Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

Scalp Psoriasis Clinical Trial

— ARRECTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028582
• Other study ID #: ARQ-154-309
• Status: Completed
• Phase: Phase 3
• Start date: August 24, 2021
• Est. completion date: June 3, 2022

Study information

• Verified date: April 2023
• Source: Arcutis Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• ARQ-154 Foam 0.3%
ARQ-154 Foam 0.3%
• ARQ-154 Vehicle
Vehicle

Locations

Country	Name	City	State
Canada	Arcutis Biotherapeutics Clinical Site 38	Ajax	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 35	Calgary	Alberta
Canada	Arcutis Biotherapeutics Clinical Site 43	Fredericton	New Brunswick
Canada	Arcutis Biotherapeutics Clinical Site 16	London	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 29	Mississauga	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 09	Montreal	Quebec
Canada	Arcutis Biotherapeutics Clinical Site 30	North Bay	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 32	Peterborough	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 37	Surrey	British Columbia
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 47	Winnepeg	Manitoba
United States	Arcutis Biotherapeutics Clinical Site 13	Arlington	Texas
United States	Arcutis Biotherapeutics Clinical Site 11	Austin	Texas
United States	Arcutis Biotherapeutics Clinical Site 50	Beverly Hills	California
United States	Arcutis Biotherapeutics Clinical Site 63	Bronx	New York
United States	Arcutis Biotherapeutics Clinical Site 33	Clearwater	Florida
United States	Arcutis Biotherapeutics Clinical Site 41	College Station	Texas
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 20	Detroit	Michigan
United States	Arcutis Biotherapeutics Clinical Site 34	East Windsor	New Jersey
United States	Arcutis Biotherapeutics Clinical Site 45	Encinitas	California
United States	Arcutis Biotherapeutics Clinical Site 23	High Point	North Carolina
United States	Arcutis Biotherapeutics Clinical Site 06	Knoxville	Tennessee
United States	Arcutis Biotherapeutics Clinical Site 04	Lake Charles	Louisiana
United States	Arcutis Biotherapeutics Clinical Site 15	Louisville	Kentucky
United States	Arcutis Biotherapeutics Clinical Site 14	New Brighton	Minnesota
United States	Arcutis Biotherapeutics Clinical Site 17	Norfolk	Virginia
United States	Arcutis Biotherapeutics Clinical Site 31	North Miami Beach	Florida
United States	Arcutis Biotherapeutics Clinical Site 05	Orlando	Florida
United States	Arcutis Biotherapeutics Clinical Site 27	Pittsburgh	Pennsylvania
United States	Arcutis Biotherapeutics Clinical Site 22	Plainfield	Illinois
United States	Arcutis Biotherapeutics Clinical Site 25	Portland	Oregon
United States	Arcutis Biotherapeutics Clinical Site 51	Rochester	New York
United States	Arcutis Biotherapeutics Clinical Site 02	Rockville	Maryland
United States	Arcutis Biotherapeutics Clinical Site 28	Rockville	Maryland
United States	Arcutis Biotherapeutics Clinical Site 10	Rolling Meadows	Illinois
United States	Arcutis Biotherapeutics Clinical Site 44	Saint Joseph	Missouri
United States	Arcutis Biotherapeutics Clinical Site 24	San Antonio	Texas
United States	Arcutis Biotherapeutics Clinical Site 54	San Antonio	Texas
United States	Arcutis Biotherapeutics Clinical Site 64	San Diego	California
United States	Arcutis Biotherapeutics Clinical Site 65	Sanford	Florida
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 01	Scottsdale	Arizona
United States	Arcutis Biotherapeutics Clinical Site 12	Tampa	Florida
United States	Arcutis Biotherapeutics Clinical Site 07	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Arcutis Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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