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This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).
This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-122 Lotion | Experimental | Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks. |
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| IDP-122 Vehicle Lotion | Active Comparator | Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-122 Lotion | Drug | Topical lotion |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Success at Week 8 | 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. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binu j Alexander | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 11 | Hot Springs | Arkansas | 71901 | United States | ||
| Valeant Site 1 |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-122 Lotion | Participants applied IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks. |
| FG001 | IDP-122 Vehicle Lotion | Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2015 |
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| IDP-122 Vehicle Lotion | Drug | Topical lotion. No active ingredient. |
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| Weeks 2, 4, 6, and 12 (4-week follow-up) |
| Encinitas |
| California |
| 92023 |
| United States |
| Valeant Site 10 | Encino | California | 91436 | United States |
| Valeant Site 12 | Santa Rosa | California | 95401 | United States |
| Valeant Site 13 | Atlanta | Georgia | 30301 | United States |
| Valeant Site 7 | Boise | Idaho | 83701 | United States |
| Valeant Site 6 | Rockville | Maryland | 20847 | United States |
| Valeant Site 4 | Ann Arbor | Michigan | 48103 | United States |
| Valeant Site 8 | Clarkston | Michigan | 48346 | United States |
| Valeant Site 15 | Las Vegas | Nevada | 89101 | United States |
| Valeant Site 9 | Raleigh | North Carolina | 27601 | United States |
| Valeant Site 5 | Knoxville | Tennessee | 37901 | United States |
| Valeant Site 3 | Austin | Texas | 73301 | United States |
| Valeant Site 2 | San Antonio | Texas | 78201 | United States |
| Valeant Site 14 | Spokane | Washington | 99201 | United States |
| Intent-to-Treat (ITT) Population | Participants who were randomized and dispensed study drug. |
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| Safety Population | Randomized participants with ≥1 confirmed dose of study drug and ≥1 post-Baseline safety assessment. |
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| COMPLETED |
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| NOT COMPLETED |
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Participants who were randomized and dispensed study drug (ITT population).
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-122 Lotion | Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks. |
| BG001 | IDP-122 Vehicle Lotion | Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Investigator's Global Assessment [IGA] Score | 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). | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment Success at Week 8 | 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. | Participants who were randomized and dispensed study drug (ITT population). Markov Chain Monte Carlo (MCMC) multiple imputation was used to impute missing data. | Posted | Number | percentage of participants | Week 8 |
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| Secondary | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | 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. | Participants who were randomized and dispensed study drug (ITT population). MCMC multiple imputation was used to impute missing data. | Posted | Number | percentage of participants | Weeks 2, 4, 6, and 12 (4-week follow-up) |
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Baseline through Week 12
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDP-122 Lotion | Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks. | 0 | 142 | 1 | 142 | 0 | 142 |
| EG001 | IDP-122 Vehicle Lotion | Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks. | 0 | 72 | 3 | 72 | 0 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lobar pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Application site cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc. | 1-510-259-5284 | aloncaric@bauschhealth.com |
| Jan 14, 2020 |
| Prot_SAP_000.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Turkish |
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| Unknown |
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| 1 - Almost Clear |
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| 2 - Mild |
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| 3 - Moderate |
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| 4 - Severe |
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