Plaque Psoriasis
Conditions
Brief summary
Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis
Detailed description
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Interventions
DRUGIDP-118 Lotion
Lotion
Lotion
Sponsors
Dow Pharmaceutical Sciences
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
Key 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 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). Key
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 |
|---|---|---|
| The Percentage of Participants With Treatment Success at Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-118 Lotion Lotion
IDP-118 Lotion: Lotion | 141 |
| IDP-118 Vehicle Lotion Vehicle Lotion
IDP-118 Vehicle Lotion: Lotion | 74 |
| Total | 215 |
Baseline characteristics
| Characteristic | IDP-118 Lotion | IDP-118 Vehicle Lotion | Total |
|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 14.84 | 51.8 years STANDARD_DEVIATION 13.18 | 51.8 years STANDARD_DEVIATION 14.26 |
| Sex: Female, Male Female | 55 Participants | 24 Participants | 79 Participants |
| Sex: Female, Male Male | 86 Participants | 50 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 137 | 4 / 73 |
| serious Total, serious adverse events | 0 / 137 | 0 / 73 |
Outcome results
Primary
The Percentage of Participants With Treatment Success at Week 8
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.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-118 Lotion | The Percentage of Participants With Treatment Success at Week 8 | 45.33 percentage of participants |
| IDP-118 Vehicle Lotion | The Percentage of Participants With Treatment Success at Week 8 | 12.51 percentage of participants |
Secondary
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-118 Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 12 | 33.35 percentage of participants |
| IDP-118 Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 6 | 37.53 percentage of participants |
| IDP-118 Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 4 | 26.96 percentage of participants |
| IDP-118 Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 2 | 9.77 percentage of participants |
| IDP-118 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 2 | 0 percentage of participants |
| IDP-118 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 12 | 8.84 percentage of participants |
| IDP-118 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 4 | 1.36 percentage of participants |
| IDP-118 Vehicle Lotion | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Week 6 | 8.24 percentage of participants |