Plaque Psoriasis
Conditions
Brief summary
This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
Detailed description
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis
Interventions
experimental
DRUGVehicle foam
experimental
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws. * Males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents). * Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Mild ('2') at Baseline. * A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline. * A PASI score of at least 2 (excluding the palms and soles) at Baseline. * Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable disease for the past 4 weeks. * Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). * Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. * Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis. * Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
Exclusion criteria
* Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments. * Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. * Subjects currently taking lithium or antimalarial drugs. * Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors). * Current diagnosis of non-plaque forms of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis. * Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements. * Known allergies to excipients in ARQ-154. * Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study. * Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study. * Subjects with PHQ-8 \>/= 10 or modified PHQ-A \>/= 10 at Screening or Baseline. * 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 the investigational product. * Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study. * 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. * Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. * Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal, or antiviral agents within 7 days of Baseline/Day 0. * Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale | Week 8 | The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | Baseline and Weeks 2, 4, 8 | The number of participants with a baseline SI-NRS score ≥4 who achieve success (a ≥4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only. |
| Change From Baseline in Psoriasis Symptoms Diary (PSD) Score | Baseline and Weeks 4 and 8 | The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 (no symptoms) to 10 (worst imaginable symptoms). Scores range from 0 to 160, with higher scores indicating greater symptom severity. |
| Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8 | Week 8 | The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. |
| Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75) | Week 8 | The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. |
| Number of Participants Achieving PSSI-90 | Baseline and Week 8 | The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. |
| Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score | Up to 8 weeks | The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. Results are based on observed data only. |
Countries
Australia, Bulgaria, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Roflumilast Foam 0.3% Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. | 200 |
| Vehicle Foam Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. | 104 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Lost to Follow-up | 8 | 7 |
| Overall Study | Not reported | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 6 |
Baseline characteristics
| Characteristic | Total | Vehicle Foam | Roflumilast Foam 0.3% |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 14.74 | 45.0 years STANDARD_DEVIATION 15.76 | 45.2 years STANDARD_DEVIATION 14.22 |
| Body Investigator Global Assessment (B-IGA) Baseline Score 0 - clear | 0 Participants | 0 Participants | 0 Participants |
| Body Investigator Global Assessment (B-IGA) Baseline Score 1 - almost clear | 0 Participants | 0 Participants | 0 Participants |
| Body Investigator Global Assessment (B-IGA) Baseline Score 2 - mild | 108 Participants | 39 Participants | 69 Participants |
| Body Investigator Global Assessment (B-IGA) Baseline Score 3 - moderate | 179 Participants | 60 Participants | 119 Participants |
| Body Investigator Global Assessment (B-IGA) Baseline Score 4 - severe | 15 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 63 Participants | 25 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 240 Participants | 79 Participants | 161 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Psoriasis Scalp Severity Index (PSSI) Baseline Score | 21.9 score on a scale STANDARD_DEVIATION 12.25 | 20.9 score on a scale STANDARD_DEVIATION 11.7 | 22.4 score on a scale STANDARD_DEVIATION 12.52 |
| Psoriasis Symptom Diary (PSD) Total Baseline Score | 80.5 units on a scale STANDARD_DEVIATION 39.55 | 84.3 units on a scale STANDARD_DEVIATION 38.76 | 78.5 units on a scale STANDARD_DEVIATION 39.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 271 Participants | 91 Participants | 180 Participants |
| Scalp Investigator Global Assessment (S-IGA) Baseline Score 0 - clear | 0 Participants | 0 Participants | 0 Participants |
| Scalp Investigator Global Assessment (S-IGA) Baseline Score 1 - almost clear | 0 Participants | 0 Participants | 0 Participants |
| Scalp Investigator Global Assessment (S-IGA) Baseline Score 2 - mild | 32 Participants | 14 Participants | 18 Participants |
| Scalp Investigator Global Assessment (S-IGA) Baseline Score 3 - moderate | 231 Participants | 80 Participants | 151 Participants |
| Scalp Investigator Global Assessment (S-IGA) Baseline Score 4 - severe | 39 Participants | 10 Participants | 29 Participants |
| Scalp Itch Numeric Rating Scale (SI-NRS) Baseline Score | 6.5 score on a scale STANDARD_DEVIATION 2.31 | 6.6 score on a scale STANDARD_DEVIATION 2.25 | 6.4 score on a scale STANDARD_DEVIATION 2.35 |
| Sex: Female, Male Female | 143 Participants | 47 Participants | 96 Participants |
| Sex: Female, Male Male | 161 Participants | 57 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 198 | 0 / 104 |
| other Total, other adverse events | 0 / 198 | 0 / 104 |
| serious Total, serious adverse events | 1 / 198 | 0 / 104 |
Outcome results
Primary
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Time frame: Week 8
Population: All randomized participants with S-IGA score at baseline ≥2 and data available are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Roflumilast Foam 0.3% | Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale | 107 Participants |
| Vehicle Foam | Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale | 10 Participants |
Comparison: S-IGA Success at Week 8 Odds Ratiop-value: <0.000195% CI: [6.64, 32.32]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 (no symptoms) to 10 (worst imaginable symptoms). Scores range from 0 to 160, with higher scores indicating greater symptom severity.
Time frame: Baseline and Weeks 4 and 8
Population: All randomized participants are included, with multiple imputation used for missing data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Roflumilast Foam 0.3% | Change From Baseline in Psoriasis Symptoms Diary (PSD) Score | Week 4 | -45.0 score on a scale |
| Roflumilast Foam 0.3% | Change From Baseline in Psoriasis Symptoms Diary (PSD) Score | Week 8 | -55.0 score on a scale |
| Vehicle Foam | Change From Baseline in Psoriasis Symptoms Diary (PSD) Score | Week 4 | -25.4 score on a scale |
| Vehicle Foam | Change From Baseline in Psoriasis Symptoms Diary (PSD) Score | Week 8 | -27.5 score on a scale |
Comparison: Comparison of Week 4 Change from Baselinep-value: <0.000195% CI: [-27.4, -11.8]ANCOVA
Comparison: Comparison of Week 8 Change from Baselinep-value: <0.000195% CI: [-35.5, -19.5]ANCOVA
Secondary
Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8
The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Time frame: Week 8
Population: All randomized participants with data available and baseline B-IGA score ≥2 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Roflumilast Foam 0.3% | Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8 | 73 Participants |
| Vehicle Foam | Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8 | 6 Participants |
Comparison: B-IGA Success at Week 8 Odds Ratiop-value: <0.000195% CI: [3.65, 21.18]Cochran-Mantel-Haenszel
Secondary
Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)
The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Time frame: Week 8
Population: All randomized participants with data available are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Roflumilast Foam 0.3% | Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75) | 121 Participants |
| Vehicle Foam | Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75) | 19 Participants |
Comparison: PSSI-75 at Week 8 Odds Ratiop-value: <0.000195% CI: [4.81, 18.61]Cochran-Mantel-Haenszel
Secondary
Number of Participants Achieving PSSI-90
The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Time frame: Baseline and Week 8
Population: All randomized participants with data available are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Roflumilast Foam 0.3% | Number of Participants Achieving PSSI-90 | 84 Participants |
| Vehicle Foam | Number of Participants Achieving PSSI-90 | 3 Participants |
Comparison: PSSI-90 at Week 8 Odds Ratiop-value: <0.000195% CI: [8.49, 139.77]Cochran-Mantel-Haenszel
Secondary
Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
The number of participants with a baseline SI-NRS score ≥4 who achieve success (a ≥4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only.
Time frame: Baseline and Weeks 2, 4, 8
Population: All randomized participants with baseline SI-NRS score ≥4 with data available are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roflumilast Foam 0.3% | Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | Week 2 | 74 Participants |
| Roflumilast Foam 0.3% | Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | Week 4 | 98 Participants |
| Roflumilast Foam 0.3% | Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | Week 8 | 110 Participants |
| Vehicle Foam | Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | Week 4 | 19 Participants |
| Vehicle Foam | Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | Week 2 | 14 Participants |
| Vehicle Foam | Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | Week 8 | 15 Participants |
Comparison: SI-NRS Success at Week 2 Odds Ratiop-value: <0.000195% CI: [2.14, 7.71]Cochran-Mantel-Haenszel
Comparison: SI-NRS Success at Week 4 Odds Ratiop-value: <0.000195% CI: [2.93, 9.78]Cochran-Mantel-Haenszel
Comparison: SI-NRS Success at Week 8 Odds Ratiop-value: <0.000195% CI: [5.02, 18.89]Cochran-Mantel-Haenszel
Secondary
Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. Results are based on observed data only.
Time frame: Up to 8 weeks
Population: All randomized participants are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Roflumilast Foam 0.3% | Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score | 28.0 days |
| Vehicle Foam | Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score | NA days |
Comparison: Time to PSSI-50 Hazard Ratiop-value: <0.000195% CI: [2.764, 5.616]Log Rank