Psoriasis
Conditions
Keywords
Tapinarof, Plaque Psoriasis, Scalp Psoriasis, Psoriasis, Phase 4, Topical, Open-label, Efficacy, Safety, Adult, Face Psoriasis, Neck Psoriasis, Psoriatic conditions
Brief summary
This is an open-label, multi-center study to evaluate the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with plaque psoriasis occurring in the head and neck region
Detailed description
This is an open-label study in which participants with plaque psoriasis in the head and neck region will be assigned to receive VTAMA (tapinarof) cream, 1% once daily for 12 weeks. Study participants will have a follow-up period of 1 week. The study duration will be up to 17 weeks.
Interventions
DRUGVTAMA (tapinarof) cream, 1%
VTAMA (tapinarof) cream, 1% applied topically once daily
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older, at the time of signing the informed consent * Participants with clinical diagnosis of plaque psoriasis, including lesion(s) in the head and neck region and stable disease in the head and neck region for at least 3 months prior to the study * Participant has a plaque psoriasis lesion in the head and neck region that is suitable for evaluation as the target lesion and has a PGA (target lesion) score of 2 (Mild), 3 (Moderate), or 4 (Severe) at Screening and Baseline * Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study * Negative pregnancy test at Baseline (Day 1) * Capable of giving written informed consent
Exclusion criteria
* Diagnosis of a type of psoriasis other than plaque psoriasis * Any sign of infection of any of the psoriatic lesions * Concurrent significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study * History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with participation in the study and ability to understand and give informed consent * History of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study * Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001); previous or current use of VTAMA® (Tapinarof) cream, 1% * Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) * UV light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve a Target Lesion Physician Global Assessment (PGA) Score in the Head and Neck Region of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | from Baseline to Week 12 | Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve a Target Lesion PGA Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | Baseline to Week 12 | Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VTAMA (Tapinarof) Cream, 1% VTAMA (tapinarof) cream, 1% applied topically once daily
VTAMA (tapinarof) cream, 1%: VTAMA (tapinarof) cream, 1% applied topically once daily | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | VTAMA (Tapinarof) Cream, 1% |
|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 16.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| PGA (Target Lesion) 0 - Clear | 0 Participants |
| PGA (Target Lesion) 1 - Almost Clear | 0 Participants |
| PGA (Target Lesion) 2 - Mild | 12 Participants |
| PGA (Target Lesion) 3 - Moderate | 17 Participants |
| PGA (Target Lesion) 4 - Severe | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 18 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
Primary
Percentage of Participants Who Achieve a Target Lesion Physician Global Assessment (PGA) Score in the Head and Neck Region of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement
Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.
Time frame: from Baseline to Week 12
Population: Observed cases
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VTAMA (Tapinarof) Cream, 1% | Percentage of Participants Who Achieve a Target Lesion Physician Global Assessment (PGA) Score in the Head and Neck Region of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | 23 Participants |
Secondary
Time to Achieve a Target Lesion PGA Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement
Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.
Time frame: Baseline to Week 12
Population: Observed cases
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VTAMA (Tapinarof) Cream, 1% | Time to Achieve a Target Lesion PGA Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement | 29.0 days |