Plaque Psoriasis
Conditions
Brief summary
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).
Detailed description
The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.
Interventions
DRUGIDP-122 Lotion
Medicated topical lotion
Vehicle topical lotion with no active ingredient
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, of any race, at least 18 years of age (inclusive). * Freely provides both verbal and written informed consent. * Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation. * Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).
Exclusion criteria
* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator. * Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator. * Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator. * Is pregnant, nursing an infant, or planning a pregnancy during the study period. * Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Success at Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Weeks 2, 4, 6, and 12 (4-week follow-up) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-122 Lotion Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks. | 142 |
| IDP-122 Vehicle Lotion Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks. | 71 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | IDP-122 Lotion | IDP-122 Vehicle Lotion | Total |
|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 13.31 | 53.4 years STANDARD_DEVIATION 12.73 | 53.9 years STANDARD_DEVIATION 13.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 23 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 107 Participants | 48 Participants | 155 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Investigator's Global Assessment [IGA] Score 0 - Clear | 0 participants | 0 participants | 0 participants |
| Investigator's Global Assessment [IGA] Score 1 - Almost Clear | 0 participants | 0 participants | 0 participants |
| Investigator's Global Assessment [IGA] Score 2 - Mild | 0 participants | 0 participants | 0 participants |
| Investigator's Global Assessment [IGA] Score 3 - Moderate | 124 participants | 65 participants | 189 participants |
| Investigator's Global Assessment [IGA] Score 4 - Severe | 18 participants | 6 participants | 24 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized Black or African American | 12 participants | 2 participants | 14 participants |
| Race/Ethnicity, Customized Mexican | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Mixed | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Philipino | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Puerto Rican | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized South Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Unknown | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 122 participants | 61 participants | 183 participants |
| Sex: Female, Male Female | 55 Participants | 29 Participants | 84 Participants |
| Sex: Female, Male Male | 87 Participants | 42 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 142 | 0 / 71 |
| other Total, other adverse events | 0 / 142 | 0 / 71 |
| serious Total, serious adverse events | 2 / 142 | 1 / 71 |
Outcome results
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.
Time frame: Week 8
Population: Participants who were randomized and dispensed study drug (ITT population). Markov Chain Monte Carlo (MCMC) multiple imputation was used to impute missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-122 Lotion | Percentage of Participants With Treatment Success at Week 8 | 38.41 percentage of participants |
| IDP-122 Vehicle Lotion | Percentage of Participants With Treatment Success at Week 8 | 11.99 percentage of participants |
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.
Time frame: Weeks 2, 4, 6, and 12 (4-week follow-up)
Population: Participants who were randomized and dispensed study drug (ITT population). MCMC multiple imputation was used to impute missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-122 Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 4 | 19.26 percentage of participants |
| IDP-122 Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 2 | 4.93 percentage of participants |
| IDP-122 Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 6 | 27.71 percentage of participants |
| IDP-122 Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 12 | 23.04 percentage of participants |
| IDP-122 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 12 | 9.34 percentage of participants |
| IDP-122 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 6 | 4.35 percentage of participants |
| IDP-122 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 2 | 0.00 percentage of participants |
| IDP-122 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | Week 4 | 0.20 percentage of participants |