Scalp and Body Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: ARQ-154
Product Code: ARQ-154
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: ROFLUMILAST
CAS Number: 162401-32-3
Concentration unit: % percent
Concentration type: equal
Concent
Sponsors
Arcutis Biotherapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants legally competent to read, write, and sign and give informed consent, or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws. 2. Males and females ages 12 years and older (inclusive) at the time of consent or assent (for adolescents) 3. Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Moderate (‘3’) at Baseline 4. Extent of scalp psoriasis involving =10% of the total scalp at Baseline 5. A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline. 6. An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild (‘2’) at Baseline 7. A PASI score of at least 2 (excluding the palms, and soles) at Baseline 8. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable disease for the past 4 weeks. 9. Psoriasis involvement on scalp and non-scalp areas totaling =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Protocol Table 1). 2. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. 3. Subjects currently taking lithium or antimalarial drugs. 4. Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors). 5. 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. 6. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements. 7. Known allergies to excipients in ARQ-151 foam (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate). 8. 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 and during the study period. 9. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin for two weeks prior to the Baseline visit and during the study period. 10. Known or suspected: • severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C) • known HIV infection 11. Subjects with PHQ-8 = 10 or modified PHQ-A = 10 at Screening or Baseline. 12. Females who are pregnant, wishing to become pregnant during the study, or are breastfeeding. 13. Previous treatment with ARQ-151 or ARQ-154. 14. Subjects who have received oral roflumilast (Daxas®, Daliresp®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks. 15. 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. 16. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of the investigational product. 17. 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. 18. 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. Subjects unable to apply product to the scalp (and/or psoriasis elsewhere) due to physical limitations. 19. 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. 20. Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal, or antiviral agents within 7 days of Baseline/Day 0. 21. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of ARQ-154 foam 0.3% vs vehicle administered QD x 8 weeks in adolescents and adults with scalp and body plaque psoriasis.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint is S-IGA Success at Week 8, defined as achievement of an S-IGA score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from Baseline. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be analyzed using a Cochran-Mantel-Haenszel test stratified by country, baseline S-IGA (2 vs. =3), and baseline B-IGA (2 vs. =3). Missing S-IGA and B-IGA scores will be imputed using multiple imputation. Sensitivity analyses of the primary endpoint may be conducted in by study site or groups of study sites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Secondary Efficacy Endpoints will include: • B-IGA Success at Week 8, defined as achievement of Body-IGA (B-IGA) score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from baseline • PSSI-75 (subjects who achieve a 75% reduction in PSSI from Baseline) at week 8 • For subjects with Baseline Scalp Itch NRS score =4, achievement of =4-point improvement from Baseline in Scalp Itch NRS at week 8 • For subjects with Baseline Scalp Itch NRS score =4, achievement of =4-point improvement from Baseline in Scalp Itch NRS at week 4 • For subjects with Baseline Scalp Itch NRS score =4, achievement of =4-point improvement from Baseline in Scalp Itch NRS at week 2 • Time to PSSI-50 • Change from Baseline in total PSD score at week 8 • Change from Baseline in total PSD score at week 4 • PSSI-90 (subjects who achieve a 90% reduction in PSSI from Baseline) at Week 8;Timepoint(s) of evaluation of this end point: Upon demonstration of statistical significance for S-IGA Success at Week 8, the secondary endpoint of B-IGA Success at Week 8 will be tested hierarchically at the 5% significance level. If the test for B-IGA Success at Week 8 is significant, the a of 0.05 will be split to test 2 families of secondary endpoints. The first family comprised of the PSSI-75, will be tested at the a = 0.03 level. If test of PSSI-75 is statistically significant, then a = 0.03 will be used to test the 4 endpoints of time to success in PSSI-50, CFB in Total PSD score at Week 8 and Week 4, and PSSI-90 at Week 8. The remaining a = 0.02 will be used to test the second family, comprised of the Scalp WI-NRS at Week 8, the Scalp WI-NRS at Week 4, and the Scalp WI-NRS at Week 2. | — |
Countries
Australia, Bulgaria, Canada, United States
Contacts
Public ContactClinical Trial Information
Arcutis Biotherapeutics, Inc.
Outcome results
None listed