Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT02514577
• Recruitment Status: Completed
• First Posted: August 3, 2015
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Plaque Psoriasis
• Interventions: Drug: IDP-122 Lotion; Drug: IDP-122 Vehicle Lotion
• Enrollment: 217

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	IDP-122 Lotion	IDP-122 Vehicle Lotion
Arm/Group Description	Participants applied IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.	Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Period Title: Overall Study
Started	143	74
Intent-to-Treat (ITT) Population [1]	143	74
Safety Population [2]	142	72
Completed	129	61
Not Completed	14	13
Reason Not Completed
Lost to Follow-up	6	6
Protocol Violation	1	0
Withdrawal by Subject	6	6
Adverse Event	1	1
[1] Participants who were randomized and dispensed study drug.; [2] Randomized participants with ≥1 confirmed dose of study drug and ≥1 post-Baseline safety assessment.

Baseline Characteristics

Arm/Group Title		IDP-122 Lotion	IDP-122 Vehicle Lotion	Total
Arm/Group Description		Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.	Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		143	74	217
Baseline Analysis Population Description		Participants who were randomized and dispensed study drug (ITT population).
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	143 participants	74 participants	217 participants
		51.6 (14.84)	51.0 (15.43)	51.4 (15.01)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	143 participants	74 participants	217 participants
	Female	58 40.6%	35 47.3%	93 42.9%
	Male	85 59.4%	39 52.7%	124 57.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	143 participants	74 participants	217 participants
	Hispanic or Latino	41 28.7%	20 27.0%	61 28.1%
	Not Hispanic or Latino	102 71.3%	54 73.0%	156 71.9%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	143 participants	74 participants	217 participants
Asian		5	2	7
Black or African American		13	3	16
Native Hawaiian or Other Pacific Islander		2	1	3
White		121	68	189
Turkish		1	0	1
Unknown		1	0	1
Investigator's Global Assessment [IGA] Score [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	143 participants	74 participants	217 participants
0 - Clear		0	0	0
1 - Almost Clear		0	0	0
2 - Mild		0	0	0
3 - Moderate		121	61	182
4 - Severe		22	13	35
		[1] Measure Description: 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

1. Primary Outcome

Title	Percentage of Participants With Treatment Success at Week 8
Description	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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Participants who were randomized and dispensed study drug (ITT population). Markov Chain Monte Carlo (MCMC) multiple imputation was used to impute missing data.

Arm/Group Title	IDP-122 Lotion	IDP-122 Vehicle Lotion
Arm/Group Description:	Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.	Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Overall Number of Participants Analyzed	143	74
Measure Type: Number; Unit of Measure: percentage of participants
	36.5	8.13

2. Secondary Outcome

Title	Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Description	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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time Frame	Weeks 2, 4, 6, and 12 (4-week follow-up)

Outcome Measure Data

Analysis Population Description

Participants who were randomized and dispensed study drug (ITT population). MCMC multiple imputation was used to impute missing data.

Arm/Group Title	IDP-122 Lotion	IDP-122 Vehicle Lotion
Arm/Group Description:	Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.	Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Overall Number of Participants Analyzed	143	74
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	7.06	0
Week 4	19.81	2.77
Week 6	30.14	7.93
Week 12	19.48	6.69

Adverse Events

Time Frame	Baseline through Week 12
Adverse Event Reporting Description	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).
Arm/Group Title	IDP-122 Lotion	IDP-122 Vehicle Lotion
Arm/Group Description	Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.	Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
All-Cause Mortality
	IDP-122 Lotion	IDP-122 Vehicle Lotion
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/142 (0.00%)	0/72 (0.00%)
Serious Adverse Events
	IDP-122 Lotion	IDP-122 Vehicle Lotion
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/142 (0.70%)	3/72 (4.17%)
Cardiac disorders
Cardiac failure chronic † 1	1/142 (0.70%)	1/72 (1.39%)
Gastrointestinal disorders
Anal fissure † 1	0/142 (0.00%)	1/72 (1.39%)
Infections and infestations
Lobar pneumonia † 1	0/142 (0.00%)	1/72 (1.39%)
Application site cellulitis † 1	0/142 (0.00%)	1/72 (1.39%)
Diverticulitis † 1	0/142 (0.00%)	1/72 (1.39%)
1 Term from vocabulary, MedDRA 18.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	IDP-122 Lotion	IDP-122 Vehicle Lotion
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/142 (0.00%)	0/72 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Please contact Sponsor directly for additional information.

Results Point of Contact

• Name/Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc.
• Phone: 1-510-259-5284
• EMail: aloncaric@bauschhealth.com

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02514577
• Other Study ID Numbers: V01-122A-301
• First Submitted: July 31, 2015
• First Posted: August 3, 2015
• Results First Submitted: January 14, 2020
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020