Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis
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| ClinicalTrials.gov Identifier: NCT04128007 |
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Recruitment Status :
Completed
First Posted : October 16, 2019
Last Update Posted : October 19, 2020
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Sponsor:
Arcutis Biotherapeutics, Inc.
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.
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Brief Summary:
This study will assess the safety and effIcacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: ARQ-154 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 304 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis |
| Actual Study Start Date : | January 13, 2020 |
| Actual Primary Completion Date : | September 23, 2020 |
| Actual Study Completion Date : | September 25, 2020 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: ARQ-154 foam 0.3% |
Drug: ARQ-154
active vs vehicle |
| Placebo Comparator: ARQ foam VehicleRQ-154 foam Vehicle |
Drug: ARQ-154
active vs vehicle |
Primary Outcome Measures :
- Scalp Investigator Global Assessment Scale [ Time Frame: 8 weeks ]Achievement of a Scalp IGA score of 'Clear' or 'Almost Clear' plus a 2-grade 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).
Secondary Outcome Measures :
- Psoriasis Scalp Severity Index-50 score change [ Time Frame: Week 8 ]Achieve a 50% reduction in Psoriasis Scalp Severity Index (PSSI) from Baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
- Psoriasis Scalp Severity Index-score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]Time to Psoriasis Scalp Severity Index (PSSI)-50. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
- Psoriasis Area Severity Index-50 score change [ Time Frame: Week 8 ]Achieve a 50% reduction in Psoriasis Area Severity Index (PASI) from Baseline. PASI combines the assessment of the severity of lesions and the area affected into single score in the range of 0 (no disease) to 72 (maximal disease). The body is divided into 4 sections (head, arms, trunk, legs); each area is scored by itself and scores are combined into the final PASI. For each section, the percent of area of skin involved is estimated: 0 (0%) to 6 (90% - 100%). For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
- Psoriasis Area Severity Index-50 score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]Time to Psoriasis Area Severity Index (PASI)-50. PASI combines the assessment of the severity of lesions and the area affected into single score in the range of 0 (no disease) to 72 (maximal disease). The body is divided into 4 sections (head, arms, trunk, legs); each area is scored by itself and scores are combined into the final PASI. For each section, the percent of area of skin involved is estimated: 0 (0%) to 6 (90% - 100%). For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
- Psoriasis Scalp Severity Index-75 score change [ Time Frame: Week 8 ]Achieve a 75% reduction in Psoriasis Scalp Severity Index (PSSI) from Baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
- Psoriasis Scalp Severity Index-75 score change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]Time to Psoriasis Scalp Severity Index (PSSI)-75. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
- Scalp Itch Numerical Rating Score score change [ Time Frame: Weeks 2, 4, 8 ]For subjects with a Baseline Scalp Itch Numerical Rating Score (SI-NRS) of > 4, achievement of a > 4-point improvement from Baseline at Weeks 2, 4, and 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").
- Psoriasis Symptoms Diary score change [ Time Frame: Weeks 4 and 8 ]Change from Baseline in total Psoriasis Symptoms Diary (PSD) score at Weeks 4 and 8. The PSD is a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance
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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:
- Participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws.
- Males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents).
- Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Mild ('2') at Baseline.
- A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline.
- A PASI score of at least 2 (excluding the palms and soles) at Baseline.
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
- Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
- Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- 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 are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
Exclusion Criteria:
- Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Subjects currently taking lithium or antimalarial drugs.
- Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).
- Current diagnosis of non-plaque forms of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- Known allergies to excipients in ARQ-154.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects with PHQ-8 >/= 10 or modified PHQ-A >/= 10 at Screening or Baseline.
- 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 with a history of chronic alcohol or drug abuse within 6 months of initiation of the investigational product.
- Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
- Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
- Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal, or antiviral agents within 7 days of Baseline/Day 0.
- 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.
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): NCT04128007
Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
| Responsible Party: | Arcutis Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04128007 |
| Other Study ID Numbers: |
ARQ-154-204 |
| First Posted: | October 16, 2019 Key Record Dates |
| Last Update Posted: | October 19, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |