A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered Daily in Adolescents and Adults with Scalp and Body Psoriasis
- Conditions
- Scalp and Body Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-003354-92-BG
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
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 <25% BSA (not including palms/soles)
10. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of an acceptable effective contraception throughout the trial. Acceptable effective forms of contraception may include: combine estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progesterone only contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion, and partner’s vasectomy. If barrier methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms of conception are required. The use of abstinence as a contraceptive measure is acceptable as long as this is the preferred and usual lifestyle choice of the subject and a backup method has been identified if the subject becomes sexually active.
11. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).
12. In good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
13. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the Investigator judgment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;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 Outcome Measures
Name Time Method