Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

Study Overview
=================
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.

Official Title
-----------------
A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)

Conditions
-----------------
Scalp Psoriasis

Intervention / Treatment
-----------------
* Drug: ARQ-154 Foam 0.3%
* Drug: ARQ-154 Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARQ-154 Foam 0.3%<br>ARQ-154 Foam 0.3% | Drug: ARQ-154 Foam 0.3%<br>* ARQ-154 Foam 0.3%<br>|
| Placebo Comparator: ARQ-154 Vehicle<br>ARQ-154 Vehicle | Drug: ARQ-154 Vehicle<br>* Vehicle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp Investigator Global Assessment (S-IGA) Score Change | 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). | 8 weeks | 
| Body Investigator Global Assessment (B-IGA) Score Change | 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). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Week 8 | 
| SI-NRS (Scalp Itch-Numeric Rating Score) Success, defined as achievement of a ≥ 4-point improvement from Baseline. | 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). | Week 4 | 
| SI-NRS (Scalp Itch-Numeric Rating Score) Success, defined as achievement of a ≥ 4-point improvement from Baseline. | 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). | Week 2 | 
| Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score) | 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). | Week 1 | 
| Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score) | 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). | 72 Hours | 
| Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score) | 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). | Day 1 | 
| In subjects with a Baseline WI-NRS (Worst Itch-Numeric Rating Score) pruritus score of ≥ 4, achievement of a ≥ 4-point improvement from Baseline | 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. | Week 8 | 
| PASI-75 (Psoriasis Area and Severity Index-75) | 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. | Week 8 | 
| 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 | 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. | Week 8 | 
| Psoriasis Symptoms Diary (PSD) related to Scaling (Question 11) = 0 at 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. | Week 8 | 
| Psoriasis Symptoms Diary (PSD) Item related to Itching (Question 1) = 0 at 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. | Week 8 | 
| Psoriasis Symptoms Diary (PSD) Item related to Pain (Question 9) = 0 at 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. | Week 8 | 
| Psoriasis Scalp Severity Index (PSSI-75) | 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). | Week 8 | 
| S-IGA (Scalp Investigator Global Assessment) score of 'Clear' | 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). | Week 8 | 
| S-IGA (Scalp Investigator Global Assessment) Success | 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). | Week 4 | 
| Change from Baseline (CFB) in PASI (Psoriasis Scalp Severity Index) | A PASI score is a tool used to measure the severity and extent of psoriasis. | Week 2 | 
| S-IGA (Scalp Investigator Global Assessment) Success | 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). | Week 2 | 
| Psoriasis Symptoms Diary (PSD) total Score = 0 | 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. | Week 8 |