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Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) (ARRECTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05028582
Recruitment Status : Recruiting
First Posted : August 31, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: ARQ-154 Foam 0.3% Drug: ARQ-154 Vehicle Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)
Actual Study Start Date : August 24, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: ARQ-154 Foam 0.3%
ARQ-154 Foam 0.3%
Drug: ARQ-154 Foam 0.3%
ARQ-154 Foam 0.3%

Placebo Comparator: ARQ-154 Vehicle
ARQ-154 Vehicle
Drug: ARQ-154 Vehicle
Vehicle




Primary Outcome Measures :
  1. Scalp Investigator Global Assessment (S-IGA) Score Change [ Time Frame: 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).

  2. Body Investigator Global Assessment (B-IGA) Score Change [ Time Frame: 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 :
  1. 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. [ Time Frame: 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").

  2. 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. [ Time Frame: Week 4 ]
    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").

  3. 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. [ Time Frame: 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").

  4. Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score) [ Time Frame: Week 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").

  5. Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score) [ Time Frame: 72 Hours ]
    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").

  6. Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score) [ Time Frame: 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").

  7. In subjects with a Baseline WI-NRS (Worst Itch-Numeric Rating Score) pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline [ Time Frame: 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".

  8. PASI-75 (Psoriasis Area and Severity Index-75) [ Time Frame: 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.

  9. Change From Baseline (CFB) in total PSD (Psoriasis Symptoms Diary) score [ Time Frame: 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.

  10. Change From Baseline (CFB) in total PSD (Psoriasis Symptoms Diary) score [ Time Frame: Week 4 ]
    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.

  11. Change From Baseline (CFB) in total PSD (Psoriasis Symptoms Diary) score [ Time Frame: Week 2 ]
    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.

  12. PSSI-75 (Psoriasis Scalp Severity Index) [ Time Frame: 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). PSSI-75 indicates at least a 75% improvement in the PSSI score from Baseline.

  13. S-IGA (Scalp Investigator Global Assessment) of 'Clear' at Week 8 [ Time Frame: Week 8 ]
    The S-IGA is a global assessment scale that has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4).

  14. SI-IGA (Scalp Investigator Global Assessment) [ Time Frame: Week 4 ]
    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).

  15. Change from Baseline (CFB) in PASI (Psoriasis Scalp Severity Index) [ Time Frame: Week 2 ]
    A PASI score is a tool used to measure the severity and extent of psoriasis.

  16. S-IGA (Scalp-Investigator Global Assessment) Success [ Time Frame: Week 2 ]
    S-IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05028582


Contacts
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Contact: Arcutis Study Inquiry 805.418.5006 Ext. 5 studyinquiry@arcutis.com

Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05028582    
Other Study ID Numbers: ARQ-154-309
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases