Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
- Conditions
- Scalp Psoriasis
- Interventions
- Drug: ARQ-154 Foam 0.3%Drug: ARQ-154 Vehicle
- Registration Number
- NCT05028582
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- Brief Summary
This study will assess the safety and efficacy of ARQ-154 foam vs vehicle applied once daily for 8 weeks 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 foam is applied once daily for 8 weeks to subjects with scalp and body psoriasis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 432
- For adult subjects: Participants legally competent to read, write, and sign and give informed consent. For adolescent subjects: Informed consent of a parent(s) or legal guardian, and assent by the subjects, as required by local laws.
- Males and females ages 12 years and older (inclusive) at the time of consent or assent.
- Scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least Moderate ('3') at Baseline.
- Extent of scalp psoriasis involving ≥ 10% of the total scalp at Baseline.
- A Psoriasis Scalp Severity Index (PSSI) of at least 6 at Baseline.
- An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Baseline.
- A PASI score of at least 2 (excluding palms and soles) at Baseline.
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
- Total overall psoriasis involvement on scalp and non-scalp areas ≤ 25% BSA (not including palms/soles) at Baseline. Total non-scalp BSA should not exceed 20%.
- Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception or a barrier method of contraception throughout the study according to Contraception Requirements for the protocol.
- Females of non-childbearing potential must either be premenarchal, post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization according to Contraception Requirements for the protocol. Prepubescent females must agree to be abstinent during the study.
- 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 who cannot discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the Baseline visit and during the study.
- Planned excessive exposure to treated area(s) to either natural or artificial sunlight, tanning bed, or other LED.
- Previous treatment with ARQ-151 or ARQ-154.
- 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 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.
- Any condition that in the Investigator's assessment would preclude the subject from participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARQ-154 Foam 0.3% ARQ-154 Foam 0.3% ARQ-154 Foam 0.3% ARQ-154 Vehicle ARQ-154 Vehicle ARQ-154 Vehicle
- Primary Outcome Measures
Name Time Method Scalp Investigator Global Assessment (S-IGA) Score Change 8 weeks S-IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4).
Body Investigator Global Assessment (B-IGA) Score Change 8 weeks B-IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4).
- Secondary Outcome Measures
Name Time Method SI-NRS (Scalp Itch-Numeric Rating Score) Success, defined as achievement of a ≥ 4-point improvement from Baseline. Week 2 SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score) Day 1 SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Change From Baseline (CFB) in PSD (Psoriasis Symptoms Diary) items related to Itching, Pain, and Scaling (Questions 1, 9, and 11) aggregate score at Week 8 Week 8 The PSD is a 16-item assessment that measures psoriasis symptoms and impact on functional health. Symptom items assess the severity and bother of psoriasis-related itching, stinging, burning, pain, scaling, and skin color.
Psoriasis Symptoms Diary (PSD) Item related to Itching (Question 1) = 0 at Week 8 Week 8 The PSD is a 16-item assessment that measures psoriasis symptoms and impact on functional health. Symptom items assess the severity and bother of psoriasis-related itching, stinging, burning, pain, scaling, and skin color.
Psoriasis Symptoms Diary (PSD) Item related to Pain (Question 9) = 0 at Week 8 Week 8 The PSD is a 16-item assessment that measures psoriasis symptoms and impact on functional health. Symptom items assess the severity and bother of psoriasis-related itching, stinging, burning, pain, scaling, and skin color.
Psoriasis Scalp Severity Index (PSSI-75) Week 8 The PSSI is used for the measurement of severity of psoriasis. PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease).The PSSI is used for the measurement of severity of psoriasis.
PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease).Change from Baseline (CFB) in PASI (Psoriasis Scalp Severity Index) Week 2 A PASI score is a tool used to measure the severity and extent of psoriasis.
S-IGA (Scalp Investigator Global Assessment) score of 'Clear' Week 8 S-IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 4. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4).
S-IGA (Scalp Investigator Global Assessment) Success Week 2 S-IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4).
Psoriasis Symptoms Diary (PSD) total Score = 0 Week 8 The PSD is a 16-item assessment that measures psoriasis symptoms and impact on functional health. Symptom items assess the severity and bother of psoriasis-related itching, stinging, burning, pain, scaling, and skin color.
In subjects with a Baseline WI-NRS (Worst Itch-Numeric Rating Score) pruritus score of ≥ 4, achievement of a ≥ 4-point improvement from Baseline Week 8 WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch".
In subjects with a Baseline SI-NRS (Scalp Itch-Numeric Rating Score) pruritus score of ≥ 4, SI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. Week 8 SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
PASI-75 (Psoriasis Area and Severity Index-75) Week 8 A PASI score is a tool used to measure the severity and extent of psoriasis. Psoriasis Area and Severity Index-75; subjects who achieve a 75% reduction in PASI from Baseline.
Psoriasis Symptoms Diary (PSD) related to Scaling (Question 11) = 0 at Week 8 Week 8 The PSD is a 16-item assessment that measures psoriasis symptoms and impact on functional health. Symptom items assess the severity and bother of psoriasis-related itching, stinging, burning, pain, scaling, and skin color.
Trial Locations
- Locations (49)
Arcutis Biotherapeutics Clinical Site 13
🇺🇸Arlington, Texas, United States
Arcutis Biotherapeutics Clinical Site 31
🇺🇸North Miami Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 72
🇺🇸Santa Ana, California, United States
Arcutis Biotherapeutics Clinical Site 28
🇺🇸Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 12
🇺🇸Tampa, Florida, United States
Arcutis Biotherapeutics Clinical Site 50
🇺🇸Beverly Hills, California, United States
Arcutis Biotherapeutics Clinical Site 33
🇺🇸Clearwater, Florida, United States
Arcutis Biotherapeutics Clinical Site 44
🇺🇸Saint Joseph, Missouri, United States
Arcutis Biotherapeutics Clinical Site 06
🇺🇸Knoxville, Tennessee, United States
Arcutis Biotherapeutics Clinical Site 27
🇺🇸Pittsburgh, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 65
🇺🇸Sanford, Florida, United States
Arcutis Biotherapeutics Clinical Site 01
🇺🇸Scottsdale, Arizona, United States
Arcutis Biotherapeutics Clinical Site 45
🇺🇸Encinitas, California, United States
Arcutis Biotherapeutics Clinical Site 57
🇺🇸Delray Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 14
🇺🇸New Brighton, Minnesota, United States
Arcutis Biotherapeutics Clinical Site 43
🇨🇦Fredericton, New Brunswick, Canada
Arcutis Biotherapeutics Clinical Site 64
🇺🇸San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 25
🇺🇸Portland, Oregon, United States
Arcutis Biotherapeutics Clinical Site 24
🇺🇸San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 21
🇺🇸Santa Monica, California, United States
Arcutis Biotherapeutics Clinical Site 42
🇺🇸Coral Gables, Florida, United States
Arcutis Biotherapeutics Clinical Site 22
🇺🇸Plainfield, Illinois, United States
Arcutis Biotherapeutics Clinical Site 10
🇺🇸Rolling Meadows, Illinois, United States
Arcutis Biotherapeutics Clinical Site 05
🇺🇸Orlando, Florida, United States
Arcutis Biotherapeutics Clinical Site 04
🇺🇸Lake Charles, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 02
🇺🇸Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 20
🇺🇸Detroit, Michigan, United States
Arcutis Biotherapeutics Clinical Site 15
🇺🇸Louisville, Kentucky, United States
Arcutis Biotherapeutics Clinical Site 63
🇺🇸Bronx, New York, United States
Arcutis Biotherapeutics Clinical Site 51
🇺🇸Rochester, New York, United States
Arcutis Biotherapeutics Clinical Site 23
🇺🇸High Point, North Carolina, United States
Arcutis Biotherapeutics Clinical Site 54
🇺🇸San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 37
🇨🇦Surrey, British Columbia, Canada
Arcutis Biotherapeutics Clinical Site 47
🇨🇦Winnepeg, Manitoba, Canada
Arcutis Biotherapeutics Clinical Site 16
🇨🇦London, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 38
🇨🇦Ajax, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 29
🇨🇦Mississauga, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 30
🇨🇦North Bay, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 32
🇨🇦Peterborough, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 71
🇨🇦Toronto, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 36
🇨🇦Waterloo, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 49
🇨🇦Windsor, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 09
🇨🇦Montreal, Quebec, Canada
Arcutis Biotherapeutics Clinical Site 11
🇺🇸Austin, Texas, United States
Arcutis Biotherapeutics Clinical Site 07
🇺🇸West Jordan, Utah, United States
Arcutis Biotherapeutics Clinical Site 34
🇺🇸East Windsor, New Jersey, United States
Arcutis Biotherapeutics Clinical Site 41
🇺🇸College Station, Texas, United States
Arcutis Biotherapeutics Clinical Site 17
🇺🇸Norfolk, Virginia, United States
Arcutis Biotherapeutics Clinical Site 35
🇨🇦Calgary, Alberta, Canada
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