Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

Arcutis Biotherapeutics, Inc.432 enrolled

Overview

This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

432

Conditions

Scalp Psoriasis

Interventions

Roflumilast Foam 0.3%DRUG

Roflumilast foam 0.3%

Vehicle FoamDRUG

Vehicle foam matched to roflumilast 0.3% foam.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (49)

Outcomes

Primary Outcomes

Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8

The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline 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), with higher scores indicative of greater symptom severity.

Time frame: Week 8

Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8

The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline 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), with higher scores indicative of greater symptom severity.

Time frame: Week 8

Secondary Outcomes

Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2

The percentage of participants with SI-NRS success at Week 2 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported 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 indicative of greater symptom severity.

Time frame: Week 2

Achievement of SI-NRS Success at Week 4

The percentage of participants with SI-NRS success at Week 4 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported 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 indicative of greater symptom severity.

Data from ClinicalTrials.gov

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Arcutis Biotherapeutics Clinical Site 01

Scottsdale, Arizona, United States

Arcutis Biotherapeutics Clinical Site 50

Beverly Hills, California, United States

Arcutis Biotherapeutics Clinical Site 45

Encinitas, California, United States

Arcutis Biotherapeutics Clinical Site 64

San Diego, California, United States

Arcutis Biotherapeutics Clinical Site 72

Santa Ana, California, United States

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, United States

Arcutis Biotherapeutics Clinical Site 33

Clearwater, Florida, United States

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, United States

Arcutis Biotherapeutics Clinical Site 57

Delray Beach, Florida, United States

Arcutis Biotherapeutics Clinical Site 31

North Miami Beach, Florida, United States

...and 39 more locations

Achievement of SI-NRS Success at Week 8

The percentage of participants with SI-NRS success at Week 8 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported 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 indicative of greater symptom severity.

Time frame: Week 8

Change From Baseline in SI-NRS Score at Day 1

SI-NRS is a subject-reported 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 indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa.

Time frame: Day 1

Change From Baseline in SI-NRS Score at Day 3

Time frame: Day 3

Change From Baseline in SI-NRS Score at Week 1

Time frame: Week 1

Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at 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 ("no itch") to 10 ("worst imaginable itch"). Success is defined as achievement of a ≥ 4-point improvement from baseline in participants with a baseline WI-NRS pruritus score of ≥ 4.

Time frame: Week 8

Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)

The Psoriasis Area and Severity Index (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. A decrease from baseline indicates symptom improvement, and vice versa.

Time frame: Week 8

Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11)

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. The aggregate Itching, Pain, and Scaling score ranges from 0 to 30; the change from baseline in aggregate score was assessed per protocol only in adult participants.

Time frame: Week 8

Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8

Time frame: Week 8

Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8

Time frame: Week 8

Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8

Time frame: Week 8

Percentage of Participants Achieving PSD Total Score of 0 at Week 8

Time frame: Week 8

Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75)

The 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). 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).

Time frame: Week 8

Achievement of S-IGA Score of 'Clear' at Week 8

The percentage of participants with S-IGA score of 0 Week 8 is presented. 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), with higher scores indicative of greater symptom severity.

Time frame: Week 8

Achievement of S-IGA Success at Week 2

The percentage of participants with S-IGA success at Week 2 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. 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), with higher scores indicative of greater symptom severity.

Time frame: Week 2

Achievement of S-IGA Success at Week 4

The percentage of participants with S-IGA success at Week 4 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. 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), with higher scores indicative of greater symptom severity.

Time frame: Week 4

Change From Baseline in PASI Score at Week 2

Time frame: Week 2