Chronic Plaque Psoriasis
Conditions
Brief summary
This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis
Detailed description
This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis
Interventions
DRUGTopical roflumilast
Active treatment
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws * Males and females ages 2 years and older (inclusive) * Subjects with chronic plaque psoriasis who meet eligibility criteria and: 1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or 2. Are naïve to treatment with ARQ-151 cream (Cohort 2) * Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
Exclusion criteria
* Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study. * Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. * Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. * Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. * Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product. * Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) | Up to 24 weeks | The percentage of participants with ≥TEAE is reported. |
| Percentage of Participants With ≥1 Serious Adverse Events (SAEs) | Up to 24 weeks | The percentage of participants with ≥1 SAE is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Over Time | Weeks 4, 12, and 24 | The percentage of participants achieving an IGA score of 0 or 1 is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. |
| Duration of Response (DOR) for Participants Achieving an IGA Score of 'Clear' or 'Almost Clear' | Up to Week 30 | The Kaplan-Meier (KM) median DOR (days) of IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The duration of response starts with the first assessment of clear or almost clear, which could be as early as the Week 2 assessment in the feeder study, and continues until the participant's disease worsens or completes their involvement in the study. Therefore, the time variable could be as long as 30 weeks, 6 weeks in the feeder study plus 24 weeks in the ARQ-151-306 study. |
| Return to IGA Score of ≥2 After Achieving an IGA Score of 'Clear' or 'Almost Clear' | Up to Week 24 | The percentage of participants worsening to IGA Score of ≥2 after achieving an IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. |
| Achievement of a 50% Reduction in Psoriasis Area Severity Index (PASI-50) Score Over Time | Weeks 4, 12, and 24 | The percentage of participants achieving PASI-50 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. |
| Achievement of a 75% Reduction in Psoriasis Area Severity Index (PASI-75) Score Over Time | Weeks 4, 12, and 24 | The percentage of participants achieving PASI-75 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. |
| Achievement of a 90% Reduction in Psoriasis Area Severity Index (PASI-90) Score Over Time | Weeks 4, 12, and 24 | The percentage of participants achieving PASI-90 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. |
| Achievement of a 100% Reduction in Psoriasis Area Severity Index (PASI-100) Score Over Time | Weeks 4, 12, and 24 | The percentage of participants achieving PASI-100 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. |
| Achievement of Success in Worst Itch Numeric Rating Scale (WI-NRS) Score Over Time | Weeks 4, 12, and 24 | The percentage of participants achieving WI-NRS success is reported. WI-NRS "success" is defined as a ≥4 point improvement from a baseline score of ≥4. The WI-NRS is a simple, single item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the past 24 hours. Higher scores indicate greater symptom severity. |
Countries
Canada, Dominican Republic, United States
Contacts
STUDY_DIRECTORDavid Berk, MD
Arcutis Biotherapeutics, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 9.8 years STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 104 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 229 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American-Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants |
| Race/Ethnicity, Customized Black or African-American | 0 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants |
| Race/Ethnicity, Customized Other | 11 Participants |
| Race/Ethnicity, Customized White | 246 Participants |
| Sex: Female, Male Female | 135 Participants |
| Sex: Female, Male Male | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 264 | 0 / 9 | 0 / 60 |
| other Total, other adverse events | 10 / 264 | 3 / 9 | 26 / 60 |
| serious Total, serious adverse events | 3 / 264 | 0 / 9 | 1 / 60 |
Outcome results
None listed