETED	120	61
Overall Study NOT COMPLETED	21	13

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

Baseline characteristics by cohort
Measure	IDP-118 Lotion n=141 Participants Lotion IDP-118 Lotion: Lotion	IDP-118 Vehicle Lotion n=74 Participants Vehicle Lotion IDP-118 Vehicle Lotion: Lotion	Total n=215 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 14.84 • n=39 Participants	51.8 years STANDARD_DEVIATION 13.18 • n=41 Participants	51.8 years STANDARD_DEVIATION 14.26 • n=35 Participants
Sex: Female, Male Female	55 Participants n=39 Participants	24 Participants n=41 Participants	79 Participants n=35 Participants
Sex: Female, Male Male	86 Participants n=39 Participants	50 Participants n=41 Participants	136 Participants n=35 Participants

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	IDP-118 Lotion n=141 Participants Lotion IDP-118 Lotion: Lotion	IDP-118 Vehicle Lotion n=74 Participants Vehicle Lotion IDP-118 Vehicle Lotion: Lotion
The Percentage of Participants With Treatment Success at Week 8	45.33 percentage of participants	12.51 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	IDP-118 Lotion n=141 Participants Lotion IDP-118 Lotion: Lotion	IDP-118 Vehicle Lotion n=74 Participants Vehicle Lotion IDP-118 Vehicle Lotion: Lotion
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 Week 12	33.35 percentage of participants	8.84 percentage of participants
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 Week 6	37.53 percentage of participants	8.24 percentage of participants
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 Week 4	26.96 percentage of participants	1.36 percentage of participants
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 Week 2	9.77 percentage of participants	0 percentage of participants

Adverse Events

IDP-118 Lotion

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

IDP-118 Vehicle Lotion

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IDP-118 Lotion n=137 participants at risk Lotion IDP-118 Lotion: Lotion	IDP-118 Vehicle Lotion n=73 participants at risk Vehicle Lotion IDP-118 Vehicle Lotion: Lotion
Skin and subcutaneous tissue disorders Dermatitis contact	9.5% 13/137 • 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% 0/73 • 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.
Skin and subcutaneous tissue disorders Pruritis	2.9% 4/137 • 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.	5.5% 4/73 • 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

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER